BMJ medicinePub Date : 2024-11-12eCollection Date: 2024-01-01DOI: 10.1136/bmjmed-2024-001016
Nazrul Islam, Sharmin Shabnam, Nusrat Khan, Clare Gillies, Francesco Zaccardi, Amitava Banerjee, Vahé Nafilyan, Kamlesh Khunti, Hajira Dambha-Miller
{"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":"<p><strong>Objective: </strong>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.</p><p><strong>Design: </strong>Population based cohort study.</p><p><strong>Setting: </strong>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.</p><p><strong>Participants: </strong>48 253 125 individuals, registered in GDPPR in England, aged ≥18 years, and alive on 1 December 2021.</p><p><strong>Main outcomes measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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}
BMJ medicinePub Date : 2024-11-12eCollection Date: 2024-01-01DOI: 10.1136/bmjmed-2023-000799
Barbara Iyen, Carol Coupland, Brian Gregory Bell, Darren M Ashcroft, Martin William Orrell, Delia Bishara, Tom Dening, Anthony J Avery
{"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":"<p><strong>Abstract: </strong></p><p><strong>Objective: </strong>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.</p><p><strong>Design: </strong>Nested case-control study.</p><p><strong>Setting: </strong>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.</p><p><strong>Participants: </strong>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).</p><p><strong>Interventions: </strong>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).</p><p><strong>Main outcome measures: </strong>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.</p><p><strong>Results: </strong>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 >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.</p><p><strong>Conclusions: </strong>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}
BMJ medicinePub Date : 2024-10-30eCollection Date: 2024-01-01DOI: 10.1136/bmjmed-2024-000932
Sally Yaacoub, Raphael Porcher, Anna Pellat, Hillary Bonnet, Viet-Thi Tran, Philippe Ravaud, Isabelle Boutron
{"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}
BMJ medicinePub Date : 2024-10-28eCollection Date: 2024-01-01DOI: 10.1136/bmjmed-2024-001130
Neil Chanchlani, Zenas Z N Yiu, Lisa K Stamp, Andrew S Day
{"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}
BMJ medicinePub Date : 2024-10-28eCollection Date: 2024-01-01DOI: 10.1136/bmjmed-2024-000998
Dena Zeraatkar, Tyler Stacy Pitre, Sarah Kirsh, Tanvir Jassal, Michael Ling, Muizz Hussain, Rachel J Couban, Leticia Kawano-Dourado, Eirik K Kristianslund, Per Olav Vandvik
{"title":"Proactive therapeutic drug monitoring of biologic drugs in patients with inflammatory bowel disease, inflammatory arthritis, and psoriasis: systematic review and meta-analysis.","authors":"Dena Zeraatkar, Tyler Stacy Pitre, Sarah Kirsh, Tanvir Jassal, Michael Ling, Muizz Hussain, Rachel J Couban, Leticia Kawano-Dourado, Eirik K Kristianslund, Per Olav Vandvik","doi":"10.1136/bmjmed-2024-000998","DOIUrl":"10.1136/bmjmed-2024-000998","url":null,"abstract":"<p><strong>Objective: </strong>To address the efficacy and safety of proactive therapeutic drug monitoring of biologic drugs for patients with inflammatory bowel disease, inflammatory arthritis, and psoriasis.</p><p><strong>Design: </strong>Systematic review and meta-analysis.</p><p><strong>Data sources: </strong>Medline, Embase, Central, and CINAHL, from database inception to 23 May 2024.</p><p><strong>Eligibility criteria for selecting studies: </strong>Trials including people with inflammatory bowel disease, inflammatory arthritis, and psoriasis were selected. Selected trials also randomly assigned people to either proactive therapeutic drug monitoring of tumour necrosis factor-alpha inhibitors or other biologic drugs in the intervention group, and to either no therapeutic drug monitoring or standard care in the control group. Reviewers worked independently and in duplicate to screen search records and collect data from eligible trials. For each outcome, a frequentist, pairwise, random effects meta-analysis was done and the certainty of evidence was assessed using GRADE (grading of recommendations, assessment, development, and evaluations).