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Evidence-Based Medicine current issue



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Meta-analysis using individual participant data from randomised trials: opportunities and limitations created by access to raw data

2017-10-04T07:27:03-07:00

Meta-analysis based on individual participant data (IPD), often described as the ‘gold standard’ for effectiveness evidence synthesis, is increasingly being deployed despite being more resource intensive than collating study-level results. Its professed virtues include the ability to incorporate unreported data and to standardise variables and their definitions across trials. In reality, the unreported data, although present in shared datasets, might still not be usable in the analysis. The characteristics of trial participants and their outcomes may be too diversely captured for harmonisation and too time and resource consuming to standardise. Embarking on an IPD meta-analysis can lead to unanticipated challenges which ought to be handled with pragmatism. The aim of this article is to discuss the opportunities created by access to IPD and the practical limitations placed on such meta-analyses, using an international IPD meta-analysis of trials on the effect of lifestyle interventions in pregnancy as an example. Despite the increasing uptake of IPD meta-analysis, they encounter old problems shared by other research methods. When embarking on IPD meta-analysis, it is essential to evaluate the trade-offs between the ambitions, and what is achievable due to constraints imposed by the condition of collected IPD. Furthermore, incorporation of aggregate data from trials where IPD was not available should be a mandatory sensitivity analysis that makes the evidence synthesis up-to-date.




USPSTF is unable to recommend for or against lipid screening to identify multifactorial dyslipidaemia in childhood: no recommendation is not without consequences

2017-10-04T07:27:03-07:00

Paediatric lipid screening has been recommended for decades to identify youth at increased risk for early atherosclerotic disease but is controversial and not universally adopted. A 2016 review by the US Preventive Services Task Force (USPSTF) found inadequate evidence to recommend for or against lipid screening in childhood. In this Perspective article, we examine this controversial and important topic more broadly. We consider whether the USPSTF framework is asking the right questions, and whether the answers to these questions should be valued equally, whether the USPSTF questions are answerable and by what types of evidence and whether the burden of proof is appropriate. We argue that using a broader framework that includes the magnitude of potential benefits and harms, considering more types of evidence beyond randomised controlled trials, and more fully incorporating patient and parent perspectives could lead to more practical and more widely applicable guidance for practitioners, guide future research priorities and be more inclusive of patient priorities.




What does expert opinion in guidelines mean? a meta-epidemiological study

2017-10-04T07:27:03-07:00

Guidelines often use the term expert opinion (EO) to qualify recommendations. We sought to identify the rationale and evidence type in EO recommendations. We searched multiple databases and websites for contemporary guidelines published in the last decade that used the term EO. We identified 1106 references, of which 69 guidelines were included (2390 recommendations, of which 907 were qualified as EO). A rationale for using EO designation was not provided in most (91%) recommendations. The most commonly cited evidence type was extrapolated from studies that did not answer guideline question (40% from randomised trials, 38% from observational studies and 2% from case reports or series). Evidence extrapolated from populations that were different from those addressed in the guideline was found in 2.5% of EO recommendations. We judged 5.6% of EO recommendations as ones that could have been potentially labelled as good practice statements. None of the EO recommendations were explicitly described as being solely dependent on the clinical experience of the panel. The use of EO as a level of evidence in guidelines remains common. A rationale for such use is not explicitly provided in most instances. Most of the time, evidence labelled as EO was indirect evidence and occasionally was very low-quality evidence derived from case series. We posit that the explicit description of evidence type, as opposed to using the label EO, may add clarity and transparency and may ultimately improve uptake of recommendations.




Quality of reporting of harms in randomised controlled trials of pharmacological interventions for rheumatoid arthritis: a systematic review

2017-10-04T07:27:03-07:00

Background

The quality of reporting of harms data in randomised controlled trials (RCTs) has been reported to be suboptimal. Rheumatoid arthritis (RA) has seen a massive growth in novel pharmacotherapies in the last decade.

