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Evidence-Based Medicine current issue



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'Spin in reports of clinical research

2016-11-23T22:46:06-08:00

Clinical research is frequently hampered by flaws in its design or conduct. Such biases have been well documented. However, reports of clinical research may also be biased and present results in a more favourable way than they deserve or downplay harms. Such ‘spin’ in reporting has been demonstrated empirically. This short commentary summarises some of the problems with spin in reports of clinical research as well as signposts to some of the empirical evidence demonstrating its effect.




Avoiding alert fatigue in pulmonary embolism decision support: a new method to examine 'trigger rates

2016-11-23T22:46:06-08:00

A clinical decision support system (CDSS) is integrated into the electronic health record (EHR) and allows physicians to easily use a clinical decision support (CDS) tool. However, often CDSSs are integrated into the EHR with poor adoption rates. One reason for this is secondary to ‘trigger fatigue’. Therefore, we developed a new and innovative usability process named ‘sensitivity and specificity trigger analysis’ (SSTA) as part of our larger project around a pulmonary embolism decision support tool. SSTA will enable programmers to examine optimal trigger rates prior to the integration of a CDS tool into the EHR, by using a formal method of analysis. We performed a retrospective chart review. The outcome of interest was physician ordering of a CT angiography (CTA). Phrases that signify common symptoms associated with pulmonary embolism were assessed as possible triggers for the CDSS tool. We then analysed each trigger's ability to predict physician ordering of a CTA. We found that the most sensitive way to trigger the Pulmonary Embolism CDS tool while still maintaining a high specificity was by combining 1 or more pertinent symptoms with 1 or more elements of the Wells criteria. This study explored a unique methodology, SSTA, used to limit inaccurate triggering of a CDS tool prior to integration into the EHR. This methodology can be applied to other studies aiming to decrease triggering rates and increase adoption rates of previously validated CDSS tools.




Value and usability of unpublished data sources for systematic reviews and network meta-analyses

2016-11-23T22:46:06-08:00

Peer-reviewed publications and conference proceedings are the mainstay of data sources for systematic reviews and network meta-analyses (NMA), but access to informative unpublished data is now becoming commonplace. To explore the usefulness of three types of ‘grey’ literature-clinical trials registries, clinical study reports and data from regulatory authorities-we conducted four case studies. The reporting of outcome data in peer-reviewed publications, the clinical trials registries and the clinical study reports for two clinical trials—one in melanoma, one in juvenile idiopathic arthritis (JIA)—was examined. In addition, we assessed the value of including unpublished data from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in evidence syntheses of hepatitis C virus (HCV) and chronic obstructive pulmonary disease (COPD), respectively. For the clinical trials in melanoma and JIA, we identified outcome parameters on ClinicalTrials.gov additional to those reported in the peer-reviewed publications: subgroup data and additional efficacy end points/extended follow-up, respectively. The clinical study report also provided results for several subgroups unavailable elsewhere. For HCV and COPD, additional outcome data were obtained from the EMA European Public Assessment Report (EPAR) and the FDA, respectively, including data on subgroups and mortality. We conclude that data from these grey literature sources have the potential to influence results of systematic reviews and NMAs, and may thus have implications for healthcare decisions. However, it is important to consider carefully the availability, reliability and consequent usability of these data sources in systematic reviews and NMAs.




Non-pharmacological treatment of depression: a systematic review and evidence map

2016-11-23T22:46:06-08:00

Background

The comparative effectiveness of non-pharmacological treatments of depression remains unclear.

Methods

We conducted an overview of systematic reviews to identify randomised controlled trials (RCTs) that compared the efficacy and adverse effects of non-pharmacological treatments of depression. We searched multiple electronic databases through February 2016 without language restrictions. Pairs of reviewers determined eligibility, extracted data and assessed risk of bias. Meta-analyses were conducted when appropriate.

Result

We included 367 RCTs enrolling ~20 000 patients treated with 11 treatments leading to 17 unique head-to-head comparisons. Cognitive behavioural therapy, naturopathic therapy, biological interventions and physical activity interventions reduced depression severity as measured using standardised scales. However, the relative efficacy among these non-pharmacological interventions was lacking. The effect of these interventions on clinical response and remission was unclear. Adverse events were lower than antidepressants.

Limitation

The quality of evidence was low to moderate due to inconsistency and unclear or high risk of bias, limiting our confidence in findings.

