Pub Date : 2017-04-01Epub Date: 2017-03-08DOI: 10.1136/ebmed-2017-110685
Denise Campbell-Scherer
The 2008 Food and Drug Administration (FDA) guidance to industry requires experimental evidence that new agents to treat type 2 diabetes do not have an unacceptable increase in cardiovascular risk. They specify this unacceptable increase to be a risk ratio of 1.3 in non-inferiority trials which may use placebo control. Clinically, this means that if a new agent achieves this threshold of not being 30% worse than placebo it is declared 'non-inferior'. This guidance was in response to safety concerns raised about medications approved on their basis of reducing glycated haemoglobin alone. There was concern that this FDA guidance would stifle new drugs coming to market. On the contrary, there have been a number of exciting new classes of agents approved with improved confidence that they reduce glycated haemoglobin, and that they also do not excessively increase cardiovascular risk. Cardiovascular safety trials have been conducted for a number of novel medications using a non-inferiority approach. However, clinicians need to recognise that the results of non-inferiority trials are not as credible as superiority trials. It is important to closely review the trials before accepting claims of 'non-inferiority' or 'cardiac neutrality' especially when these studies are often compared with placebo, and may be accepting estimates of effect which span potentially clinically meaningful harm. There are compelling reasons to further investigate agents showing promise in non-inferiority trials with superiority trials, which include prespecified subgroups, and with sufficient power and duration to provide robust estimates of harms and benefits to inform clinical decision-making.
{"title":"Reflections on using non-inferiority randomised placebo controlled trials in assessing cardiovascular safety of new agents for treatment of type 2 diabetes.","authors":"Denise Campbell-Scherer","doi":"10.1136/ebmed-2017-110685","DOIUrl":"https://doi.org/10.1136/ebmed-2017-110685","url":null,"abstract":"<p><p>The 2008 Food and Drug Administration (FDA) guidance to industry requires experimental evidence that new agents to treat type 2 diabetes do not have an unacceptable increase in cardiovascular risk. They specify this unacceptable increase to be a risk ratio of 1.3 in non-inferiority trials which may use placebo control. Clinically, this means that if a new agent achieves this threshold of not being 30% worse than placebo it is declared 'non-inferior'. This guidance was in response to safety concerns raised about medications approved on their basis of reducing glycated haemoglobin alone. There was concern that this FDA guidance would stifle new drugs coming to market. On the contrary, there have been a number of exciting new classes of agents approved with improved confidence that they reduce glycated haemoglobin, and that they also do not excessively increase cardiovascular risk. Cardiovascular safety trials have been conducted for a number of novel medications using a non-inferiority approach. However, clinicians need to recognise that the results of non-inferiority trials are not as credible as superiority trials. It is important to closely review the trials before accepting claims of 'non-inferiority' or 'cardiac neutrality' especially when these studies are often compared with placebo, and may be accepting estimates of effect which span potentially clinically meaningful harm. There are compelling reasons to further investigate agents showing promise in non-inferiority trials with superiority trials, which include prespecified subgroups, and with sufficient power and duration to provide robust estimates of harms and benefits to inform clinical decision-making.</p>","PeriodicalId":12182,"journal":{"name":"Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/ebmed-2017-110685","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34795968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Commentary on: Lasa JJ, Rogers RS, Localio R, et al. Extracorporeal Cardiopulmonary Resuscitation (E-CPR) During pediatric in-hospital cardiopulmonary arrest is associated with improved survival to discharge: a report from the American Heart Association's Get With The Guidelines-Resuscitation (GWTG-R) registry. Circulation 2016;133:165–76[OpenUrl][1][Abstract/FREE Full Text][2]. Data from national and international paediatric databases indicate that the use of extracorporeal cardiopulmonary resuscitation (E-CPR) is increasing.1 Considering the