</p><p><strong>Results: </strong>Of 10 eligible trials identified, reporting on 2383 patients, two investigated induction with infliximab (533 patients), four assessed maintenance with infliximab (901 patients), and three assessed maintenance with adalimumab (710 patients). One trial was of maintenance with infliximab, adalimumab, and etanercept (239 patients). For patients who had induction with infliximab, the effects of proactive therapeutic drug monitoring on remission and adverse events were uncertain. Low certainty evidence suggested that proactive therapeutic drug monitoring may have little or no effect on disease activity, physical function, mental health, and quality of life. For patients who had maintenance with infliximab, low certainty evidence suggested that proactive therapeutic drug monitoring may increase the proportion of patients who had sustained disease control or remission (relative risk 1.26 (95% confidence interval (CI) 1.14 to 1.40), absolute risk difference of 146 more per 1000 patients treated for one year (95% CI 78 to 224). Additionally, this treatment and monitoring may reduce disease worsening, and may have little or no effect on disease activity, physical function, mental health, and quality of life. The effects of proactive therapeutic drug monitoring of infliximab on adverse events and formation of anti-drug antibodies were uncertain. For patients who had maintenance with adalimumab, the effects of proactive therapeutic drug monitoring were uncertain.</p><p><strong>Conclusion: </strong>Proactive therapeutic drug monitoring of infliximab during maintenance may help patients to have sustained disease control or remission. No compelling evidence supported the effectiveness of proactive therapeutic drug monitoring of infliximab during induction or proactive therapeutic drug monit","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000998"},"PeriodicalIF":0.0,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579540/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689865","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}
BMJ medicinePub Date : 2024-10-22eCollection Date: 2024-01-01DOI: 10.1136/bmjmed-2024-000854
Kristýna Faksová, Anna D Laksafoss, Anders Hviid
{"title":"Human papillomavirus nonavalent (HPV9) vaccination and risk of immune mediated diseases, myocarditis, pericarditis, and thromboembolic outcomes in Denmark: self-controlled case series study.","authors":"Kristýna Faksová, Anna D Laksafoss, Anders Hviid","doi":"10.1136/bmjmed-2024-000854","DOIUrl":"10.1136/bmjmed-2024-000854","url":null,"abstract":"<p><strong>Objective: </strong>To assess the associations between vaccination with the nonavalent human papillomavirus (HPV9) vaccine and immune mediated diseases, myocarditis, pericarditis, arterial thromboembolism, and venous thromboembolism with or without thrombocytopenia, in adolescent girls and boys in Denmark.</p><p><strong>Design: </strong>Self-controlled case series study.</p><p><strong>Setting: </strong>Population based study of linked nationwide health registers in Denmark for HPV vaccination and hospital diagnosis data, 1 October 2017 (or age 10 years) to 31 December 2022 or censored. Personal data were obtained from the Central Person Register. Information on dates of HPV vaccination and type of vaccine were obtained from the Danish Vaccination Register. Primary or secondary diagnoses of inpatient or outpatient hospital contact were sourced from the Danish National Patient Register.</p><p><strong>Participants: </strong>Source cohort 854 586. 350 687 individuals aged 10-17 years living in Denmark received at least one dose of HPV9 vaccine. Self-controlled case series analysis of 3354 individuals (1913 girls and 1441 boys) who received at least one dose of HPV9 vaccine and had at least one outcome.</p><p><strong>Main outcome measures: </strong>Rate ratios of the study outcomes in a 28 day or 180 day risk period (depending on the type of outcome) after HPV9 vaccination compared with the reference period were calculated. 47 immune mediated diseases, myocarditis, pericarditis, and seven thromboembolic outcomes were assessed. A safety signal for a specific outcome was identified if at least three outcomes were seen in the risk period after vaccination, the rate ratio was significantly increased (lower bound of the 95% confidence interval (CI) for the self-controlled case series rate ratio >1.0), and the false discovery rate adjusted P value was significant (<0.05).