Conclusions

Non-pharmacological therapies of depression reduce depression symptoms and should be considered along with antidepressant therapy for the treatment of mild-to-severe depression. A shared decision-making approach is needed to choose between non-pharmacological therapies based on values, preferences, clinical and social context.




LABA/LAMA combinations instead of LABA/ICS combinations may prevent or delay exacerbations of COPD in some patients

2016-11-23T22:46:06-08:00

Commentary on: Wedzicha JA, Banerji D, Chapman KR, et al.. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med 2016;374:2222–34 .

Context

A substantial body of evidence shows that inhaled corticosteroids (ICSs) reduce the risk of exacerbations by 10–20% beyond that achieved by inhaled long-acting β2-adrenergic agonist (LABA) and also reduce progression of lung function loss, improving health-related quality of life.1 However, drawbacks of ICSs in chronic obstructive pulmonary disease (COPD) (increased risk of pneumonia, osteoporosis, hyperglycaemia in patients with diabetes, cataracts, skin bruising and glaucoma) are the reason why all COPD guidelines recommend ICSs only for patients with severe impairment and high risk of exacerbations.1 Nonetheless, ICSs are still overprescribed worldwide.2

Methods

A randomised, double-blind, double dummy, non-inferiority trial lasting 52 weeks enrolled 3362 patients suffering from COPD with a post-bronchodilator forced expiratory volume in 1 second of at least...




Most add-on therapies to metformin have similar effects on HbA1c

2016-11-23T22:46:06-08:00

Commentary on: Maruthur NM, Tseng E, Hutfless S, et al.. Diabetes medications as monotherapy or metformin-based combination therapy for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med 2016;164(11):740–51 .

Context

Current guidelines for type 2 diabetes recommend metformin as first-line therapy, but offer no conclusive guidance for choosing among at least six drug classes as add-on to metformin in patients in whom glycaemic targets are not met.1 In light of accumulating evidence for novel agents, it is imperative to update the comparative effectiveness and safety of available antidiabetic medications. Maruthur and colleagues have addressed this question through a recently published systematic review and meta-analysis, which assesses the effect of all commonly used glucose-lowering drug classes on long-term and intermediate outcomes.

Methods

This was a systematic review and meta-analysis of randomised controlled trials (RCTs) and observational studies that included head-to-head comparisons of...




Existing evidence is insufficient to justify metformin or other agents as first-line therapy for type 2 diabetes

2016-11-23T22:46:06-08:00

Commentary on: Palmer SC, Mavridis D, Nicolucci A, et al.. Comparison of clinical outcomes and adverse events associated with glucose-lowering drugs in patients with type 2 diabetes: a meta-analysis. JAMA 2016;316:313–324 .

Context

A broad consensus supports the use of metformin as first-line therapy for patients with type 2 diabetes. Clinicians and patients, however, may be interested in using newer antihyperglycaemic drugs as first-line treatment, but their relative advantages to metformin—beyond burden of treatment and hypoglycaemic potential—remain uncertain. The systematic review by Palmer et al sought to evaluate the relative efficacy and safety of glucose-lowering drugs in patients with type 2 diabetes.

Methods

A systematic review was conducted of randomised trials testing any drug class for >24 weeks, used alone or in combination to achieve glycaemic control in adults with type 2 diabetes. The primary outcome was cardiovascular mortality. Secondary end points were patient-important outcomes (eg, all-cause...




Aspirin reduces cardiovascular events in primary prevention of cardiovascular disease but at a near equivalent risk of increased bleeding

2016-11-23T22:46:06-08:00

Commentary on: Guirguis-Blake JM, Evans CV, Senger CA, et al.. Aspirin for the primary prevention of cardiovascular events: a systematic evidence review for the US Preventive Services Task Force. Ann Intern Med 2016;164:804–13 .

Context

The use of aspirin in primary prevention of cardiovascular disease (CVD) remains controversial, as randomised controlled trials (RCTs) have produced mixed results. Recently, the United States Preventive Services Task Force (USPSTF) published updated recommendations on the use of aspirin for primary prevention of CVD and colorectal cancer.1 This systematic review and meta-analysis served as the basis for these USPSTF recommendations for primary CVD prevention.

Methods

All trials from the previous 2009 USPSTF guideline on the use of aspirin for primary CVD prevention (minimum of 75 mg every other day for 1 year or more) in adults aged 40 or more were included, and a comprehensive literature search for additional trials from...