Objective

The aim of this study was to assess the quality of reporting of harms-related data in RCTs evaluating pharmacological interventions for RA according to the CONSORT (Consolidated Standards of Reporting Trials) statement on harms reporting extension.

Study selection

RCTs published between January 2011 and August 2016 in the five highest impact factor journals in general medicine and two in rheumatology subject categories as per 2015 Journal Citation Reports were included. Reports of secondary, supplementary or exploratory analyses of RCTs and non-inferiority trials were excluded. Two reviewers independently extracted data using a structured, pilot-tested, 18-item questionnaire developed based on CONSORT harms extension recommendations.

Findings

68 RCTs were included in the review. Out of a maximum harms reporting score of 18, the mean (SD) score was 8.51 (3.5) (range=0–15). More than half (56.5%) of the RCTs reported ≤50% of items and only three (4.3%) RCTs reported more than 70% (score ≥14) of the items. Multilinear regression analyses found that region of trial origin (p=0.01), sample size (p=0.001) and whether the study was a long-term extension of a trial or not (p=0.04) were independent predictors associated with higher total harms reporting score.

Conclusions

The adherence to CONSORT harms extension was poor in recently published RCTs of pharmacological interventions for RA. There is a need to improve quality of harms reporting in RCTs to allow transparent and balanced assessment of the benefit-risk ratio in clinical decision making.




Longer screening intervals are recommended following a negative HPV test in primary cervical screening

2017-10-04T07:27:03-07:00

Commentary on: Dijkstra MG, van Zummeren M, Rozendaal L, et al. Safety of extending screening intervals beyond five years in cervical screening programmes with testing for high-risk human papillomavirus: 14-year follow-up of population-based randomised cohort in the Netherlands. BMJ 2016;355:i4924.

Context

The cervical screening programmes in the UK and the Netherlands are replacing cytology by human papillomavirus (HPV) testing. In the Netherlands, women will be screened routinely at ages 30, 35, 40, 50 and 60 years. In the UK, a decision on screening frequency has yet to be made by the National Screening Committee. Currently British women are screened with cytology every 3 years at ages 25–49 and every 5 years at ages 50–64. Pooled results of four randomised controlled trials in Europe showed that HPV testing reduces cervical cancer risk.1 The British ARTISTIC trial2 and several other studies have also shown that it gives longer protection for...




Haem iron and nitrate/nitrite account for much of the mortality increase associated with red meat consumption

2017-10-04T07:27:03-07:00

Commentary on: Etemadi, A, Sinha R, Ward MH, et al. Mortality from different causes associated with meat, heme iron, nitrates, and nitrites in the NIH-AARP Diet and Health Study: population based cohort study. BMJ 2017;357:j1957.

Context

The International Agency for Research on Cancer categorised processed meat as carcinogenic to humans in 2015.1 High red and processed meat consumption is positively associated with risk of cardiovascular disease and type 2 diabetes as well as overall mortality.2 Usually the intake of processed red meat is found to be more strongly associated with disease outcomes than unprocessed red meat, which is thought to be due to preservation methods such as salting, curing and smoking, increasing the concentration of potentially hazardous substances in meat.3

Methods

In the US National Institutes of Health-American Association of Retired Persons (NIH-AARP) Diet and Health Study, more than half a million participants were recruited in...




Value of screening for and treating pre-diabetes is reduced by low test accuracy and indirect evidence of impact on patient important outcomes

2017-10-04T07:27:03-07:00

Commentary on: Barry E, Roberts S, Oke J, et al. Efficacy and effectiveness of screen and treat policies in prevention of type 2 diabetes: systematic review and meta-analysis of screening tests and interventions. BMJ 2017;356:i6538.