significant resources and cost involved in the use of E-CPR, its use needs to be critically examined to optimise outcomes. This large, multicentre study compared conventional cardiopulmonary resuscitation (C-CPR) and (E-CPR) in paediatric in-hospital cardiac arrest (IHCA). This is a retrospective multicentre cohort study that used data from the American Heart Association Get with the Guidelines Registry. The study included all children (<18 years of age) who had an IHCA and received CPR for ≥10 min between 1 January 2000 and 31 December, 2011. Patients from hospitals with no E-CPR cases, obstetric and trauma diagnosis, missing E-CPR or survival information and … [1]: {openurl}?query=rft.jtitle%253DCirculation%26rft_id%253Dinfo%253Adoi%252F10.1161%252FCIRCULATIONAHA.115.016082%26rft_id%253Dinfo%253Apmid%252F26635402%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/ijlink?linkType=ABST&journalCode=circulationaha&resid=133/2/165&atom=%2Febmed%2F21%2F6%2F227.atom
{"title":"Compared to conventional CPR for in-hospital cardiac arrest, extracorporeal-CPR is associated with improved survival to hospital discharge and more favourable neurological outcome.","authors":"Lindsay Ryerson, Gonzalo Garcia Guerra, Laurance Lequier","doi":"10.1136/ebmed-2016-110467","DOIUrl":"https://doi.org/10.1136/ebmed-2016-110467","url":null,"abstract":"Commentary on: Lasa JJ, Rogers RS, Localio R, et al. Extracorporeal Cardiopulmonary Resuscitation (E-CPR) During pediatric in-hospital cardiopulmonary arrest is associated with improved survival to discharge: a report from the American Heart Association's Get With The Guidelines-Resuscitation (GWTG-R) registry. Circulation 2016;133:165–76[OpenUrl][1][Abstract/FREE Full Text][2].\u0000\u0000Data from national and international paediatric databases indicate that the use of extracorporeal cardiopulmonary resuscitation (E-CPR) is increasing.1 Considering the significant resources and cost involved in the use of E-CPR, its use needs to be critically examined to optimise outcomes. This large, multicentre study compared conventional cardiopulmonary resuscitation (C-CPR) and (E-CPR) in paediatric in-hospital cardiac arrest (IHCA).\u0000\u0000This is a retrospective multicentre cohort study that used data from the American Heart Association Get with the Guidelines Registry. The study included all children (<18 years of age) who had an IHCA and received CPR for ≥10 min between 1 January 2000 and 31 December, 2011. Patients from hospitals with no E-CPR cases, obstetric and trauma diagnosis, missing E-CPR or survival information and …\u0000\u0000 [1]: {openurl}?query=rft.jtitle%253DCirculation%26rft_id%253Dinfo%253Adoi%252F10.1161%252FCIRCULATIONAHA.115.016082%26rft_id%253Dinfo%253Apmid%252F26635402%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx\u0000 [2]: /lookup/ijlink?linkType=ABST&journalCode=circulationaha&resid=133/2/165&atom=%2Febmed%2F21%2F6%2F227.atom","PeriodicalId":12182,"journal":{"name":"Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/ebmed-2016-110467","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34356299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-12-01Epub Date: 2016-09-06DOI: 10.1136/ebmed-2015-110361
Martin Than
Commentary on: Fanaroff AC, Rymer JA, Goldstein SA, et al. Does this patient with chest pain have acute coronary syndrome? The rational clinical examination systematic review. JAMA 2015;314:1955–65[OpenUrl][1][CrossRef][2][PubMed][3]. Up to 5–10% of annual presentations to emergency departments (EDs) and 25% of hospital admissions are patients with symptoms suggestive of acute coronary syndromes (ACS). Estimating the pretest probability of ACS is important. Traditionally, this has been determined using clinical acumen, primarily involving historical variables and risk factors learnt during early training and reinforced in clinical practice. This systematic review assessed diagnostic utility of the history, physical examination and ECG to increase or decrease the estimated likelihood of ACS. It also assessed the accuracy of decision aids (risk scores) in combination with the initial ECG and troponin level. Studies included in this systematic review had to (1) involve patients presenting to an ED with suspected … [1]: {openurl}?query=rft.jtitle%253DJAMA%26rft.volume%253D314%26rft.spage%253D1955%26rft_id%253Dinfo%253Adoi%252F10.1001%252Fjama.2015.12735%26rft_id%253Dinfo%253Apmid%252F26547467%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1001/jama.2015.12735&link_type=DOI [3]: /lookup/external-ref?access_num=26547467&link_type=MED&atom=%2Febmed%2F21%2F6%2F236.atom