</p><p><strong>Results: </strong>696 776 doses of any HPV vaccine were given during the study period, including 673 530 doses of HPV9 vaccine in 350 687 individuals who received at least one dose. In the self-controlled case series analysis, rate ratios of all immune mediated outcomes combined were 0.99 (95% CI 0.86 to 1.13) and 1.03 (0.89 to 1.20) in girls and boys, respectively, after HPV9 vaccination. Rate ratios for any of the 47 analysed immune mediated outcomes were not increased in the risk periods in girls after vaccination. The only increased rate ratio seen was for Raynaud's disease (rate ratio 2.62, 95% CI 1.07 to 6.40) after HPV9 vaccination in boys, which did not fulfil the criteria of a safety signal. These findings should be interpreted in the light of the study limitations. None of the other 55 outcomes examined showed an association with HPV9 vaccination.</p><p><strong>Conclusions: </strong>The results of this study did not suggest an association between HPV9 vaccination and the study outcomes in adolescent boys and girls aged 10-17 years. This study contributes ","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000854"},"PeriodicalIF":0.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579538/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689863","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}
BMJ medicinePub Date : 2024-10-01eCollection Date: 2024-01-01DOI: 10.1136/bmjmed-2024-001009
Xinyu Zou, Qingyang Shi, Per Olav Vandvik, Yunhe Mao, Arnav Agarwal, Belen Ponte, Xiaoxi Zeng, Gordon Guyatt, Qinbo Yang, Xianghang Luo, Chang Xu, Ping Fu, Haoming Tian, Thomas Agoritsas, Sheyu Li
{"title":"Sodium-glucose co-transporter-2 inhibitors in patients with chronic kidney disease with or without type 2 diabetes: systematic review and meta-analysis.","authors":"Xinyu Zou, Qingyang Shi, Per Olav Vandvik, Yunhe Mao, Arnav Agarwal, Belen Ponte, Xiaoxi Zeng, Gordon Guyatt, Qinbo Yang, Xianghang Luo, Chang Xu, Ping Fu, Haoming Tian, Thomas Agoritsas, Sheyu Li","doi":"10.1136/bmjmed-2024-001009","DOIUrl":"10.1136/bmjmed-2024-001009","url":null,"abstract":"<p><strong>Objective: </strong>To examine cardiovascular and kidney benefits and harms of sodium-glucose co-transporter-2 (SGLT-2) inhibitors stratified by risk in adults with chronic kidney disease regardless of diabetes status.</p><p><strong>Design: </strong>Systematic review and meta-analysis.</p><p><strong>Data sources: </strong>Ovid Medline, Embase, and Cochrane Central from database inception to 15 June 2024.</p><p><strong>Eligibility criteria for selecting studies: </strong>Randomised controlled trials that compared SGLT-2 inhibitors with placebo or standard care with no SGLT-2 inhibitors in adults with chronic kidney disease with a follow-up duration of ≥12 weeks were eligible. Secondary analyses based on subpopulations from randomised controlled trials and publications not in English language were excluded.</p><p><strong>Data synthesis: </strong>Random effects meta-analyses were conducted, with effect estimates presented as risk ratios with 95% confidence intervals (CIs). Absolute treatment effects were estimated over a five year duration for individuals with varied risks of cardiovascular and kidney complications based on the Kidney Disease Improving Global Outcomes (KDIGO) risk stratification system. Certainty of evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach.</p><p><strong>Results: </strong>Evidence from 13 randomised controlled trials (29 614 patients) informed treatment effect estimates. In relative terms, SGLT-2 inhibitors reduced all cause death (risk ratio 0.85 (95% CI 0.74 to 0.98)), cardiovascular death (0.84 (0.74 to 0.96)), kidney failure (0.68 (0.60 to 0.77)), non-fatal stroke (0.73 (0.57 to 0.94)), non-fatal myocardial infarction (0.75 (0.60 to 0.93)), and admission to hospital for heart failure (0.68 (0.60 to 0.78)). No credible subgroup effects were found from diabetes status, heart failure status, estimated glomerular filtration rate, urinary albumin-to-creatinine ratio, and follow-up duration. Absolute effect estimates across these outcomes over a five year period varied across risk groups based on baseline risks of cardiovascular and kidney events. Effects of SGLT-2 inhibitors in the group at low risk included seven fewer all- cause deaths, four fewer admissions to hospital for heart failure per 1000 individuals, and no effects on kidney failure. Effects in the higher risk group included 48 fewer all cause deaths, 58 fewer kidney failures, and 25 fewer admissions to hospital for heart failure per 1000 individuals. Although SGLT-2 inhibitor use was associated with a relative increase in the risk of harms, including genital infection (2.66 (95% CI 2.07 to 3.42)), ketoacidosis (2.27 (1.30 to 3.95)), and symptomatic hypovolaemia (1.29 (1.15 to 1.44)), absolute differences for all harm outcomes were small.</p><p><strong>Conclusions: </strong>Among people who have chronic kidney disease either with type 2 diabetes or not, SGLT-2 inhibitors improved cardiov","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e001009"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579537/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689867","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}