Uncertainty in evidence synthesis limits clinical applicability of a clinical and cost-effectiveness analysis of induction of labour methods

2016-11-23T22:46:06-08:00

Commentary on: Alfirevic Z, Keeney E, Dowswell T, et al.. Methods to induce labour: a systematic review, network meta-analysis and cost-effectiveness analysis. BJOG 2016;123:1462–70 .

Context

The goal of induction of labour (IOL) is to achieve vaginal delivery by stimulation of uterine contractions before the spontaneous onset of labour. Variations in the management of IOL likely affect rates of caesarean delivery (CD), particularly the use of cervical ripening agents for the unfavourable cervix. This systematic review and meta-analysis looks at the various methods of labour induction and compares them from a clinical and cost-effectiveness perspective.

Methods

This was a review of randomised controlled trials (RCTs) examining pharmacological, mechanical and complementary (ie, acupuncture) interventions to induce labour. Outcomes included were vaginal delivery not achieved within 24 hours (VD24); uterine hyperstimulation with fetal heart rate (FHR) changes; CD; serious maternal and neonatal morbidity or mortality; instrumental delivery; maternal satisfaction...




Compared to conventional CPR for in-hospital cardiac arrest, extracorporeal-CPR is associated with improved survival to hospital discharge and more favourable neurological outcome

2016-11-23T22:46:06-08:00

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 .

Context

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).

Methods

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...




In individuals at intermediate risk for cardiovascular disease, treatment with rosuvastatin but not candesartan plus hydrochlorothiazide lowers cardiovascular disease event rates

2016-11-23T22:46:06-08:00

Commentary on: Lonn EM, Bosch J, López-Jaramillo P, et al.. Blood-pressure lowering in intermediate-risk persons without cardiovascular disease. N Engl J Med 2016;374:2009–20 . Yusuf S, Bosch J, Dagenais G, et al. Cholesterol lowering in intermediate-risk persons without cardiovascular disease. N Engl J Med 2016;374:2021–31.

Context

Cardiovascular diseases (CVD) are the number one cause of death globally: more people die annually from CVDs than from any other cause.1 The incidence of CVD rises progressively with increasing blood pressure (BP) and with increasing levels of total and low density lipoprotein (LDL) cholesterol. Pharmacological treatment of BP with several classes of drugs and of lipids with HMG-CoA reductase inhibitors (statins) have been demonstrated to reduce the incidence of CVD.2 3 Antihypertensive trials have predominantly enrolled individuals at specific BP levels and titrated medications to achieve either a specific target BP or a specific decrease...




Rate of epilepsy in people with autism and the rate of autism in people with epilepsy are high

2016-11-23T22:46:06-08:00

Commentary on: Sundelin HE, Larsson H, Lichtenstein P, et al.. Autism and epilepsy: a population-based nationwide cohort study. Neurology 2016;87:192–7.

Context

Population-based studies can provide information on the risk of people with autism developing epilepsy. Examination of family members of individuals with epilepsy can also provide a likelihood of a genetic link between autism and epilepsy. Sundelin et al carried out a register-based population study aimed at providing HRs for those with autism (ASD, autism spectrum disorder) developing epilepsy, those with epilepsy having ASD and relatives of people with epilepsy developing ASD.

Methods

Cases were identified using the ICD-9 or ICD-10 codes from the Swedish National Patient Register, which includes nationwide inpatient diagnoses from 1987 and, since 2001, hospital-based outpatient care. Siblings, offspring and parents of all participants with epilepsy were identified, with up to five controls matched for age, sex and county of residence...




Implementing evidence-based practices improves neonatal outcomes

2016-11-23T22:46:06-08:00

Commentary on: Zeitlin J, Manktelow BN, Piedvache A, et al.. Use of evidence based practices to improve survival without severe morbidity for very preterm infants: results from the EPICE population based cohort. BMJ 2016;354:i2976 .

Context

Translating scientific evidence into evidence-based practice in the ‘real world’ has been challenging for many reasons, ranging from the lack of generalisability of results from highly controlled clinical trial situations to barriers arising from organisational, cultural and personal factors.1 Yet, it is critical that we overcome these barriers if we are to really improve patient outcomes. In particular, evidence for efficacy of implementation of evidence-based practices on a large scale has been lacking. In this study, the authors prospectively examined a large cohort of infants (n=7336) born preterm (between 24+0 and 31+6 weeks gestational age) in 335 maternity units and admitted to 242 neonatal units across 19 regions in 11 European...




