Ovidio De Filippo, Francesco Piroli, Francesco Bruno, Pier Paolo Bocchino, Andrea Saglietto, Luca Franchin, Filippo Angelini, Guglielmo Gallone, Giulia Rizzello, Mahmood Ahmad, Mauro Gasparini, Saurav Chatterjee, Gaetano Maria De Ferrari, Fabrizio D'Ascenzo
{"title":"De-escalation of dual antiplatelet therapy for patients with acute coronary syndrome after percutaneous coronary intervention: a systematic review and network meta-analysis.","authors":"Ovidio De Filippo, Francesco Piroli, Francesco Bruno, Pier Paolo Bocchino, Andrea Saglietto, Luca Franchin, Filippo Angelini, Guglielmo Gallone, Giulia Rizzello, Mahmood Ahmad, Mauro Gasparini, Saurav Chatterjee, Gaetano Maria De Ferrari, Fabrizio D'Ascenzo","doi":"10.1136/bmjebm-2023-112476","DOIUrl":"10.1136/bmjebm-2023-112476","url":null,"abstract":"<p><strong>Objectives: </strong>To compare dual antiplatelet therapy (DAPT) de-escalation with five alternative DAPT strategies in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).</p><p><strong>Design: </strong>We conducted a systematic review and network meta-analysis (NMA). Parallel-arm randomised controlled trials (RCTs) comparing DAPT strategies were included and arms of interest were compared via NMA. Partial ranking of each identified arm and for each investigated endpoint was also performed.</p><p><strong>Setting and participants: </strong>Adult patients with ACS (≥18 years) undergoing PCI with indications for DAPT.</p><p><strong>Search methods: </strong>A comprehensive search covered several databases (PubMed, Embase, Cochrane Central, MEDLINE, Conference Proceeding Citation Index-Science) from inception to 15 October 2023. Medical subject headings and keywords related to ACS, PCI and DAPT interventions were used. Reference lists of included studies were screened. Clinical trials registers were searched for ongoing or unpublished trials.</p><p><strong>Interventions: </strong>Six strategies were assessed: T1 arm: acetylsalicylic acid (ASA) and prasugrel for 12 months; T2 arm: ASA and low-dose prasugrel for 12 months; T3 arm: ASA and ticagrelor for 12 months; T4 arm: DAPT de-escalation (ASA+P2Y12 inhibitor for 1-3 months, then single antiplatelet therapy with potent P2Y12 inhibitor or DAPT with clopidogrel); T5 arm: ASA and clopidogrel for 12 months; T6 arm: ASA and clopidogrel for 3-6 months.</p><p><strong>Main outcome measures: </strong>Primary outcome: Cardiovascular mortality.</p><p><strong>Secondary outcomes: </strong>bleeding events (all, major, minor), stent thrombosis (ST), stroke, myocardial infarction (MI), all-cause mortality, major adverse cardiovascular events (MACE).</p><p><strong>Results: </strong>23 RCTs (75 064 patients with ACS) were included. No differences in cardiovascular mortality, all-cause death, recurrent MI or MACE were found when the six strategies were compared, although with different levels of certainty of evidence. ASA and clopidogrel for 12 or 3-6 months may result in a large increase of ST risk versus ASA plus full-dose prasugrel (OR 2.00, 95% CI 1.14 to 3.12, and OR 3.42, 95% CI 1.33 to 7.26, respectively; low certainty evidence for both comparisons). DAPT de-escalation probably results in a reduced risk of all bleedings compared with ASA plus full-dose 12-month prasugrel (OR 0.49, 95% CI 0.26 to 0.81, moderate-certainty evidence) and ASA plus 12-month ticagrelor (OR 0.52, 95% CI 0.33 to 0.75), while it may not increase the risk of ST. ASA plus 12-month clopidogrel may reduce all bleedings versus ASA plus full-dose 12-month prasugrel (OR 0.66, 95% CI 0.42 to 0.94, low certainty) and ASA plus 12-month ticagrelor (OR 0.70, 95% CI 0.52 to 0.89).</p><p><strong>Conclusions: </strong>DAPT de-escalation and ASA-clopidogrel regimens may reduce bleeding events compare","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"171-186"},"PeriodicalIF":5.8,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139502200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy of non-pharmacological interventions for primary dysmenorrhoea: a systematic review and Bayesian network meta-analysis.","authors":"Xinglin Li, Xinyu Hao, Jian-Hua Liu, Jian-Peng Huang","doi":"10.1136/bmjebm-2023-112434","DOIUrl":"10.1136/bmjebm-2023-112434","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the relative benefits of various non-pharmacological interventions on treating primary dysmenorrhoea within a network meta-analysis.</p><p><strong>Study design: </strong>Systematic review and Bayesian network meta-analysis.</p><p><strong>Inclusion criteria: </strong>Randomised controlled trial involving patient with primary dysmenorrhoea and received non-pharmacological interventions.</p><p><strong>Data sources: </strong>Four databases (Medline, Embase, Cochrane Library and Web of Science) were searched from inception to October first, 2022.