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Evidence-Based Medicine current issue



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Wrong guidelines: why and how often they occur

2017-01-24T07:25:00-08:00

Evidence-based guidelines are considered an essential tool in assisting physicians, policymakers and patients when choosing among alternative care options and are considered unbiased standards of care. Unfortunately, depending on how their reliability is measured, up to 50% of guidelines can be considered untrustworthy. This carries serious consequences for patients' safety, resource use and health economics burden. Although conflict of interests, panel composition and methodological flaws are traditionally thought to be the main reasons undermining their untrustworthiness, corruption and waste of biomedical research also contribute. We discuss these issues in the hope for a wider awareness of the limits of guidelines.




Wrong guidelines: how to detect them and what to do in the case of flawed recommendations

2017-01-24T07:25:00-08:00

Any evidence-based recommendation needs careful assessment of its methodological background as well as of its content trustworthiness, especially given that following it will not necessarily produce the intended clinical outcomes. There are no established instruments to evaluate guidelines for their content, while useful tools assessing the quality of methods followed are well recognised and adopted. We suggest a ‘safety bundle’ considering methodological aspects and content trustworthiness of guidelines, by adopting the GRADE method in a backward fashion. Sharing the critical analysis of the guidelines with patients, including any eventual uncertainty about them, is of key importance in order to avoid the possible adverse effects derived from following the wrong guidelines. Such critical approach is also helpful and beneficial in producing better care pathways, health policy decisions and more relevant and ethical research.




Evidence-based medicine: a persisting desire under fire

2017-01-24T07:25:00-08:00

Healthcare infrastructure and medical schools in Syria have been greatly compromised by military conflict and humanitarian disaster. Medical students and healthcare professionals reached out for remote learning opportunities. Surprisingly, they desired a curriculum in evidence-based medicine. We report on a curriculum that was delivered to 126 learners using an online remote delivery platform. This experience demonstrates the feasibility of this approach in disaster-stricken areas and underscores the importance of evidence-based medicine even under such conditions.




Informing treatment decisions through meta-analysis: to network or not?

2017-01-24T07:25:00-08:00

Evidence from randomised trials and their meta-analyses is typically formed of head-to-head comparisons of a couple of treatments; multiarm trials are infrequent. However, in real-life healthcare, there are many more than two treatment options for a particular condition. To be relevant for the shop-floor of practice, evidence-based medicine requires the use a comprehensive approach to compile, compare and contrast evidence on all options in one synthesis. Network meta-analysis (NMA) offers exactly such a solution. It generates a rank order of the available treatments for practitioners and policymakers that has the merit of objectivity. However, reviewers should make transparent the limitations of NMA as it uses direct and indirect comparisons, inevitably collating data with a certain degree of heterogeneity. This approach is increasingly being deployed to underpin evidence syntheses for incorporating research into practice.




Cholesterol paradox: a correlate does not a surrogate make

2017-01-24T07:25:00-08:00

The global campaign to lower cholesterol by diet and drugs has failed to thwart the developing pandemic of coronary heart disease around the world. Some experts believe this failure is due to the explosive rise in obesity and diabetes, but it is equally plausible that the cholesterol hypothesis, which posits that lowering cholesterol prevents cardiovascular disease, is incorrect. The recently presented ACCELERATE trial dumbfounded many experts by failing to demonstrate any cardiovascular benefit of evacetrapib despite dramatically lowering low-density lipoprotein cholesterol and raising high-density lipoprotein cholesterol in high-risk patients with coronary disease. This clinical trial adds to a growing volume of knowledge that challenges the validity of the cholesterol hypothesis and the utility of cholesterol as a surrogate end point. Inadvertently, the cholesterol hypothesis may have even contributed to this pandemic. This perspective critically reviews this evidence and our reluctance to acknowledge contradictory information.




Grading the quality of evidence in complex interventions: a guide for evidence-based practitioners

2017-01-24T07:25:00-08:00

Evidence-based practitioners who want to apply evidence from complex interventions to the care of their patients are often challenged by the difficulty of grading the quality of this evidence. Using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach and an illustrative example, we propose a framework for evaluating the quality of evidence that depends on obtaining feedback from the evidence user (eg, guideline panel) to inform: (1) proper framing of the question, (2) judgements about directness and consistency of evidence and (3) the need for additional contextual and qualitative evidence. Using this framework, different evidence users and based on their needs would consider the same evidence as high, moderate, low or very low.




Scoping systematic review on the extent, nature and quality of evidence underlying ophthalmic and paraophthalmic education

2017-01-24T07:25:00-08:00

Background

Effective education of relevant professionals underpins provision of quality eye healthcare.

Objectives

This scoping systematic review had 2 aims: first to investigate the extent and nature of scholarly output published on ophthalmic and paraophthalmic education, and second to focus on the quality of reporting of randomised controlled trials (RCTs) identified.