Low-dose second-generation oral contraceptives are associated with the lowest increased risk of cardiovascular adverse effects

2016-11-23T22:46:06-08:00

Commentary on: Weill A, Dalichampt M, Raguideau F, et al.. Low dose oestrogen combined oral contraception and risk of pulmonary embolism, stroke, and myocardial infarction in five million French women: cohort study. BMJ 2016;353:i2002 .

Context

Oral contraceptives (OCs) are associated with an increased risk of cardiovascular disease. The association varies depending on whether the cardiovascular disease is arterial or venous and with varying progestogens and dosages of the oestrogen compound ethinyloestradiol. A recent Cochrane review concluded that OCs with the progestogens gestodene, desogestrel, cyproterone acetate or drospirenone are associated with 50–80% higher risk of venous thromboembolism compared to OCs with the progestogen compound levonorgestrel.1 Another study concluded that only OCs with ethinyloestradiol dosages of 50 µg or above are associated with increased risk of myocardial infarction and ischaemic stroke.2

This observational cohort study analysed the risk of pulmonary embolism, ischaemic stroke and myocardial infarction...




Careful monitoring of fetal growth and maternal nutritional status should be practiced in pregnant women with a history of bariatric surgery

2016-11-23T22:46:06-08:00

Commentary on: Chevrot A, Kayem G, Coupaye M, et al.. Impact of bariatric surgery on fetal growth restriction: experience of a perinatal and bariatric surgery center. Am J Obstet Gynecol 2016;214:655.e1–7 .

Context

The proportion of pregnancies after bariatric surgery has been increasing in the last few decades and in some countries they now constitute around 1% of annual deliveries.1 2 Maternal obesity is associated with several adverse pregnancy outcomes such as gestational diabetes, preterm birth, stillbirth and macrosomia. Theoretically, weight loss prior to pregnancy would reduce such risks. This appears to be the case in women with weight loss induced by bariatric surgery for the outcomes gestational diabetes and macrosomia,3 but not for the outcome preterm birth where risks instead are increased.4 There is concern that bariatric surgery may cause fetal growth restriction2 3




Morphine exposure in preterm infants correlates with impaired cerebellar growth and poorer neurodevelopmental outcome

2016-11-23T22:46:06-08:00

Commentary on: Zwicker JG, Miller SP, Grunau RE, et al.. Smaller cerebellar growth and poorer neurodevelopmental outcomes in very preterm infants exposed to neonatal morphine. J Pediatr 2016;172:81–7 .

Context

Optimal care of preterm infants includes adequate treatment of pain and agitation. However, guidelines caution against the routine use of opioids in common situations such as mechanical ventilation, given the potential for respiratory adverse effects.1 Despite this caution, opioid exposure for this indication remains common.2 Conflicting data exist regarding the impact of this exposure on the developing brain.3 This prospective cohort study examines the relationship between morphine exposure in infants born very preterm and brain growth at term-equivalent age as well as neurodevelopmental outcomes at 18 months corrected age.

Methods

This study included 136 infants born at 24–32 weeks gestational age who underwent magnetic resonance imaging of the brain near birth and...




Cognitive adverse effects and brain deterioration associated with use of anticholinergic activity medicines in older adults

2016-11-23T22:46:06-08:00

Commentary on: Risacher SL, McDonald BC, Tallman EF, et al.. Association between anticholinergic medication use and cognition, brain metabolism, and brain atrophy in cognitively normal older adults. JAMA Neurol 2016;73:721–32 .

Context

Older people are particularly vulnerable to adverse cognitive effects and risk of dementia following exposure to medicines with anticholinergic activity;1 however, the biological basis for these effects remains unclear.2 The risk of anticholinergic adverse effects increases with age, polypharmacy, comorbidities, pre-existing cognitive impairment, cholinergic neuronal degeneration and changes in pharmacokinetic and pharmacodynamic properties. This study examined whether medicines with anticholinergic activity alter brain glucose metabolism, and the impact this has on brain structure, function and cognitive decline.

Methods

This retrospective cohort study involved 402 participants from the Alzheimer's Disease Neuroimaging Initiative (ADNI) centre and 49 participants from the Indiana Memory and Aging Study (IMAS). Data on cognitive and neuroimaging findings...




Traditionally taught clinical variables and risk factors perform poorly in the prediction of acute coronary syndromes in the emergency department

2016-11-23T22:46:06-08:00

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 .