</p><p><strong>Risk-of-bias rob assessment: </strong>RoB 2.0 assessment tools was used to assess the risk of bias in the included studies.</p><p><strong>Synthesis of results: </strong>Conventional meta-analysis was conducted by pairwise comparison between non-pharmacological therapy and control treatment. The Bayesian network meta-analysis was conducted by the Aggregate Data Drug Information System Software based on the consistency or inconsistency model, and rank probability was used to indicate the priority of non-pharmacological therapy.</p><p><strong>Results: </strong>33 studies involving eight non-pharmacological interventions were included. With regard to conventional meta-analysis, we selected Visual Analogue Scale (VAS) as primary outcome to evaluate the pain intensity. The result showed that eight interventions (Exercise, Herb, Acupuncture, Aromatherapy, Transcutaneous Electrical Nerve Stimulation, Topical heat, Acupressure, Yoga) displayed positive effect on reduction of menstrual pain compared with placebo or no treatment. A Bayesian network meta-analysis revealed that exercise -3.20 (95% CI -4.01 to -2.34), acupuncture -2.90 (95% CI -3.97 to -2.85) and topical heat -2.97 (95% CI -4.66 to -1.29) probably resulted in a reduction in pain intensity (VAS) .</p><p><strong>Conclusions: </strong>Non-pharmacological interventions may result in a reduction or slight reduction in pain intensity compared with no treatment or placebo. Specifically, exercise and acupuncture are considered as potentially effective non-pharmacological treatments in short-term treatment. Indeed, larger and better methodological quality research is needed.</p><p><strong>Trial registration number: </strong>CRD42022351021.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"162-170"},"PeriodicalIF":5.8,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11137453/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139502238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"How to use the regulatory data from Health Canada for secondary analyses on new drugs, biologics and vaccines.","authors":"Isaac Bai, Peter Doshi, Matthew Herder","doi":"10.1136/bmjebm-2023-112475","DOIUrl":"10.1136/bmjebm-2023-112475","url":null,"abstract":"<p><p>Incorporating clinical data held by national health product regulatory authorities into secondary analyses such as systematic reviews can help combat publication bias and selective outcome reporting, in turn, supporting more evidence-based decisions regarding the prescribing of drugs, biologics and vaccines. Owing to recent changes in Canadian law, Health Canada has begun to make clinical information-whether it has been previously published or not-publicly available through its 'Public Release of Clinical Information' (PRCI) online database. We provide guidance about how to access and use regulatory data obtained through the PRCI database for the purpose of conducting drug and biologic secondary analyses.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"187-193"},"PeriodicalIF":5.8,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11137451/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66783567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Equity of access to healthcare for a patient with a severe intellectual disability.","authors":"","doi":"10.1136/bmjebm-2024-112866","DOIUrl":"10.1136/bmjebm-2024-112866","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"207-208"},"PeriodicalIF":5.8,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139740360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"How methodological pitfalls have created widespread misunderstanding about long COVID.","authors":"Tracy Beth Høeg, Shamez Ladhani, Vinay Prasad","doi":"10.1136/bmjebm-2023-112338","DOIUrl":"10.1136/bmjebm-2023-112338","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"142-146"},"PeriodicalIF":5.8,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11137465/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41118258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Potential impact of large language models on academic writing.","authors":"Fares Alahdab","doi":"10.1136/bmjebm-2023-112429","DOIUrl":"10.1136/bmjebm-2023-112429","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"201-202"},"PeriodicalIF":5.8,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10123561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Adewole S Adamson, Geetanjali Naik, Mark A Jones, Katy Jl Bell