{"title":"Traditionally taught clinical variables and risk factors perform poorly in the prediction of acute coronary syndromes in the emergency department.","authors":"Martin Than","doi":"10.1136/ebmed-2015-110361","DOIUrl":"https://doi.org/10.1136/ebmed-2015-110361","url":null,"abstract":"Commentary on: Fanaroff AC, Rymer JA, Goldstein SA, et al. Does this patient with chest pain have acute coronary syndrome? The rational clinical examination systematic review. JAMA 2015;314:1955–65[OpenUrl][1][CrossRef][2][PubMed][3].\u0000\u0000Up to 5–10% of annual presentations to emergency departments (EDs) and 25% of hospital admissions are patients with symptoms suggestive of acute coronary syndromes (ACS). Estimating the pretest probability of ACS is important. Traditionally, this has been determined using clinical acumen, primarily involving historical variables and risk factors learnt during early training and reinforced in clinical practice. This systematic review assessed diagnostic utility of the history, physical examination and ECG to increase or decrease the estimated likelihood of ACS. It also assessed the accuracy of decision aids (risk scores) in combination with the initial ECG and troponin level.\u0000\u0000Studies included in this systematic review had to (1) involve patients presenting to an ED with suspected …\u0000\u0000 [1]: {openurl}?query=rft.jtitle%253DJAMA%26rft.volume%253D314%26rft.spage%253D1955%26rft_id%253Dinfo%253Adoi%252F10.1001%252Fjama.2015.12735%26rft_id%253Dinfo%253Apmid%252F26547467%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx\u0000 [2]: /lookup/external-ref?access_num=10.1001/jama.2015.12735&link_type=DOI\u0000 [3]: /lookup/external-ref?access_num=26547467&link_type=MED&atom=%2Febmed%2F21%2F6%2F236.atom","PeriodicalId":12182,"journal":{"name":"Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/ebmed-2015-110361","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34421241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-10-01Epub Date: 2016-08-31DOI: 10.1136/ebmed-2016-110496
Simon Endes
Commentary on: Soares-Miranda L, Siscovick DS, Psaty BM, et al. Physical activity and risk of coronary heart disease and stroke in older adults: the cardiovascular health study. Circulation 2016;133:147–55[OpenUrl][1][Abstract/FREE Full Text][2]. Currently, at least 150 min per week of moderate-to-vigorous physical activity is recommended for adults of all ages to beneficially influence individual and population health and cardiovascular mortality.1 Adhering to current physical activity guidelines has been shown to be associated with a 20% lower mortality risk compared to physically inactive persons.2 A physically active lifestyle is linked with decreased risk of cardiovascular disease (CVD) and CVD events, such as myocardial infarction or stroke, at all ages, and in some improvements in atherosclerotic processes and stiffening of the arteries.3–6 Walking is a low-risk activity and … [1]: {openurl}?query=rft.jtitle%253DCirculation%26rft_id%253Dinfo%253Adoi%252F10.1161%252FCIRCULATIONAHA.115.018323%26rft_id%253Dinfo%253Apmid%252F26538582%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/ijlink?linkType=ABST&journalCode=circulationaha&resid=133/2/147&atom=%2Febmed%2F21%2F5%2F191.atom
{"title":"Physical activity reduces cardiovascular disease risk in older adults.","authors":"Simon Endes","doi":"10.1136/ebmed-2016-110496","DOIUrl":"https://doi.org/10.1136/ebmed-2016-110496","url":null,"abstract":"Commentary on: Soares-Miranda L, Siscovick DS, Psaty BM, et al. Physical activity and risk of coronary heart disease and stroke in older adults: the cardiovascular health study. Circulation 2016;133:147–55[OpenUrl][1][Abstract/FREE Full Text][2].\u0000\u0000Currently, at least 150 min per week of moderate-to-vigorous physical activity is recommended for adults of all ages to beneficially influence individual and population health and cardiovascular mortality.1 Adhering to current physical activity guidelines has been shown to be associated with a 20% lower mortality risk compared to physically inactive persons.2 A physically active lifestyle is linked with decreased risk of cardiovascular disease (CVD) and CVD events, such as myocardial infarction or stroke, at all ages, and in some improvements in atherosclerotic processes and stiffening of the arteries.3–6 Walking is a low-risk activity and …\u0000\u0000 [1]: {openurl}?query=rft.jtitle%253DCirculation%26rft_id%253Dinfo%253Adoi%252F10.1161%252FCIRCULATIONAHA.115.018323%26rft_id%253Dinfo%253Apmid%252F26538582%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx\u0000 [2]: /lookup/ijlink?linkType=ABST&journalCode=circulationaha&resid=133/2/147&atom=%2Febmed%2F21%2F5%2F191.atom","PeriodicalId":12182,"journal":{"name":"Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/ebmed-2016-110496","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34351771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-10-01Epub Date: 2016-08-12DOI: 10.1136/ebmed-2016-110419