Context

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.

Methods

Studies included in this systematic review had to (1) involve patients presenting to an ED with suspected...




Determination of a single, universal threshold for caesarean section rate is not the way forward

2016-11-23T22:46:06-08:00

Commentary on: Molina G, Weiser TG, Lipsitz SR, et al.. Relationship between cesarean delivery rate and maternal and neonatal mortality. JAMA 2015;314:2263–70.

Context

Over the past decades, the steady rise in caesarean section rates worldwide has led to increased research, debate and concern among clinicians, scientists, policymakers and governments, with sustained questions: What is the appropriate caesarean section rate? What is the rate or range that achieves best maternal and perinatal outcomes? Several ecological studies have been conducted to answer these questions at population level.1 In April 2015, WHO released a Statement on Caesarean Section Rates2 3 summarising the evidence on population-level caesarean section rates versus maternal/perinatal outcomes, replacing the earlier 1985 WHO Statement, which had suggested that rates higher than 10–15% were not justifiable.4

Methods

This study was a cross-sectional analysis of nationally representative data evaluating...




Evidence pyramids

2016-11-23T22:46:06-08:00

I read with great interest the Perspective pieces and accompanying editorial on evidence pyramids in your August 2016 journal.1–3 In my prior work as a medical policy researcher for two health insurance plans, it was disheartening to find that industries and clinicians alike not uncommonly relied on synthesised summaries and guidelines as a sole source of information, and systematic reviews and meta-analysis as a source of ‘truth’.

With this in mind, I found the ‘New Evidence Pyramid’ proposed by Murad et al3 to be ingenious. It is graphically simple while conveying that quality varies in primary studies, and that there are inherent difficulties in fully relying on systematic reviews and meta-analysis without understanding the strength of the primary evidence and the methodology of the analyses. Murad et al notably omit synthesised summaries for clinical reference and society guidelines from their model,...




Letter in reply to 'Evidence pyramids from Dr Kaufmann

2016-11-23T22:46:06-08:00

Dr Kaufmann1 suggests that readers should use the ‘New Evidence Pyramid’ which conveys a hierarchy of quality across primary studies2 rather than the ‘EBHC Pyramid 5.0’ which conveys a hierarchy of comprehensiveness across types of information resources (primary studies, systematic reviews, guidelines and synthesised summaries for clinical reference).3 However, these pyramids are complementary and address very different issues. The hierarchy of validity of primary studies (and the recognition that quality varies so the hierarchy should not be interpreted strictly) reported by Murad et al in the ‘New Evidence Pyramid’ should be used by those creating systematic reviews, guidelines and synthesised summaries for clinical reference. If not, these summary resources will suffer in validity and pass forward errors in omission and errors in translation.

However, busy clinicians do not have the time to access and assess the primary studies for most of their information...




Letter in reply to 'Evidence pyramids' from Dr Kaufmann

2016-11-23T22:46:06-08:00

Dr Kaufmann makes an important point that quality varies in primary studies and that one should be sceptical when reading the medical literature. Systematic review of poor quality evidence does not make that evidence more valid. Dr Kaufmann suggests that by reviewing the primary literature for themselves, readers would detect potential biases, conflicts of interest and better understand the implications of the findings. I am not so sure. I am concerned that the busy clinician with minimal EBM training would not detect design flaws (nor understand their impact on the results) nor review author affiliations to recognise potential conflicts of interest; especially considering many only read the abstract of research articles and often only the conclusion section of the abstract. I also am concerned that busy clinicians will only find or review a limited sampling of the available literature on a topic. How will the clinician deal with...




Where should preappraised evidence summaries and guidelines place in a pyramid?

2016-11-23T22:46:06-08:00

The letter by Kaufmann1 is quite reassuring as it demonstrates that policy researchers have intuitively and astutely questioned simple evidence hierarchies and were sceptical about using study design or study label as a surrogate for validity. This was the impetus for proposing our revised pyramid.

The letter also reminds us that there are higher order scientific publications (guidelines and clinical synopses) that can also have variable levels of credibility. How can we place such highly synthesised and preappraised summaries in a pyramid? The pyramid suggested by Alper and Haynes2 includes such summaries but that pyramid conveys a hierarchy of ‘usefulness’ rather than of validity or credibility. In fact, many guidelines are poorly developed and not credible.3

We believe that these summaries can be appraised in a two-step approach (similar to a systematic review)4 and should not be placed in a pyramid....