{"title":"Ecological study estimating melanoma overdiagnosis in the USA using the lifetime risk method.","authors":"Adewole S Adamson, Geetanjali Naik, Mark A Jones, Katy Jl Bell","doi":"10.1136/bmjebm-2023-112460","DOIUrl":"10.1136/bmjebm-2023-112460","url":null,"abstract":"<p><strong>Objectives: </strong>To quantify the proportion of melanoma diagnoses (invasive and in situ) in the USA that might be overdiagnosed.</p><p><strong>Design: </strong>In this ecological study, incidence and mortality data were collected from the Surveillance, Epidemiology and End Results 9 registries database. DevCan software was used to calculate the cumulative lifetime risk of being diagnosed with melanoma between 1975 and 2018, with adjustments made for changes in longevity and risk factors over the study period.</p><p><strong>Setting: </strong>USA.</p><p><strong>Participants: </strong>White American men and women (1975-2018).</p><p><strong>Main outcome measures: </strong>The primary outcome was excess lifetime risk of melanoma diagnosis between 1976 and 2018 (adjusted for year 2018 competing mortality and changes in risk factors), which was inferred as likely overdiagnosis. The secondary outcome was an excess lifetime risk of melanoma diagnosis in each year between 1976 and 2018 (adjusted and unadjusted).</p><p><strong>Results: </strong>Between 1975 and 2018 the adjusted lifetime risk of being diagnosed with melanoma (invasive and in situ) increased from 3.2% (1 in 31) to 6.4% (1 in 16) among white men, and from 1.6% (1 in 63) to 4.5% (1 in 22) among white women. Over the same period, the adjusted lifetime risk of being diagnosed with melanoma in situ increased from 0.17% (1 in 588) to 2.7% (1 in 37) in white men and 0.08% (1 in 1250) to 2.0% (1 in 50) in white women. An estimated 49.7% of melanomas diagnosed in white men and 64.6% in white women were overdiagnosed in 2018. Among people diagnosed with melanomas in situ, 89.4% of white men and 85.4% of white women were likely overdiagnosed in 2018.</p><p><strong>Conclusions: </strong>Melanoma overdiagnosis among white Americans is significant and increasing over time with an estimated 44 000 overdiagnosed in men and 39 000 in women in 2018. A large proportion of overdiagnosed melanomas are in situ cancers, pointing to a potential focus for intervention.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"156-161"},"PeriodicalIF":5.8,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139502233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Overly complex methods may impair pragmatic use of core evidence-based medicine principles.","authors":"Rebecca Kuehn, Ying Wang, Gordon Guyatt","doi":"10.1136/bmjebm-2024-112868","DOIUrl":"10.1136/bmjebm-2024-112868","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"139-141"},"PeriodicalIF":9.0,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140058653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sitanshu Sekhar Kar, Parthibane Sivanantham, Vanessa Ravel, Abha Mehndiratta, Kirti Tyagi, Daniel A Ollendorf
{"title":"Cost-effectiveness of emicizumab prophylaxis for haemophilia A with inhibitors: an adaptive health technology assessment for the Indian setting","authors":"Sitanshu Sekhar Kar, Parthibane Sivanantham, Vanessa Ravel, Abha Mehndiratta, Kirti Tyagi, Daniel A Ollendorf","doi":"10.1136/bmjebm-2023-112492","DOIUrl":"https://doi.org/10.1136/bmjebm-2023-112492","url":null,"abstract":"Objective To assess the cost-effectiveness of emicizumab prophylaxis for patients having haemophilia A with inhibitors in the Indian context using an adaptive health technology assessment (aHTA) methodology. Design Economic evaluation using multiple approaches aimed at adjusting previously generated cost-effectiveness results based on (1) price differences only (‘simple’) and (2) differences in cost and expected treatment duration (‘moderate’) and differences in cost, inflation and life expectancy (‘complex’). Setting Typical haemophilia care in India. Participants Patients with haemophilia A and inhibitors. Intervention Emicizumab prophylaxis using two vial strengths (30 or 150 mg/mL) in comparison to no prophylaxis. Main outcome measures Adjusted incremental cost-effectiveness ratio (ICERa), incremental costs and incremental quality-adjusted life years associated with emicizumab prophylaxis from both the health system and societal perspectives. Results Using the simple ICER adjustment method, emicizumab prophylaxis resulted in potential cost savings from the payers’ perspective for both vial strengths in patients aged ≥12 and <12 years. However, from a societal perspective, emicizumab prophylaxis was not cost-effective. Using the moderate adjustment method, emicizumab prophylaxis showed potential cost saving from the health system perspective. The complex adjustment method also revealed cost savings for emicizumab prophylaxis from the health system and societal perspectives across different age groups. Conclusion