Jean François Dartigues, Catherine Helmer
Commentary on: Walters K, Hardoon S, Petersen I, et al. Predicting dementia risk in primary care: development and validation of the Dementia Risk Score using routinely collected data. BMC Medicine 2016;14:6[OpenUrl][1][CrossRef][2][PubMed][3]. In spite of major repercussions on the life of patients and caregivers, dementia remains a neglected domain in primary care setting. Previous studies have shown that only a third of new dementia cases occurring in the general population were referred to a specialist1 and that too at a severe stage of the disease, 25% of cases were ignored.2 A great proportion of primary care practitioners (PCPs) consider dementia to be an irreversible consequence of brain ageing. However, PCPs are pragmatic, and if a simple predicting score based on … [1]: {openurl}?query=rft.jtitle%253DBMC%2BMedicine%26rft.volume%253D14%26rft.spage%253D6%26rft_id%253Dinfo%253Adoi%252F10.1186%252Fs12916-016-0549-y%26rft_id%253Dinfo%253Apmid%252F26797096%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1186/s12916-016-0549-y&link_type=DOI [3]: /lookup/external-ref?access_num=26797096&link_type=MED&atom=%2Febmed%2F21%2F5%2F198.atom
{"title":"Risk score developed from routinely collected data by primary healthcare practitioners is useful to rule out dementia in 60-79 year-olds.","authors":"Jean François Dartigues, Catherine Helmer","doi":"10.1136/ebmed-2016-110419","DOIUrl":"https://doi.org/10.1136/ebmed-2016-110419","url":null,"abstract":"Commentary on: Walters K, Hardoon S, Petersen I, et al. Predicting dementia risk in primary care: development and validation of the Dementia Risk Score using routinely collected data. BMC Medicine 2016;14:6[OpenUrl][1][CrossRef][2][PubMed][3].\u0000\u0000In spite of major repercussions on the life of patients and caregivers, dementia remains a neglected domain in primary care setting. Previous studies have shown that only a third of new dementia cases occurring in the general population were referred to a specialist1 and that too at a severe stage of the disease, 25% of cases were ignored.2 A great proportion of primary care practitioners (PCPs) consider dementia to be an irreversible consequence of brain ageing. However, PCPs are pragmatic, and if a simple predicting score based on …\u0000\u0000 [1]: {openurl}?query=rft.jtitle%253DBMC%2BMedicine%26rft.volume%253D14%26rft.spage%253D6%26rft_id%253Dinfo%253Adoi%252F10.1186%252Fs12916-016-0549-y%26rft_id%253Dinfo%253Apmid%252F26797096%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx\u0000 [2]: /lookup/external-ref?access_num=10.1186/s12916-016-0549-y&link_type=DOI\u0000 [3]: /lookup/external-ref?access_num=26797096&link_type=MED&atom=%2Febmed%2F21%2F5%2F198.atom","PeriodicalId":12182,"journal":{"name":"Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/ebmed-2016-110419","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34659522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-10-01Epub Date: 2016-08-23DOI: 10.1136/ebmed-2016-110501
Charlotte Suppli Ulrik
Commentary on : Woodruff PG, Barr RG, Bleecker E, et al. Clinical significance of symptoms in smokers with preserved pulmonary function. N Engl J Med 2016;374:1811–21.[OpenUrl][1][CrossRef][2][PubMed][3] COPD is, according to the Global Initiative for Chronic Obstructive Lung Disease, defined as persistent airflow limitation, that is, the key diagnostic criterion is a postbronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio <0.70.1 However, this definition has clear limitations in clinical practice, as it does not take symptoms into account and only applies to individuals in whom fixed airflow limitation has developed.2 Furthermore, this diagnostic criterion, that is, FEV1/FVC ratio <0.70, is likely to be insensitive for recognition of early COPD.3 ,4 Some current or … [1]: {openurl}?query=rft.jtitle%253DN%2BEngl%2BJ%2BMed%26rft.volume%253D374%26rft.spage%253D1811%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMoa1505971%26rft_id%253Dinfo%253Apmid%252F27168432%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1056/NEJMoa1505971&link_type=DOI [3]: /lookup/external-ref?access_num=27168432&link_type=MED&atom=%2Febmed%2Fearly%2F2016%2F08%2F23%2Febmed-2016-110501.atom
