BMJ medicine最新文献

{"title":"Long covid as a long term condition.","authors":"Manoj Sivan, Darren Charles C Greenwood, Tracey Smith","doi":"10.1136/bmjmed-2025-001366","DOIUrl":"10.1136/bmjmed-2025-001366","url":null,"abstract":"","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"4 1","pages":"e001366"},"PeriodicalIF":0.0,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792270/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143191291","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}

{"title":"Blood level of neurofilament light chain as a biomarker for neurological disorders.","authors":"Martin R Turner, Alexander G Thompson, Charlotte E Teunissen","doi":"10.1136/bmjmed-2024-000958","DOIUrl":"10.1136/bmjmed-2024-000958","url":null,"abstract":"","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"4 1","pages":"e000958"},"PeriodicalIF":0.0,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749884/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143026072","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}

{"title":"Vaccine effectiveness against mild and severe covid-19 in pregnant individuals and their infants in England: test negative case-control study.","authors":"Freja C M Kirsebom, Nick Andrews, Anna A Mensah, Julia Stowe, Shamez Ladhani, Mary Ramsay, Jamie Lopez Bernal, Helen Julia Campbell","doi":"10.1136/bmjmed-2023-000696","DOIUrl":"10.1136/bmjmed-2023-000696","url":null,"abstract":"<p><strong>Objective: </strong>To estimate real world vaccine effectiveness against symptomatic disease and hospital admission with the delta and omicron variants of the SARS-CoV-2 virus in pregnant individuals, and to estimate the protection conferred by previous infection and maternal vaccination in their infants.</p><p><strong>Design: </strong>Test negative case-control study.</p><p><strong>Setting: </strong>Community and hospital testing for covid-19, in England, 26 April 2021 to 9 January 2022 (delta variant period) and 29 November 2021 to 31 March 2022 (omicron variant period). Testing data were linked to Hospital Episode Statistics and Maternal Services Data Set (for data on pregnant individuals and infants), National Immunisation Management System (for covid-19 vaccinations), and Secondary Uses Service (for hospital admissions).</p><p><strong>Participants: </strong>35 206 negative and 16 693 positive eligible test results in the delta variant period from pregnant individuals with symptoms of infection, aged 16-55 years, whose pregnancy ended in 2021, and 5974 negative and 4715 positive eligible test results in the omicron variant period. For infants born in 2021, 23 053 negative and 2924 positive eligible test results in the delta variant period and 13 908 negative and 5669 positive test results from infants in the omicron period.</p><p><strong>Main outcome measures: </strong>Vaccine effectiveness against symptomatic disease and hospital admission with the delta and omicron variants of the SARS-CoV-2 virus in pregnant women. Also, effectiveness of maternal vaccination and the protection conferred by previous infection in mothers in preventing symptomatic disease and hospital admission in their infants in the first six months of life. Symptomatic SARS-CoV-2 infection was confirmed by a positive polymerase chain reaction test result.</p><p><strong>Results: </strong>Vaccine effectiveness against symptomatic disease (delta and omicron infection) and against hospital admission (delta infection only) in pregnant individuals was high, as seen in the general population. A booster dose of vaccine gave sustained protection, with no evidence of waning up to 15 weeks after vaccination. Vaccine effectiveness against symptomatic disease peaked at 98.4% (95% confidence interval (CI) 88.4% to 99.8%) and 80.1% (73.8% to 84.9%) against the delta and omicron variants, respectively, after the booster dose of vaccine. Vaccine effectiveness after a two dose primary schedule against hospital admission with delta infection peaked at 92.7% (95% CI 79.9% to 97.4%) in pregnant individuals. Maternal vaccination during and after pregnancy also provided sustained protection from symptomatic disease and hospital admission after delta and omicron infection in infants aged up to six months, with the highest protection seen when maternal vaccination occurred during later pregnancy. The effectiveness of two maternal doses when the last dose was given in the third trimester","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000696"},"PeriodicalIF":0.0,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11789471/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123139","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}