BMJ medicinePub Date : 2024-09-16eCollection Date: 2024-01-01DOI: 10.1136/bmjmed-2023-000743
Sarah C J Jorgensen, Samantha S M Drover, Deshayne B Fell, Peter C Austin, Rohan D'Souza, Astrid Guttmann, Sarah A Buchan, Sarah E Wilson, Sharifa Nasreen, Kevin A Brown, Kevin L Schwartz, Mina Tadrous, Kumanan Wilson, Jeffrey C Kwong
{"title":"Association between maternal mRNA covid-19 vaccination in early pregnancy and major congenital anomalies in offspring: population based cohort study with sibling matched analysis.","authors":"Sarah C J Jorgensen, Samantha S M Drover, Deshayne B Fell, Peter C Austin, Rohan D'Souza, Astrid Guttmann, Sarah A Buchan, Sarah E Wilson, Sharifa Nasreen, Kevin A Brown, Kevin L Schwartz, Mina Tadrous, Kumanan Wilson, Jeffrey C Kwong","doi":"10.1136/bmjmed-2023-000743","DOIUrl":"10.1136/bmjmed-2023-000743","url":null,"abstract":"<p><strong>Objective: </strong>To examine the association between maternal mRNA covid-19 vaccination during the first trimester of pregnancy and the prevalence of major congenital anomalies in offspring.</p><p><strong>Design: </strong>Population based cohort study with sibling matched analysis.</p><p><strong>Setting: </strong>Multiple health administrative databases, linked and analysed at ICES, an independent, non-profit research institute that collects and analyses healthcare and demographic data, Ontario, Canada, from 16 October 2021 to 1 May 2023.</p><p><strong>Population: </strong>174 296 singleton live births >20 weeks' gestation with an expected birth date between 16 October 2021 and 1 May 2023: 34 181 (20%) born to mothers who received one or two doses of an mRNA covid-19 vaccine in the first trimester and 34 951 (20%) born to mothers who did not receive a vaccine before or during pregnancy. The sibling matched analysis included 13 312 infants exposed to a covid-19 vaccine in the first trimester and 15 089 matched older siblings with the same mother, with an expected birth date after 16 October 2016 and no reported in utero exposure to a covid-19 vaccine.</p><p><strong>Main outcome measures: </strong>Major congenital anomalies, overall and grouped by specific organ systems, diagnosed within 28 days of birth.</p><p><strong>Results: </strong>Major congenital anomalies were present in 832 (24.3 per 1000 live births) infants exposed to an mRNA covid-19 vaccine in the first trimester compared with 927 (26.5 per 1000 live births) infants not exposed to a vaccine, resulting in an adjusted prevalence ratio of 0.89 (95% confidence interval (CI) 0.79 to 1.01). Major congenital anomalies were present in 283 (21.3 per 1000 live births) and 343 (22.7 per 1000 live births) infants exposed to an mRNA covid-19 vaccine in the first trimester and their older siblings not exposed to a vaccine, respectively (adjusted prevalence ratio 0.91, 95% CI 0.77 to 1.07). First trimester vaccination was not associated with an increase in major congenital anomalies grouped by specific organ system in the primary or sibling matched analyses. Results were similar across a range of subgroup and sensitivity analyses.</p><p><strong>Conclusions: </strong>In this large population based cohort study and sibling matched analysis, mRNA covid-19 vaccination during the first trimester of pregnancy was not associated with an increase in major congenital anomalies in offspring, overall or grouped by organ system.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000743"},"PeriodicalIF":0.0,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579536/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689860","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":"Progressive pulmonary fibrosis: a need for real world data to solve real world clinical problems.","authors":"Huajian Liu, Kerri-Marie Heenan, Liam Coyle, Nazia Chaudhuri","doi":"10.1136/bmjmed-2024-000911","DOIUrl":"10.1136/bmjmed-2024-000911","url":null,"abstract":"","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000911"},"PeriodicalIF":0.0,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11340238/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142037903","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}