Study selection

A search strategy was created and applied to PubMed. Any scholarly publications on any aspect of education of those involved in the care of patients with visual problems as the main theme or context was selected. Predefined data were extracted.

Findings

Of 255 studies included, the most common type of scholarly publications were descriptions of an educational innovation, opinion pieces and descriptive studies. RCTs made up 5.5% of the sample. Most of the 14 RCTs failed to report most of the items recommended in the CONSORT guidelines.

Conclusions

This review highlights the need for investigators, ethical committees and journals to insist on a better quality of RCT conduct than is presently apparent, but also that clinicians should not be blind to the strengths of non-RCT-based studies in the field of education.




Intraoperative on-table endoscopic retrograde cholangiopancreatography (ERCP) is better than laparoscopic bile duct exploration for concomitant bile duct stones during emergency laparoscopic cholecystectomy

2017-01-24T07:25:00-08:00

Commentary on: Poh BR, Ho SP, Sritharan M, et al.. Randomized clinical trial of intraoperative endoscopic retrograde cholangiopancreatography versus laparoscopic bile duct exploration in patients with choledocholithiasis. Br J Surg 2016;103:1117–24 .

Context

Some 15% of patients with gallbladder (GB) stones have concomitant stones in the bile duct (BD) believed to have migrated out from the GB. While asymptomatic GB stones may be managed expectantly, BD stones, if detected, require removal even if asymptomatic because of their potential to cause two major complications: acute cholangitis and acute pancreatitis. In patients with concomitant GB and BD stones, open surgery was standard approach but was associated with wound morbidity and T-tube-related problems. With the advent of endoscopic retrograde cholangiopancreatography (ERCP) in the 1970s, endoscopic removal of BD stones gradually received wide acceptance.1 With the introduction of laparoscopic cholecystectomy (LC) in the late 1980s, a two-stage minimally invasive procedure...




Liraglutide, a GLP-1 receptor agonist, prevents cardiovascular outcomes in patients with type 2 diabetes

2017-01-24T07:25:00-08:00

Commentary on: Marso SP, Daniels GH, Brown-Frandsen K, et al.. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2016;375:311–22 .

Context

Despite the treatments available for type 2 diabetes, about two-thirds of these patients die from associated heart disease or stroke.1 Approval of the first glucagon-like peptide-1 agonist (GLP-1), exenatide, by the FDA in 2005 generated an expectation that the clinical outcomes in type 2 diabetes would be improved. However, we still do not have definitive evidence that exenatide does this, although a clinical trial to determine this, the Exenatide Study of Cardiovascular Even Lowering (EXSCEL) trial, is under way.2 Subsequently, other GLP-1 receptor agonists, including liraglutide, have also been approved and used for 10 years without clinical outcome data.3 Recently, the results of Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcomes Results (LEADER) have been published.

...



Early initiation of antiretroviral therapy prevents HIV transmission to seronegative sexual partners

2017-01-24T07:25:01-08:00

Commentary on: Cohen MS, Chen YQ, McCauley M, et al.. Antiretroviral therapy for the prevention of HIV-1 transmission. N Engl J Med 2016;375:830–9 .

Context

In 2011, interim results from the HIV Prevention Trials Network (HPTN) 052 trial confirmed that early antiretroviral therapy (ART) markedly reduces HIV transmission in serodiscordant couples.1 This, along with evidence that therapeutic benefits accrue from starting ART earlier,1–3 led the WHO to recommend that all patients with HIV infection start ART as soon as possible after diagnosis.4 Cohen et al have now published a final analysis from their original HPTN 052 report.

Methods

The HPTN 052 trial randomised ART-naïve participants to initiate ART early, between 350 and 550 CD4 cells/µL, or to delay initiation until 250 cells/µL. Uninfected primary sexual partners were also enrolled. Results were released in May 2011 following...




Intensive treatment of hypertension to a SBP <120 mm Hg in patients aged 75 and over reduces mortality and cardiovascular events

2017-01-24T07:25:01-08:00

Commentary on: Williamson JD, Supiano MA, Applegate WB, et al.. Intensive vs standard blood pressure control and cardiovascular disease outcomes in adults aged ≥75 years. A randomized clinical trial. JAMA 2016;315:2673–82 .

Context

There is uncertainty regarding optimal blood pressure (BP) targets in treating hypertension. Most recent guidelines have recommended a systolic target of <140 mm Hg. The Systolic Blood Pressure Intervention Trial (SPRINT) compared cardiovascular (CV) outcomes in non-diabetic hypertensive patients randomised to standard (systolic blood pressure (SBP) <140 mm Hg) or intensive treatment (<120 mm Hg).1 Composite CV events and total mortality were significantly reduced with intensive treatment. A prespecified analysis evaluated older patients (≥75) and has now been published.