{"title":"Caesarean section and risk of infection in offspring: systematic review and meta-analysis of observational studies.","authors":"Isobel Masson Francis Todd, Maria Christine Magnus, Lars Henning Pedersen, David Burgner, Jessica Eden Miller","doi":"10.1136/bmjmed-2024-000995","DOIUrl":"10.1136/bmjmed-2024-000995","url":null,"abstract":"<p><strong>Objective: </strong>To compare the risk of hospital admissions with infections and infections not in hospital in children born by caesarean section with children born by vaginal birth.</p><p><strong>Data sources: </strong>Medline, Embase, and PubMed were searched with no restriction on start date up to 12 February 2024.</p><p><strong>Study selection: </strong>Observational studies were included that reported the association between caesarean section and vaginal birth in relation to the risk of infections (both those that lead to hospital admission and those that do not) up to 18 years of age. Studies were excluded if they were not representative of a general population or if they focused on congenital, neonatal, or vertically acquired infections. No restrictions were made for language, publication date, or setting.</p><p><strong>Review methods: </strong>Findings for hospital admissions with infection were synthesised by meta-analyses of specific infection outcomes and type of caesarean birth (emergency <i>v</i> elective) and findings for other infections (ie, infection episodes reported by parents and primary care visits) by direction of effect. Risk of bias was assessed using the ROBINS-E tool and the overall certainty of evidence through the GRADE framework.</p><p><strong>Results: </strong>31 eligible studies of over 10 million children were included. Findings were from population-based birth cohorts and registry data linkage studies in high income countries. Cohort sizes ranged from 288 to 7.2 million and follow up age was from one to 18 years. Outcomes included overall and specific clinical categories of infection. From studies of overall admission to hospital with infection, the proportion of children admitted ranged between 9-29% across exposure groups. In random-effects meta-analyses combining hazard ratios, children delivered by caesarean section had an increased rate of hospital admission with infections overall and in three common clinical infection categories: (1) overall admissions to hospital with infection (emergency caesarean section: n=6 study populations, hazard ratio 1.10 (95% confidence interval 1.06 to 1.14), <math><mi>τ</mi></math> <sup>2</sup>=0.0009, I<sup>2</sup>=96%; elective caesarean section: n=7, 1.12 (1.09 to 1.15), <math><mi>τ</mi></math> <sup>2</sup>=0.0006, I<sup>2</sup>=88%); (2) admission to hospital for upper respiratory infections (emergency caesarean section: n=7, 1.11 (1.09 to 1.13), <math><mi>τ</mi></math> <sup>2</sup>=0.0003, I<sup>2</sup>=73%; elective caesarean section: n=7, 1.16 (1.12 to 1.20), <math><mi>τ</mi></math> <sup>2</sup>=0.0012, I<sup>2</sup>=89%); (3) admission to hospital for lower respiratory infections (emergency caesarean section: n=8, 1.09 (1.06 to 1.12), <math><mi>τ</mi></math> <sup>2</sup>=0.0010, I<sup>2</sup>=88%; elective caesarean section: n=8, 1.13 (1.10 to 1.16), <math><mi>τ</mi></math> <sup>2</sup>=0.0009, I<sup>2</sup>=84%); (4) admission to hospital for gastrointesti","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000995"},"PeriodicalIF":0.0,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603743/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142752553","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}