We found that implementing emicizumab prophylaxis for patients with haemophilia A and inhibitors in India has the potential to result in cost savings. This study highlights the feasibility of using the expanded aHTA methodology for rapid evidence generation in the Indian context. However, it is crucial to address certain research gaps, including data limitations, challenges in translating international evidence to Indian context and associated uncertainties. Additionally, conducting a comprehensive budget impact analysis is necessary. These findings hold significant implications for decision-making regarding the potential provision of emicizumab prophylaxis through federal or/and state government-funded programmes and institutions in India. Data are available upon reasonable request. Data are available upon reasonable request to the corresponding author.","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":"62 1","pages":""},"PeriodicalIF":5.8,"publicationDate":"2024-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140883738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Celeste McCracken, Zahra Raisi-Estabragh, Liliana Szabo, Michele Veldsman, Betty Raman, Anya Topiwala, Adriana Roca-Fernández, Masud Husain, Steffen E Petersen, Stefan Neubauer, Thomas E Nichols
{"title":"Feasibility of multiorgan risk prediction with routinely collected diagnostics: a prospective cohort study in the UK Biobank","authors":"Celeste McCracken, Zahra Raisi-Estabragh, Liliana Szabo, Michele Veldsman, Betty Raman, Anya Topiwala, Adriana Roca-Fernández, Masud Husain, Steffen E Petersen, Stefan Neubauer, Thomas E Nichols","doi":"10.1136/bmjebm-2023-112518","DOIUrl":"https://doi.org/10.1136/bmjebm-2023-112518","url":null,"abstract":"Objectives Despite rising rates of multimorbidity, existing risk assessment tools are mostly limited to a single outcome of interest. This study tests the feasibility of producing multiple disease risk estimates with at least 70% discrimination (area under the receiver operating curve, AUROC) within the time and information constraints of the existing primary care health check framework. Design Observational prospective cohort study Setting UK Biobank. Participants 228 240 adults from the UK population. Interventions None. Main outcome measures Myocardial infarction, atrial fibrillation, heart failure, stroke, all-cause dementia, chronic kidney disease, fatty liver disease, alcoholic liver disease, liver cirrhosis and liver failure. Results Using a set of predictors easily gathered at the standard primary care health check (such as the National Health Service Health Check), we demonstrate that it is feasible to simultaneously produce risk estimates for multiple disease outcomes with AUROC of 70% or greater. These predictors can be entered once into a single form and produce risk scores for stroke (AUROC 0.727, 95% CI 0.713 to 0.740), all-cause dementia (0.823, 95% CI 0.810 to 0.836), myocardial infarction (0.785, 95% CI 0.775 to 0.795), atrial fibrillation (0.777, 95% CI 0.768 to 0.785), heart failure (0.828, 95% CI 0.818 to 0.838), chronic kidney disease (0.774, 95% CI 0.765 to 0.783), fatty liver disease (0.766, 95% CI 0.753 to 0.779), alcoholic liver disease (0.864, 95% CI 0.835 to 0.894), liver cirrhosis (0.763, 95% CI 0.734 to 0.793) and liver failure (0.746, 95% CI 0.695 to 0.796). Conclusions Easily collected diagnostics can be used to assess 10-year risk across multiple disease outcomes, without the need for specialist computing or invasive biomarkers. Such an approach could increase the utility of existing data and place multiorgan risk information at the fingertips of primary care providers, thus creating opportunities for longer-term multimorbidity prevention. Additional work is needed to validate whether these findings would hold in a larger, more representative cohort outside the UK Biobank. Data may be obtained from a third party and are not publicly available. This analysis was produced under UK Biobank Access Application 59867. The data in this study are owned by the UK Biobank (www. ukbiobank.ac.uk) and legal constraints do not permit public sharing of the data. The UK Biobank, however, is open to all bona fide researchers anywhere in the world. Thus, the data used in this communication can be easily and directly accessed by applying through the UK Biobank Access Management System (www.ukbiobank.ac.uk/ register-apply). Results from this study will be returned to UK Biobank according to their published returns policy.","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":"21 1","pages":""},"PeriodicalIF":5.8,"publicationDate":"2024-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140883781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}