Context

Type 2 diabetes is a major cause of morbidity and mortality. Hoping to reduce the burden of diabetes on people and societies, guidelines have recommended screening for hyperglycaemia in healthy population.1 These recommendations assume that early detection and intervention can prevent the morbimortality associated with type 2 diabetes and its complications.1 The systematic review by Barry et al sought to evaluate the accuracy of screening and the efficacy of early intervention (lifestyle or metformin) to prevent type 2 diabetes1.

Methods

They conducted a rigorous systematic review of the published literature until June 2016. They then conducted two meta-analyses. The first one, a bivariate random-effects model meta-analysis, summarised...




Caffeine does not increase the arrhythmic burden in patients with heart failure and left ventricular systolic dysfunction

2017-10-04T07:27:03-07:00

Commentary on: Zuchinali P, Souza GC, Pimentel M, et al. Short-term effects of high-dose caffeine on cardiac arrhythmias in patients with heart failure: a randomized clinical trial. JAMA Intern Med 2016;176:1752–1759.

Context

Caffeine is a major component of some of the most widely consumed beverages, such as coffee. The role of caffeine in arrhythmias has always been controversial and the impact of caffeine on patients at high risk of arrhythmias it is not established.

Methods

This was a single-centre double-blinded randomised controlled trial (RCT) comparing the effect of caffeinated coffee (capsules with 100 mg of caffeine given hourly with decaffeinated coffee until 500 mg) and decaffeinated coffee (placebo lactose capsules) in patients with chronic heart failure (HF), New York Heart Association (NYHA) classes between I and III and left ventricular (LV) ejection fraction (LVEF) <45%. The trial had a cross-over design with an initial 1 week washout period before the administration of interventions and...




In stable COPD, long-acting muscarinic antagonist plus long-acting beta-agonists resulted in less exacerbations, pneumonia and larger improvement in FEV1 than long-acting beta-agonists plus inhaled corticosteroids

2017-10-04T07:27:03-07:00

Commentary on: Horita N, Goto A, Shibata Y, et al. Long-acting muscarinic antagonist (LAMA) plus long-acting beta-agonist (LABA) versus LABA plus inhaled corticosteroid (ICS) for stable chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev 2017;2:CD012066.

Context

The Global Initiative for Chronic Obstrictove Lung Disease 2017 report recommends the use of long-acting muscarinic antagonist (LAMA) + long-acting beta-agonist (LABA), or alternatively LABA + inhaled corticosteroid (ICS), in patients with chronic obstructive pulmonary disease (COPD) at risk of exacerbations regardless of the entity of symptoms.1 However, it does not specify whether it is preferable to start with LAMA+LABA rather than LABA+ICS. In fact, no firm conclusions can be drawn from the current literature.

Methods

The aim of this study was to compare the benefits and harms of LAMA+LABA versus LABA+ICS in the treatment of COPD. The authors conducted a meta-analysis of studies published up to June 2016, including individual randomised controlled trials,...




CETP inhibition improves the lipid profile but has no effect on clinical cardiovascular outcomes in high-risk patients

2017-10-04T07:27:03-07:00

Commentary on: Lincoff AM, Nicholls SJ, Riesmeyer JS, et al. Evacetrapib and cardiovascular outcomes in high-risk vascular disease. N Engl J Med 2017;376:1933–42.

Context

High-density lipoprotein (HDL) cholesterol (HDL-C) is a robust predictor of cardiovascular disease (CVD) events; however, research into both rare monogenic HDL disorders and Mendelian randomisation studies of dysfunctional traits associated with HDL-C demonstrate that this biomarker is not involved in the causal pathway for atherosclerosis.1 Small-effect variants in the gene encoding cholesteryl ester transfer protein (CETP) associate with higher HDL-C and lower myocardial infarction rates, whereas large-effect variants associate with reduced survival. CETP loss-of-function variants also associate with low levels of low-density lipoprotein (LDL) cholesterol (LDL-C), which confounds the attribution of the atheroprotective effect of CETP-mediated HDL changes.

Small molecules that inhibit CETP activity have been previously investigated in two randomised clinical trials of CVD outcomes.2 3 Treatment with...