Methods

SPRINT compared outcomes with treatment targets of <120 mm Hg and <140 mm Hg in hypertensive patients at medium/high CV risk identified by previous CV events (except stroke), high Framingham risk scores or age ≥75.1 Patients with diabetes or recent...




In critically ill patients with acute kidney injury stage 2, early initiation of renal replacement therapy is associated with reduced 90-day mortality compared to delayed initiation

2017-01-24T07:25:01-08:00

Commentary on: Zarbock A, Kellum JA, Schmidt C, et al.. Effect of early vs delayed initiation of renal replacement therapy on mortality in critically ill patients with acute kidney injury: the ELAIN randomized clinical trial. JAMA 2016;315(20):2190–9 .

Context

Clinical practice of acute renal replacement therapy (RRT) is variable. In particular, the optimal threshold for starting RRT remains uncertain. Early initiation may lead to more rapid correction of electrolyte and metabolic derangements, mitigate fluid overload and prevent serious complications but has to be balanced against potential harm from vascular access, anticoagulation and haemodynamic instability.1 Early RRT also has resource implications and may result in patients receiving RRT unnecessarily. Data from observational studies and small clinical trials with variable criteria for ‘early’ and ‘late’ suggest that early initiation may be better, but results from randomised controlled trials (RCTs) are conflicting.2 The RCT by Zarbock et...




Coronary-artery bypass surgery plus medical therapy is associated with longer survival over 10 years than medical therapy alone in patients with ischaemic cardiomyopathy

2017-01-24T07:25:01-08:00

Commentary on: Velazquez EJ, Lee KL, Jones RH, et al.., STICHES Investigators. Coronary-Artery Bypass Surgery in Patients with Ischemic Cardiomyopathy. N Engl J Med 2016;374:1511–20 .

Context

The efficacy of coronary artery bypass grafting (CABG) in patients with ischaemic cardiomyopathy with low ejection fraction has long been controversial. However, few studies were available that compared the outcomes after CABG with medical therapy in those patients. These studies demonstrated long-term survival benefit of CABG compared with medical therapy alone. However, most of them were performed more than 40 years ago with small sample size before establishing current guideline-based medical therapy.1–3 Recently, the Surgical Treatment for Ischemic Heart Failure (STICH) study investigated whether CABG plus guideline-based medical therapy for ischaemic cardiomyopathy would improve survival compared with medical therapy alone.4 5 As a result, the STICH investigators reported that there was no...




Caloric restriction improves health-related quality of life in healthy normal weight and overweight individuals

2017-01-24T07:25:01-08:00

Commentary on: Martin CK, Bhapkar M, Pittas AG, et al.. Effect of calorie restriction on mood, quality of life, sleep and sexual function in healthy nonobese adults: the CALERIE 2 randomized clinical trial. JAMA Intern Med 2016;176:743–52 .

Context

Studies have demonstrated that caloric restriction (CR) increases longevity in animals and also decreases the risk of diabetes, cardiovascular disease and cancer in humans without obesity.1 2 It is hypothesised that these favourable CR effects may be related to a reduction in metabolism, reduced core temperature and lowered triiodothyronine(T3).3 While it is unlikely that studies will ascertain whether CR extends life, intermediate length studies may be able to determine the safety, tolerability and feasibility of CR and its effects on chronic disease development and biomarkers correlated with longevity.2 This study aimed to examine the sustained effects of a 25% CR on...




Weekly adalimumab significantly reduces the number of abscesses and inflammatory nodules in patients with moderate to severe hidradenitis suppurativa

2017-01-24T07:25:01-08:00

Commentary on: Kimball AB, Okun MM, Williams DA, et al.. Two phase 3 trials of adalimumab for hidradenitis suppurativa. N Engl J Med 2016;375:422–34 .

Context

Hidradenitis suppurativa (HS) is a painful, chronic inflammatory skin disease, characterised by the presence of inflamed nodules, abscesses, pustules, fistulas and scar tissue, usually located in the axillary and inguinal area. Treatment is difficult; most patients require a combination of surgical treatment and medical treatment. The clinical symptoms can be reduced considerably by using anti-inflammatory medication. Since 2001, several monoclonal antibodies have been tried in HS, including the tumour necrosis factor α (TNF-α) inhibitors infliximab, etanercept and adalimumab. Adalimumab is the first monoclonal antibody that was tested in large randomised placebo-controlled clinical trials.

Methods

In two double-blind, placebo-controlled multicentre trials (PIONEER I and II), patients were randomly assigned to 40 mg adalimumab weekly or placebo, for 12 weeks. In the second phase...