{"title":"Smokers with respiratory symptoms but no airflow limitation, often have activity limitation, exacerbations and evidence of airway disease.","authors":"Charlotte Suppli Ulrik","doi":"10.1136/ebmed-2016-110501","DOIUrl":"https://doi.org/10.1136/ebmed-2016-110501","url":null,"abstract":"Commentary on : Woodruff PG, Barr RG, Bleecker E, et al. Clinical significance of symptoms in smokers with preserved pulmonary function. N Engl J Med 2016;374:1811–21.[OpenUrl][1][CrossRef][2][PubMed][3]\u0000\u0000COPD is, according to the Global Initiative for Chronic Obstructive Lung Disease, defined as persistent airflow limitation, that is, the key diagnostic criterion is a postbronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio <0.70.1 However, this definition has clear limitations in clinical practice, as it does not take symptoms into account and only applies to individuals in whom fixed airflow limitation has developed.2 Furthermore, this diagnostic criterion, that is, FEV1/FVC ratio <0.70, is likely to be insensitive for recognition of early COPD.3 ,4 Some current or …\u0000\u0000 [1]: {openurl}?query=rft.jtitle%253DN%2BEngl%2BJ%2BMed%26rft.volume%253D374%26rft.spage%253D1811%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMoa1505971%26rft_id%253Dinfo%253Apmid%252F27168432%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx\u0000 [2]: /lookup/external-ref?access_num=10.1056/NEJMoa1505971&link_type=DOI\u0000 [3]: /lookup/external-ref?access_num=27168432&link_type=MED&atom=%2Febmed%2Fearly%2F2016%2F08%2F23%2Febmed-2016-110501.atom","PeriodicalId":12182,"journal":{"name":"Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/ebmed-2016-110501","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34689436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-10-01Epub Date: 2016-08-08DOI: 10.1136/ebmed-2016-110484
Corrado Tamburino, Piera Capranzano
Commentary on: Leon MB, Smith CR, Mack MJ, et al., PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016;374:1609–20[OpenUrl][1][CrossRef][2][PubMed][3]. Evidence derived from randomised clinical trials support transcatheter aortic valve replacement (TAVR) as a choice for patients with aortic stenosis with a prohibitive surgical risk and as a valid alternative therapy for those at high-risk of surgical mortality. Owing to increases in operator experience as well as improvements with transcatheter techniques and devices associated with reduction in procedural complications, TAVR has been progressively extended to less risky patients,1 despite the lack of rigorous clinical-trial assessment of this expansion. In the Placement of Aortic Transcatheter Valves 2 (PARTNER-2) Cohort A randomised trial, safety and effectiveness of TAVR with a lower-profile second-generation valve system were compared with conventional surgical aortic valve replacement (SAVR) in patients with intermediate-risk clinical … [1]: {openurl}?query=rft.jtitle%253DN%2BEngl%2BJ%2BMed%26rft.volume%253D374%26rft.spage%253D1609%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMoa1514616%26rft_id%253Dinfo%253Apmid%252F27040324%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1056/NEJMoa1514616&link_type=DOI [3]: /lookup/external-ref?access_num=27040324&link_type=MED&atom=%2Febmed%2F21%2F5%2F173.atom
{"title":"Transfemoral transcatheter aortic-valve replacement should be preferred over surgery in most intermediate-risk patients.","authors":"Corrado Tamburino, Piera Capranzano","doi":"10.1136/ebmed-2016-110484","DOIUrl":"https://doi.org/10.1136/ebmed-2016-110484","url":null,"abstract":"Commentary on: Leon MB, Smith CR, Mack MJ, et al., PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016;374:1609–20[OpenUrl][1][CrossRef][2][PubMed][3].\u0000\u0000Evidence derived from randomised clinical trials support transcatheter aortic valve replacement (TAVR) as a choice for patients with aortic stenosis with a prohibitive surgical risk and as a valid alternative therapy for those at high-risk of surgical mortality. Owing to increases in operator experience as well as improvements with transcatheter techniques and devices associated with reduction in procedural complications, TAVR has been progressively extended to less risky patients,1 despite the lack of rigorous clinical-trial assessment of this expansion. In the Placement of Aortic Transcatheter Valves 2 (PARTNER-2) Cohort A randomised trial, safety and effectiveness of TAVR