Early renin-angiotensin system inhibition induced renal deterioration may be a predictor for long-term cardiorenal outcomes

2017-10-04T07:27:03-07:00

Commentary on: Schmidt M, Mansfield KE, Bhaskaran K, et al. Serum creatinine elevation after renin–angiotensin system blockade and long term cardiorenal risks: cohort study. BMJ 2017;356: j791.

Context

An increase in serum creatinine level may occur in the first 2 weeks that follow ACE inhibitor (ACEI)/angiotensin receptor blocker (ARB) therapy as a consequence of lowering intraglomerular pressure. Such renal impairment at baseline should stabilise within 2–4 weeks assuming normal volume and sodium intake. Renal function might deteriorate further when increasing the dose of diuretics, initiation of non-steroidal anti-inflammatory drugs (NSAIDs) or development of volume depletion from non-diuretic-induced causes such as gastroenteritis.1 Most guidelines recommend monitoring and stopping the treatment, if there is a creatinine increase of 30% or more. Recent studies have shown that ACEI and ARBs may be particularly effective in lowering the incidence of cardiovascular events.2

Methods

This study examined the incidence of cardiorenal events...




Antibiotic utilisation in very low birth weight infants without sepsis or necrotising enterocolitis is associated with multiple adverse outcomes

2017-10-04T07:27:03-07:00

Commentary on: Ting JY, Synnes A, Roberts A, et al. Association Between Antibiotic Use and Neonatal Mortality and Morbidities in Very Low-Birth-Weight Infants Without Culture-Proven Sepsis or Necrotizing Enterocolitis. JAMA Pediatr 2016;170:1181–1187.

Context

Concerns about antibiotic overuse have been raised since the 1940s, largely driven by worries about antibiotic resistance and the limited development pipeline for new antimicrobials.1 More recently, prolonged antibiotic exposure has been associated with adverse outcomes in preterm infants, including sepsis, necrotising enterocolitis and mortality.2 3 Paralleling these findings has been the rapid increase in our knowledge of the importance of the gut microbiome in health and disease,4 one that is substantially altered in infancy by antimicrobial exposure.5 Understanding the relationship between antimicrobial exposure among patients without definitive indications for treatment and adverse outcomes may support and stimulate stewardship efforts to reduce inappropriate use.

...



Serial transvaginal cervical length measurements and quantitative vaginal fetal fibronectin concentrations did not predict spontaneous preterm birth in low-risk nulliparous women

2017-10-04T07:27:03-07:00

Commentary on: Esplin MS, Elovitz MA, Iams JD, et al. Predictive accuracy of serial transvaginal cervical lengths and quantitative vaginal fetal fibronectin levels for spontaneous preterm birth among nulliparous women. JAMA 2017;317:1047–1056.

Context

Approximately 10% of pregnancies in the USA are delivered preterm, with two-thirds being spontaneous.1 While the single greatest risk factor for preterm birth (PTB) is a history of PTB, about 40% of pregnancies occur in nulliparous women. Identifying nulliparas who are most at risk for spontaneous PTB would allow for new approaches to lower the PTB rate. Two strategies have been promoted to identify women at high risk for PTB, including serial cervical length (CL) measurements and quantitative fetal fibronectin (FFN) concentrations. A short cervix has been shown to place women with a prior PTB at high risk for subsequent PTB and some authorities advocate performing transvaginal CL measurements in all pregnant women.




Antenatal corticosteroid administration between 24 hours and 7 days before extremely preterm delivery is associated with the lowest rate of mortality

2017-10-04T07:27:03-07:00

Commentary on: Norberg H, Kowalski J, Maršál K, et al. Timing of antenatal corticosteroid administration and survival in extremely preterm infants: a national population-based cohort study. BJOG 2017.  doi: 10.1111/1471-0528.14545. [Epub ahead of print 15 March 2017].