{"title":"Comparative effectiveness of monovalent XBB.1.5 containing covid-19 mRNA vaccines in Denmark, Finland, and Sweden: target trial emulation based on registry data.","authors":"Niklas Worm Andersson, Emilia Myrup Thiesson, Nicklas Pihlström, Jori Perälä, Kristýna Faksová, Mie Agermose Gram, Eero Poukka, Tuija Leino, Rickard Ljung, Anders Hviid","doi":"10.1136/bmjmed-2024-001074","DOIUrl":"10.1136/bmjmed-2024-001074","url":null,"abstract":"<p><strong>Abstract: </strong></p><p><strong>Objective: </strong>To estimate the effectiveness of vaccination with a monovalent covid-19 mRNA vaccine containing the omicron XBB.1.5 subvariant against severe covid-19 disease in Denmark, Finland, and Sweden.</p><p><strong>Design: </strong>Target trial emulation based on registry data.</p><p><strong>Setting: </strong>Denmark, Finland, and Sweden, 1 October 2023 to 21 April 2024.</p><p><strong>Participants: </strong>Source population of 3 898 264 individuals eligible for vaccination with the XBB.1.5 containing covid-19 mRNA vaccine at the start of the study on 1 October 2023. Study cohort comprised 1 876 282 recipients of an XBB.1.5 containing vaccine during the study period matched with 1 876 282 non-recipients. Individuals were aged ≥65 years (mean age 75.4 years, standard deviation 7.4 years) and had received at least four doses of a previous covid-19 vaccine.</p><p><strong>Main outcome measures: </strong>Cumulative incidences of hospital admissions and deaths related to covid-19 in a follow-up period of 24 weeks after immunisation (defined as one week after vaccination) in recipients of an XBB.1.5 containing covid-19 mRNA vaccine and matched non-recipients. Cumulative incidences were used to calculate comparative vaccine effectiveness (1-risk ratio) and risk differences.</p><p><strong>Results: </strong>The associated comparative vaccine effectiveness was 57.9% (95% confidence interval (CI) 49.9% to 65.8%) against hospital admission for covid-19 (1085 <i>v</i> 2635 events) and 75.2% (70.6% to 79.9%) against deaths related to covid-19 disease (348 <i>v</i> 1458 events) after 24 weeks of follow-up. This result corresponded to 154.7 (95% CI 78.3 to 231.0) hospital admissions for covid-19 and 120.3 (110.5 to 130.2) deaths prevented per 100 000 individuals who were vaccinated with an XBB.1.5 containing vaccine. The associated comparative vaccine effectiveness was similar irrespective of sex, age group (65-74 <i>v</i> ≥75 years), number of doses of previous covid-19 vaccines, subgroup of co-administered seasonal influenza vaccines, and period of when either the omicron XBB or BA.2.86 sublineage was predominant. Although the observed reduction in risk was highest during the first weeks after vaccination, comparative vaccine effectiveness was well maintained after 24 weeks of follow-up.</p><p><strong>Conclusions: </strong>In this study, in adults aged ≥65 years, vaccination with a monovalent XBB.1.5 containing covid-19 mRNA vaccine was associated with reduced rates of hospital admissions for covid-19 and deaths related to covid-19, during the autumn and winter of 2023-24 in Denmark, Finland, and Sweden.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e001074"},"PeriodicalIF":0.0,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11789462/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123031","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}

{"title":"Impact of multiple long term conditions on hospital admission and mortality during winter: importance of linked, population scale healthcare data.","authors":"Jonathan Adam Batty, Lesley Smith, Marlous Hall","doi":"10.1136/bmjmed-2024-001114","DOIUrl":"10.1136/bmjmed-2024-001114","url":null,"abstract":"","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e001114"},"PeriodicalIF":0.0,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11580320/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689864","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}