with a lower-profile second-generation valve system were compared with conventional surgical aortic valve replacement (SAVR) in patients with intermediate-risk clinical …\u0000\u0000 [1]: {openurl}?query=rft.jtitle%253DN%2BEngl%2BJ%2BMed%26rft.volume%253D374%26rft.spage%253D1609%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMoa1514616%26rft_id%253Dinfo%253Apmid%252F27040324%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx\u0000 [2]: /lookup/external-ref?access_num=10.1056/NEJMoa1514616&link_type=DOI\u0000 [3]: /lookup/external-ref?access_num=27040324&link_type=MED&atom=%2Febmed%2F21%2F5%2F173.atom","PeriodicalId":12182,"journal":{"name":"Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/ebmed-2016-110484","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34739529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-10-01Epub Date: 2016-08-26DOI: 10.1136/ebmed-2016-110471
Rhonda Bell, Paula Robson
Commentary on: Jebeile H, Mijatovic J, Louie JC, et al. A systematic review and meta-analysis of energy intake and weight gain in pregnancy. Am J Obstet Gynecol 2016;214(4):465–83[OpenUrl][1][CrossRef][2][PubMed][3]. Recent updates to gestational weight gain (GWG) guidelines recommend women gain weight within a specific range, based on pre-pregnancy body mass index (BMI), to support the best pregnancy outcomes. While many women exceed the GWG guidelines, the extent to which this reflects inappropriate increases in energy intake is unclear. This study set out to determine whether a greater increment in reported energy intake between early and late pregnancy was associated with greater or excessive GWG. The authors conducted a systematic review of studies of women with a full-term singleton pregnancy that included measurement of … [1]: {openurl}?query=rft.jtitle%253DAm%2BJ%2BObstet%2BGynecol%26rft.volume%253D214%26rft.spage%253D465%26rft_id%253Dinfo%253Adoi%252F10.1016%252Fj.ajog.2015.12.049%26rft_id%253Dinfo%253Apmid%252F26739796%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1016/j.ajog.2015.12.049&link_type=DOI [3]: /lookup/external-ref?access_num=26739796&link_type=MED&atom=%2Febmed%2F21%2F5%2F192.atom
{"title":"Lack of a significant relationship between energy intake in pregnancy and gestational weight gain underlines the need for further evaluations of energy metabolism during this time.","authors":"Rhonda Bell, Paula Robson","doi":"10.1136/ebmed-2016-110471","DOIUrl":"https://doi.org/10.1136/ebmed-2016-110471","url":null,"abstract":"Commentary on: Jebeile H, Mijatovic J, Louie JC, et al. A systematic review and meta-analysis of energy intake and weight gain in pregnancy. Am J Obstet Gynecol 2016;214(4):465–83[OpenUrl][1][CrossRef][2][PubMed][3].\u0000\u0000Recent updates to gestational weight gain (GWG) guidelines recommend women gain weight within a specific range, based on pre-pregnancy body mass index (BMI), to support the best pregnancy outcomes. While many women exceed the GWG guidelines, the extent to which this reflects inappropriate increases in energy intake is unclear. This study set out to determine whether a greater increment in reported energy intake between early and late pregnancy was associated with greater or excessive GWG.\u0000\u0000The authors conducted a systematic review of studies of women with a full-term singleton pregnancy that included measurement of …\u0000\u0000 [1]: {openurl}?query=rft.jtitle%253DAm%2BJ%2BObstet%2BGynecol%26rft.volume%253D214%26rft.spage%253D465%26rft_id%253Dinfo%253Adoi%252F10.1016%252Fj.ajog.2015.12.049%26rft_id%253Dinfo%253Apmid%252F26739796%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx\u0000 [2]: /lookup/external-ref?access_num=10.1016/j.ajog.2015.12.049&link_type=DOI\u0000 [3]: /lookup/external-ref?access_num=26739796&link_type=MED&atom=%2Febmed%2F21%2F5%2F192.atom","PeriodicalId":12182,"journal":{"name":"Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/ebmed-2016-110471","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34340533","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-10-01Epub Date: 2016-08-09DOI: 10.1136/ebmed-2016-110459
Juan Luis Alcázar