Pitfalls of administrative database analysis are evident when assessing the 'weekend effect in stroke

2017-01-24T07:25:01-08:00

Commentary on: Li L, Rothwell PM. Biases in detection of apparent "weekend effect" on outcome with administrative coding data: population based study of stroke. BMJ 2016;353:i2648 .

Context

Multiple studies attempt to clarify the role of weekend admissions in stroke.1 2 Recent studies have leveraged large populations in administrative databases to retrospectively evaluate hypotheses. While these studies disagree as to whether weekend admissions are associated with increased stroke mortality, concern exists regarding inherent limitations of administrative coding databases, including accuracy of patient and disease variables.3 Concern is justified, as coding inaccuracies unduly influence the study results. The Oxford Vascular Study (OXVASC), in contrast, contains detailed, comprehensive data prospectively recorded for all patients registered in Oxfordshire, the UK. The reviewed study admirably addresses administrative database accuracy, comparing data extracted from hospital coding with prospective OXVASC data, focusing on the accuracy of weekend versus...




Height of head centre of gravity predicts paediatric head injury severity in short-distance falls

2017-01-24T07:25:01-08:00

Commentary on: Hughes J, Maguire S, Jones M, et al.. Biomechanical characteristics of head injuries from falls in children younger than 48 months. Arch Dis Child 2016;101:310–315 .

Context

Short-distance falls are common events in infants and young children, and they are also a common false-case history for child physical abuse cases. Establishing whether a head injury to a child was the result of a short fall or physical abuse can be challenging during a forensic investigation. Current injury assessments on a possible child physical abuse case are principally based on clinical evidence and experts' personal experiences.1 2 The relationship between fall height and head injury severity—particularly at low heights—has been debated in the scientific literature. This study investigated the relationship between fall height and head injury severity using witnessed fall cases.

Methods

In this study, data from witnessed falls <3 m (10 feet)...




Cone depth increases risk of adverse obstetric outcomes following treatment for cervical preinvasive disease

2017-01-24T07:25:01-08:00

Commentary on: Kyrgiou M, Athanasious A, Paraskevaidi M, et al.. Adverse obstetric outcomes after local treatment for cervical preinvasive and early invasive disease according to cone depth: systematic review and meta-analysis. BMJ 2016;354:i3633 .

Context

A strong and consistent association between treatment for cervical disease and subsequent preterm birth has been established.1 The association with preterm birth is stronger when more aggressive forms of treatment (eg, knife cones) are considered.1 Several studies have shown a biological gradient, with a greater risk of preterm delivery with increasing amount of tissue removed.2 3 Two meta-analyses have assessed the importance of the comparison group when assessing the risk of preterm birth,4 5 but they did not consider the amount of tissue removed. This systematic review and meta-analysis examines the impact of various types of treatment for cervical preinvasive disease...




Consuming meals prepared at home more frequently appears to reduce the risk of type 2 diabetes, weight gain and obesity

2017-01-24T07:25:01-08:00

Commentary on: Zong G, Eisenberg DM, Hu FB, et al.. Consumption of meals prepared at home and risk of type 2 diabetes: an analysis of two prospective cohort studies. PLoS Med 2016;13:e1002052 .

Context

Many public health strategies include promotion of cooking at home as a method to improve diet, and reduce obesity and diseases related to diet and obesity. However, a recent systematic review found that the majority of existing studies on the relationships between home food preparation and diet and health outcomes are cross-sectional, raising the possibility of reverse causation.1 The literature is also confused by poor conceptualisation and operationalisation of ‘home food preparation’, with many studies focusing on the behaviour of cooking, rather than consumption of food cooked at home.

Methods

This longitudinal analysis of two prospective cohort studies from the USA examined associations between frequency of eating meals prepared at...




Whether neonatal phototherapy increases the risk of cancer in children is a disturbing unresolved issue

2017-01-24T07:25:01-08:00

Commentary on: Wickremasinghe AC, Kuzniewicz MW, Grimes BA, et al.. Neonatal phototherapy and infantile cancer. Pediatrics 2016;137:pii:e20151353 ; Newman TB, Wickremasinghe AC, Walsh EM, et al.. Retrospective cohort study of phototherapy and childhood cancer in Northern California. Pediatrics 2016;137:pii:e20151354 .

Context

Phototherapy (PT) has been widely used for decades to reduce the total serum bilirubin of neonates, and the belief that the benefits far outweigh the hazards may warrant reconsideration not only for preterm infants but also near term and term infants.1 Although not generally appreciated by paediatricians or neonatologists, the number needed to treat (NNT) with PT to prevent one term infant from reaching bilirubin levels that meet exchange transfusion guidelines may now exceed 1000,2 and recent studies have found that few term infants who reach these thresholds have adverse effects from bilirubin neurotoxicity.3–5 Thus, even rare...