{"title":"Combinations of multiple long term conditions and risk of hospital admission or death during winter 2021-22 in England: population based cohort study.","authors":"Nazrul Islam, Sharmin Shabnam, Nusrat Khan, Clare Gillies, Francesco Zaccardi, Amitava Banerjee, Vahé Nafilyan, Kamlesh Khunti, Hajira Dambha-Miller","doi":"10.1136/bmjmed-2024-001016","DOIUrl":"10.1136/bmjmed-2024-001016","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To describe which combinations of long term conditions were associated with a higher risk of hospital admission or death during winter 2021-22 (the third wave of the covid-19 pandemic) in adults in England.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design: &lt;/strong&gt;Population based cohort study.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Setting: &lt;/strong&gt;Linked primary and secondary care data from the General Practice Extraction Service Data for Pandemic Planning and Research (GDPPR) database, Hospital Episode Statistics, and Office for National Statistics death registry, comprising pseudoanonymised routinely collected electronic medical records from the whole population of England registered at a general practice, 1 December 2021 to 31 March 2022.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Participants: &lt;/strong&gt;48 253 125 individuals, registered in GDPPR in England, aged ≥18 years, and alive on 1 December 2021.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes measures: &lt;/strong&gt;All cause hospital admissions and deaths associated with combinations of multiple long term conditions compared with those with no long term conditions, during the winter season (1 December 2021 to 31 March 2022). Overdispersed Poisson regression models were used to estimate the incidence rate ratios after adjusting for age, sex, ethnic group, and index of multiple deprivation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Complete data were available for 48 253 125 adults, of whom 15 million (31.2%) had multiple long term conditions. Rates of hospital admissions and deaths among individuals with no long term conditions were 96.3 and 0.8 per 1000 person years, respectively. Compared with those with no long term conditions, the adjusted incidence rate ratio of hospital admissions were 11.0 (95% confidence interval (CI) 9.4 to 12.7) for those with a combination of cancer, chronic kidney disease, cardiovascular disease, and type 2 diabetes mellitus; 9.8 (8.3 to 11.4) for those with cancer, chronic kidney disease, cardiovascular disease, and osteoarthritis; and 9.6 (8.6 to 10.7) for those with cancer, chronic kidney disease, and cardiovascular disease. Compared with those with no long term conditions, the adjusted rate ratio of death was 21.4 (17.5 to 26.0) for those with chronic kidney disease, cardiovascular disease, and dementia; 23.2 (17.5 to 30.3) for those with cancer, chronic kidney disease, cardiovascular disease, and dementia; and 24.3 (19.1 to 30.4) for those with chronic kidney disease, cardiovascular disease, dementia, and osteoarthritis. Cardiovascular disease with dementia appeared in all of the top five combinations of multiple long term conditions for mortality, and this two disease combination was associated with a substantially higher rate of death than many three, four, and five disease combinations.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;In this study, rates of hospital admission and death varied by combinations of multiple long term conditions and were substantially higher in those with than in those without any long term conditions. High risk ","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e001016"},"PeriodicalIF":0.0,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11580288/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689862","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}

{"title":"Risk of dementia associated with anticholinergic drugs for overactive bladder in adults aged ≥55 years: nested case-control study.","authors":"Barbara Iyen, Carol Coupland, Brian Gregory Bell, Darren M Ashcroft, Martin William Orrell, Delia Bishara, Tom Dening, Anthony J Avery","doi":"10.1136/bmjmed-2023-000799","DOIUrl":"10.1136/bmjmed-2023-000799","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Abstract: &lt;/strong&gt;&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To investigate whether different anticholinergic drug treatments for overactive bladder have differential risks for incident dementia, in a large representative population of older adults in England.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design: &lt;/strong&gt;Nested case-control study.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Setting: &lt;/strong&gt;General practices in England providing data to the Clinical Practice Research Datalink (CPRD) GOLD database, with linked patient admission records from secondary care (Hospital Episode Statistics), 1 January 2006 and 16 February 2022.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Participants: &lt;/strong&gt;170 742 patients aged ≥55 years, with a first reported diagnosis of dementia during the study period, matched by age, sex, and general practice with 804 385 individuals without dementia (controls).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interventions: &lt;/strong&gt;Cumulative drug use (defined using total standardised daily dose) of different anticholinergic drugs used for the treatment of an overactive bladder, and a non-anticholinergic drug, mirabegron, in the period 3-16 years before a diagnosis of dementia (or equivalent date in matched controls).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcome measures: &lt;/strong&gt;Odds ratios for onset of dementia associated with the different anticholinergic drugs used for the treatment of an overactive bladder, adjusted for sociodemographic characteristics, clinical comorbidities, and use of other anticholinergic drug treatments.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study population comprised 62.6% women, and median age was 83 (interquartile range 77-87) years. 15 418 (9.0%) patients with dementia and 63 369 (7.9%) controls without dementia had used anticholinergic drugs for the treatment of an overactive bladder in the 3-16 years before diagnosis (or equivalent date for controls). The adjusted odds ratio for dementia associated with the use of any anticholinergic drug used to treat an overactive bladder was 1.18 (95% confidence interval (CI) 1.16 to 1.20), and was higher in men (1.22, 1.18 to 1.26) than women (1.16, 1.13 to 1.19). The risk of dementia was substantially increased with the use of oxybutynin hydrochloride (adjusted odds ratio 1.31, 95% CI 1.21 to 1.42 and 1.28, 1.15 to 1.43 for use of 366-1095 and &gt;1095 total standardised daily doses, respectively), solifenacin succinate (1.18, 1.09 to 1.27 and 1.29, 1.19 to 1.39), and tolterodine tartrate (1.27, 1.19 to 1.37 and 1.25, 1.17 to 1.34). No significant increases in the risk of dementia associated with darifenacin, fesoterodine fumarate, flavoxate hydrochloride, propiverine hydrochloride, and trospium chloride were found. The association between mirabegron, a non-anticholinergic drug, and dementia was variable across the dose categories and might be caused by previous use of anticholinergic drugs for the treatment of an overactive bladder in these individuals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Of the different anticholinergic drugs used to treat an overactive bladder, oxybutynin hyd","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000799"},"PeriodicalIF":0.0,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11580265/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689866","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}