Commentary on : Timmerman D, Van Calster B, Testa A, et al. Predicting the risk of malignancy in adnexal masses based on the simple rules from the international ovarian tumor analysis group. Am J Obstet Gynecol 2016;214:424–37. Adnexal masses are a common clinical problem, with ovarian cancer remaining as the most lethal gynaecological malignancy. Evidence shows that women with ovarian cancer should be primarily treated at specialised centres,1 while women with benign adnexal masses can be treated by general gynaecologists.2 Accurate diagnosis is essential for adequate triage. Currently, the best method for discriminating benign from malignant adnexal masses is ultrasound assessment by an expert examiner.3 The international ovarian tumour analysis (IOTA) group has proposed a simple risk estimation approach based on ultrasound features of the ovarian tumours (five benign and five malignant), the so-called …
{"title":"Ultrasound-based IOTA simple rules allow accurate malignancy risk estimation for adnexal masses.","authors":"Juan Luis Alcázar","doi":"10.1136/ebmed-2016-110459","DOIUrl":"https://doi.org/10.1136/ebmed-2016-110459","url":null,"abstract":"Commentary on : Timmerman D, Van Calster B, Testa A, et al. Predicting the risk of malignancy in adnexal masses based on the simple rules from the international ovarian tumor analysis group. Am J Obstet Gynecol 2016;214:424–37.\u0000\u0000Adnexal masses are a common clinical problem, with ovarian cancer remaining as the most lethal gynaecological malignancy. Evidence shows that women with ovarian cancer should be primarily treated at specialised centres,1 while women with benign adnexal masses can be treated by general gynaecologists.2 Accurate diagnosis is essential for adequate triage. Currently, the best method for discriminating benign from malignant adnexal masses is ultrasound assessment by an expert examiner.3 The international ovarian tumour analysis (IOTA) group has proposed a simple risk estimation approach based on ultrasound features of the ovarian tumours (five benign and five malignant), the so-called …","PeriodicalId":12182,"journal":{"name":"Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/ebmed-2016-110459","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34355086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-10-01Epub Date: 2016-08-12DOI: 10.1136/ebmed-2016-110406
Gwendolyn Vuurberg, Gino M M J Kerkhoffs
Commentary on: Derry S, Moore RA, Gaskell H, et al. Topical NSAIDs for acute musculoskeletal pain in adults. Cochrane Database Syst Rev 2015;(6):CD007402. Use of topical non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief is widely controversial in analgesic practice.1 For the topical NSAIDs to have an effect on acute pain, the formulation has to penetrate the skin. The expected advantages of this type of administration are both potential minimisation of systemic side effects and increase of local effect. However, there is still debate on these potential advantages as there is continuous lack of significant positive results.2–4 A Cochrane review update was recently carried out to assess the effect of topical NSAIDs used for acute musculoskeletal pain in adults.5 This review aimed to strengthen conclusions on the efficacy and safety of topically applied NSAIDs in acute musculoskeletal pain in adults, adding recently published studies to the previous search. The review included only double-blinded …
{"title":"Topical NSAIDs significantly reduces pain in adults with acute musculoskeletal injuries.","authors":"Gwendolyn Vuurberg, Gino M M J Kerkhoffs","doi":"10.1136/ebmed-2016-110406","DOIUrl":"https://doi.org/10.1136/ebmed-2016-110406","url":null,"abstract":"Commentary on: Derry S, Moore RA, Gaskell H, et al. Topical NSAIDs for acute musculoskeletal pain in adults. Cochrane Database Syst Rev 2015;(6):CD007402.\u0000\u0000Use of topical non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief is widely controversial in analgesic practice.1 For the topical NSAIDs to have an effect on acute pain, the formulation has to penetrate the skin. The expected advantages of this type of administration are both potential minimisation of systemic side effects and increase of local effect. However, there is still debate on these potential advantages as there is continuous lack of significant positive results.2–4 A Cochrane review update was recently carried out to assess the effect of topical NSAIDs used for acute musculoskeletal pain in adults.5 This review aimed to strengthen conclusions on the efficacy and safety of topically applied NSAIDs in acute musculoskeletal pain in adults, adding recently published studies to the previous search.\u0000\u0000The review included only double-blinded …","PeriodicalId":12182,"journal":{"name":"Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/ebmed-2016-110406","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34365611","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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