Context

Antenatal corticosteroids (ACS) reduce mortality in preterm infants.1 The association between timing of ACS and outcomes among extremely preterm infants has been sparsely investigated. In a recent large retrospective cohort study, higher odds for severe neonatal morbidity or mortality were seen in infants born at 24–33 weeks gestation with an administration-to-birth interval of ACS <1 or>7 days compared with 1–7 days.2 The objective of this study was to investigate the impact of ACS administration-to-birth interval on survival among extremely preterm infants.

Methods

This population-based cohort study used data collected prospectively from 2004 to 2007. Infants from 220/7 to 266/7 weeks gestation were categorised according to ACS exposure; none; <24 hours;...




Routine invasive strategies compared with conservative strategies do not lower the all-cause mortality in patients with non-ST elevation myocardial infarction and unstable angina

2017-10-04T07:27:03-07:00

Commentary on: Fanning JP, Nyong J, Scott IA, et al. Routine invasive strategies versus selective invasive strategies for unstable angina and non-ST elevation myocardial infarction in the stent era. Cochrane Database Syst Rev 2016:CD004815.

Context

Urgent coronary artery revascularisation with stents following an acute ST elevation myocardial infarction (MI) reduces mortality and the incidence of reinfarction. Current guidelines recommend the use of routine invasive strategies (RINVS) in patients with an acute non-ST elevation (NSTE) MI and in those with unstable angina (UA) with high-risk features. However, these guidelines are not necessarily evidence-based, and concern remains whether the RINVS is indeed superior to a selective invasive strategy (SINVS). This review and meta-analysis compares the benefits and harms associated with RINVS, in the stent era, with or without the use of glycoprotein (GP) IIb/IIIa receptor antagonists, with SINVS in patients with NSTEMI and UA.

Methods

This was a...




Over half of the patients who undergo adjustable gastric banding may require revision bariatric surgery

2017-10-04T07:27:03-07:00

Commentary on: Lazzati A, De Antonio M, Paolino L, et al. Natural history of adjustable gastric banding: lifespan and revisional rate. A nationwide study on administrative data on 53,000 patients. Ann Surg 2017;265:439–445.

Context

Worldwide obesity and its consequences are increasing at alarming rates.1 The only long-term proven treatment for obesity and its comorbidities is bariatric surgery.2 In 2008, the adjustable gastric band (AGB) was the most commonly performed bariatric procedure.3 Its early low complication rate and technically easy learning curve made it very popular; however, long-term complications have dogged this operation. Additionally, weight recidivism has led to band removal in 50% of patients4. This large French national retrospective study of prospectively collected data examines AGB survival and revision rates after band removal.

Methods

Discharge reports from a prospectively collected national database were reviewed. Cases of AGB insertions, removals and...




In localised prostate cancer, radical prostatectomy was associated with more sexual dysfunction and urinary incontinence than radiation or active surveillance

2017-10-04T07:27:03-07:00

Commentary on: Barocas DA, Alvarez J, Resnick MJ, et al. Association between radiation therapy, surgery, or observation for localized prostate cancer and patient-reported outcomes after 3 years. JAMA 2017;317:1126–1140.

Context

Widespread prostate cancer (PCa) screening has reduced PCa mortality, but also leads to overdiagnosis. After diagnosis, men are faced with a variety of management options that often have similar rates of cure but considerable risks to quality of life (QoL). The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study was developed to examine patient-reported outcomes measures (PROMs) after treatment for localised PCa.1

Methods

CEASAR is a prospective, longitudinal, population-based cohort study composed of patients from five Surveillance, Epidemiology, and End Results registries and the Cancer of the Prostate Strategic Urologic Research Endeavor registry. Eligibility criteria included age <80 years, prostate-specific antigen (PSA) <50 ng/mL, clinical stage T1–T2 and enrolment within 6 months of diagnosis. Primary outcome...