{"title":"Characteristics of non-randomised studies of drug treatments: cross sectional study.","authors":"Sally Yaacoub, Raphael Porcher, Anna Pellat, Hillary Bonnet, Viet-Thi Tran, Philippe Ravaud, Isabelle Boutron","doi":"10.1136/bmjmed-2024-000932","DOIUrl":"10.1136/bmjmed-2024-000932","url":null,"abstract":"<p><strong>Abstract: </strong></p><p><strong>Objective: </strong>To examine the characteristics of comparative non-randomised studies that assess the effectiveness or safety, or both, of drug treatments.</p><p><strong>Design: </strong>Cross sectional study.</p><p><strong>Data sources: </strong>Medline (Ovid), for reports published from 1 June 2022 to 31 August 2022.</p><p><strong>Eligibility criteria for selecting studies: </strong>Reports of comparative non-randomised studies that assessed the effectiveness or safety, or both, of drug treatments were included. A randomly ordered sample was screened until 200 eligible reports were found. Data on general characteristics, reporting characteristics, and time point alignment were extracted, and possible related biases, with a piloted form inspired by reporting guidelines and the target trial emulation framework.</p><p><strong>Results: </strong>Of 462 reports of non-randomised studies identified, 262 studies were excluded (32% had no comparator and 25% did not account for confounding factors). To assess time point alignment and possible related biases, three study time points were considered: eligibility, treatment assignment, and start of follow-up. Of the 200 included reports, 70% had one possible bias, related to: inclusion of prevalent users in 24%, post-treatment eligibility criteria in 32%, immortal time periods in 42%, and classification of treatment in 23%. Reporting was incomplete, and only 2% reported all six of the key elements considered: eligibility criteria (87%), description of treatment (46%), deviations in treatment (27%), causal contrast (11%), primary outcomes (90%), and confounding factors (88%). Most studies used routinely collected data (67%), but only 7% reported using validation studies of the codes or algorithms applied to select the population. Only 7% of reports mentioned registration on a trial registry and 3% had an available protocol.</p><p><strong>Conclusions: </strong>The findings of the study suggest that although access to real world evidence could be valuable, the robustness and transparency of non-randomised studies need to be improved.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000932"},"PeriodicalIF":0.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579539/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689861","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}

{"title":"Therapeutic drug monitoring for immune mediated inflammatory diseases.","authors":"Neil Chanchlani, Zenas Z N Yiu, Lisa K Stamp, Andrew S Day","doi":"10.1136/bmjmed-2024-001130","DOIUrl":"10.1136/bmjmed-2024-001130","url":null,"abstract":"","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e001130"},"PeriodicalIF":0.0,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579535/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689868","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}