Evidence-based Medicine[JOURNAL]

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In children 7 years of age, prenatal antidepressant exposure is not associated with increased risk of poor behavioural outcomes after adjusting for maternal factors including antenatal mood.

Gentile S, Fusco ML

Evid Based Med · 2017 Jun · PMID 28348049 · Publisher ↗

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Caesarean section is associated with offspring obesity in childhood and young adulthood.

Kuhle S, Woolcott CG

Evid Based Med · 2017 Jun · PMID 28341620 · Publisher ↗

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Rating the certainty in evidence in the absence of a single estimate of effect.

Murad MH, Mustafa RA, Schünemann HJ … +2 more , Sultan S, Santesso N

Evid Based Med · 2017 Jun · PMID 28320705 · Full text

When studies measure or report outcomes differently, it may not be feasible to pool data across studies to generate a single effect estimate (ie, perform meta-analysis). Instead, only a narrative summary of the effect ac... When studies measure or report outcomes differently, it may not be feasible to pool data across studies to generate a single effect estimate (ie, perform meta-analysis). Instead, only a narrative summary of the effect across different studies might be available. Regardless of whether a single pooled effect estimate is generated or whether data are summarised narratively, decision makers need to know the certainty in the evidence in order to make informed decisions. In this guide, we illustrate how to apply the constructs of the GRADE (Grading of Recommendation, Assessment, Development and Evaluation) approach to assess the certainty in evidence when a meta-analysis has not been performed and data were summarised narratively.

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Reflections on using non-inferiority randomised placebo controlled trials in assessing cardiovascular safety of new agents for treatment of type 2 diabetes.

Campbell-Scherer D

Evid Based Med · 2017 Apr · PMID 28274954 · Publisher ↗

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 unac... 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.

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Semaglutide is non-inferior to placebo for cardiovascular outcomes in patients with type 2 diabetes.

Campbell-Scherer D

Evid Based Med · 2017 Apr · PMID 28270434 · Publisher ↗

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Similar prostate cancer and all-cause mortality in men with localised prostate cancer undergoing surgery or radiation therapy versus active monitoring at 10 years of follow-up.

Dahm P, Ilic D, Wilt T

Evid Based Med · 2017 Jun · PMID 28258067 · Publisher ↗

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Adverse events associated with mood stabiliser treatment should be continuously monitored in patients diagnosed with bipolar affective disorder.

Nielsen RE, Licht RW

Evid Based Med · 2017 Apr · PMID 28254753 · Publisher ↗

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Pregabalin is effective in reducing fibromyalgia pain.

Argoff C

Evid Based Med · 2017 Apr · PMID 28242609 · Publisher ↗

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Thalamotomy using MRI-guided focused ultrasound significantly improves contralateral symptoms and quality of life in essential tremor.

Zrinzo L

Evid Based Med · 2017 Apr · PMID 28242608 · Publisher ↗

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Both a stage shift and changes in stage-specific survival have contributed to reductions in breast cancer mortality.

Duffy SW, Etzioni R, Sasieni P

Evid Based Med · 2017 Apr · PMID 28228386 · Publisher ↗

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Team-based primary care with integrated mental health is associated with higher quality of care, lower usage and lower payments received by the delivery system.

English AF

Evid Based Med · 2017 Jun · PMID 28213461 · Publisher ↗

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Patients with coronary heart disease and very low blood pressure are at increased risk of cardiovascular events.

Rahimi K, Mohseni H

Evid Based Med · 2017 Apr · PMID 28188226 · Publisher ↗

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Practising evidence-based medicine (EBM): a descriptive analysis of medical students' whole-task EBM assignments.

Maggio LA, Capdarest-Arest N

Evid Based Med · 2017 Apr · PMID 28167494 · Publisher ↗

Researchers have suggested whole-task learning activities to practice and teach evidence-based medicine (EBM); however, limited description exists of their use in EBM curricula. This article describes medical students' e... Researchers have suggested whole-task learning activities to practice and teach evidence-based medicine (EBM); however, limited description exists of their use in EBM curricula. This article describes medical students' execution of a whole-task EBM assignment and characterises themes emerging from assignment submissions. Between 2013 and 2015, Stanford University's paediatric clerkship students completed a whole-task EBM assignment based on a patient encounter. The assignment captured students' efforts to perform all EBM steps and describe their patient scenario and future knowledge needs strategies. Assignments were analysed using descriptive statistics and qualitative description. 123 students completed the assignment. Students formulated therapy (n=76), prognosis (n=18), diagnosis (n=15), harm (n=9) and aetiology (n=2) questions, and used a single (n=58) or multiple information resources (n=57). Based on evidence appraisal, 95 students indicated that the found evidence would inform future practice while 16 were sceptical of its conclusivity. 65 learners wanted to share evidence with colleagues; 33 with patients and families. To meet future knowledge needs, learners suggested using a structured approach (eg, PICO (patient, intervention, comparison and outcome); n=58), reading more primary literature (n=22) and creating question logs (n=21). This article provides a glimpse into students' EBM process and demonstrates the feasibility of whole-task activities for use in EBM training. Findings related to students' clinical uncertainty and information sharing raise questions about coverage of these topics in current EBM training and suggest that further investigation is warranted.

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SGLT2 inhibitor empagliflozin reduces renal outcomes and dampens the progressive reduction in glomerular filtration rate in patients with type 2 diabetes and antecedents of cardiovascular disease.

Scheen AJ

Evid Based Med · 2017 Apr · PMID 28159856 · Publisher ↗

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Passive leg raising may serve as the primary method to quickly assess fluid responsiveness in haemodynamically unstable patients.

Cherpanath TG

Evid Based Med · 2017 Apr · PMID 28159855 · Publisher ↗

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Survey of instructions for authors on how to report an update of a systematic review: guidance is needed.

Pieper D, Mathes T

Evid Based Med · 2017 Apr · PMID 28137732 · Publisher ↗

Systematic reviews have become the cornerstone of evidence-based healthcare. Approximately half of the systematic reviews are out of date after 5.5 years, and keeping them up to date remains a huge challenge. Despite new... Systematic reviews have become the cornerstone of evidence-based healthcare. Approximately half of the systematic reviews are out of date after 5.5 years, and keeping them up to date remains a huge challenge. Despite new guidance on when and how to update systematic reviews, there seems to be a lack of guidance on how to report updates of systematic reviews. Therefore, we decided to systematically analyse instruction for authors in biomedical journals regarding guidance on reporting updates of systematic reviews. We conducted a survey investigating 250 journals. The journal list was derived by a twofold strategy. First, we chose a list of journals that were included in a recently published survey of systematic reviews. This list was augmented by a PubMed search for published updates of systematic reviews. For each journal, we checked the instructions for authors for any content or links related to updating systematic reviews in September 2016. Out of 250 journals, we found only one with guidance clearly related to updates of systematic reviews, namely the BioMed Central journal, Nevertheless, concrete guidance on reporting is lacking as it is stated that authors are encouraged to be innovative in how to report and present systematic review updates. This makes clear that there remains a fundamental uncertainty of how authors willing to update a previously published systematic review should act as even the leading journal in evidence syntheses does not have clear guidance. Debate is necessary on how to report updates of systematic reviews.

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