Meniscal resection may not benefit patients with traumatic meniscal tears

2017-10-04T07:27:03-07:00

Commentary on: Thorlund JB, Englund M, Christensen R, et al. Patient reported outcomes in patients undergoing arthroscopic partial meniscectomy for traumatic or degenerative meniscal tears: comparative prospective cohort study. BMJ 2017;356:j356.

Context

Arthroscopic partial meniscectomy (APM), a keyhole surgery where loose and fragmented pieces of a torn meniscus is removed, is one of the most common orthopaedic procedures performed. Over half of these are performed to treat a meniscus tear in a degenerative knee.1 However, several recent randomised trials have shown that APM is not superior to conservative treatment or placebo treating meniscus tears associated with a degenerative knee.2

Another ‘type’ of meniscus tear is a traumatic tear, the result of a traumatic knee injury of younger patient with otherwise healthy knee (with no degeneration). It has been a virtual unanimity among orthopaedic surgeons that patients with a traumatic tear require and benefit surgery (APM), contrary to those with...




Parent-delivered CBT may reduce intervention cost, but questions arise about effectiveness

2017-10-04T07:27:03-07:00

Commentary on: Creswell C, Violato M, Fairbanks H, et al. Clinical outcomes and cost-effectiveness of brief guided parent-delivered cognitive behavioural therapy and solution-focused brief therapy for treatment of childhood anxiety disorders: a randomised controlled trial. Lancet Psychiatry 2017;4:529–539.

Context

Psychological treatment of anxiety-related problems in youth has a rich history, dating back to Sigmund Freud’s work.1 After decades of clinical literature and scores of treatment outcome studies, a growing consensus formed among experts that cognitive–behavioural methods were especially effective, particularly the behavioural component involving graded exposure to feared stimuli. Delivery of this treatment approach by professional therapists can involve substantial cost, so the effort by Creswell and colleagues to investigate the use of parents to deliver the treatment has practical significance, and the study’s comparison between brief guided parent-delivered cognitive–behavioural therapy (GPD-CBT) and solution-focused brief therapy (SFBT) could add to the practical value of the study,...




Effectiveness of interventions based on implantable devices: meta-analyses or systematic reviews that fail to indicate which device brands were used

2017-10-04T07:27:03-07:00

We recently surveyed the literature on the effectiveness of three classes of implantable devices: (1) stents for carotid artery stenosis, (2) endovascular clips or coils for unruptured intracranial aneurysms and (3) prostheses for endovascular treatment of ruptured abdominal aneurysms. These three device-based interventions were selected because, at our Regional Health System, we were requested to undertake a series of competitive tenders for the procurement of these devices.

To synthetise the clinical literature on these topics, we adopted the empirical criterion of identifying—by expert consensus—the ‘best’ single meta-analysis or systematic review published over the past 36 months in the three areas. Hence, after a standard PubMed search, we selected the following articles: area (1): meta-analysis by Diao et  al,1 area (2): meta-analysis by Falk Delgado et al2 and area (3) meta-analysis by Badger et al.3 The expert opinion for this choice was that of the three authors of...




Comparing levels of evidence between Choosing Wisely and Essential Evidence Plus

2017-10-04T07:27:03-07:00

Although there has been increasing emphasis on the use of evidence to guide medical practice, using primary research studies to answer questions at the point-of-care is too time-consuming for most primary care physicians. Instead, physicians generally rely on secondary sources of evidence-based medicine from trusted curators.

The American Board of Internal Medicine Foundation’s Choosing Wisely campaign is an example of a secondary source of evidence focused on common medical practices that clinicians and patients should rethink in light of poor evidence of benefit, likelihood of harm, high incremental costs compared with alternatives, or a combination of these factors. Nearly every major medical organisation has submitted five or more recommendations with supporting evidence sources to the campaign.1

Unfortunately, there are indications that Choosing Wisely recommendations have not been widely adopted.2 One possible obstacle is concern about the adequacy of the evidence base for many of the...