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Evidence-Based Medicine recent issues



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Evidence-Based Medicine these 7 years: time for the editor to go on permanent sabbatical

2017-06-09T01:30:22-07:00

Seven years seems the right term for an editorship. It is a time for the land that has been sown and reaped to remain uncultivated for a while (see Exodus or Leviticus, The Bible)—time for a sabbatical. When I came on in 2010, Evidence-Based Medicine (EBM) was already well established (for 15 years, its adolescence)1 as was the field of EBM (>3 years earlier, its birth).2 At the beginning, the journal aimed to serve this ‘emerging clinical discipline by providing easier access to high-quality evidence that is ready for prime-time clinical application’. The journal scanned a list of 29 other journals regularly, re-reported articles published in another journal as half of its content and added coverage beyond internal medicine. In the subsequent decade, it had published ‘notebook jottings’ on EBM, some of which reported on codified practices in the field.3 But it was time for...




Grading evidence from test accuracy studies: what makes it challenging compared with the grading of effectiveness studies?

2017-06-09T01:30:22-07:00

Guideline panels need to process a sizeable amount of information to issue a decision on whether to recommend a health technology or not. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) is being frequently applied in guideline development to facilitate this task, typically for the synthesis of effectiveness research. Questions regarding the accuracy of medical tests are ubiquitous, and they temporally precede questions about therapy. However, literature summarising the experience of applying GRADE approach to accuracy evaluations is not as rich as one for effectiveness evidence. Type of study design (cross-sectional), two-dimensional nature of the performance measures (sensitivity and specificity), propensity towards a higher level of between-study heterogeneity, poor reporting of quality features and uncertainty about how best to assess for publication bias among other features make this task challenging. This article presents solutions adopted to addresses above challenges for judicious estimation of the strength of test accuracy evidence used to inform evidence syntheses for guideline development.




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

2017-06-09T01:30:22-07:00

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.




How good is the evidence to support primary care practice?

2017-06-09T01:30:22-07:00

Our goal was to determine the extent to which recommendations for primary care practice are informed by high-quality research-based evidence, and the extent to which they are based on evidence of improved health outcomes (patient-oriented evidence). As a substrate for study, we used Essential Evidence, an online, evidence-based, medical reference for generalists. Each of the 721 chapters makes overall recommendations for practice that are graded A, B or C using the Strength of Recommendations Taxonomy (SORT). SORT A represents consistent and good quality patient-oriented evidence; SORT B is inconsistent or limited quality patient-oriented evidence and SORT C is expert opinion, usual practice or recommendations relying on surrogate or intermediate outcomes. Pairs of researchers abstracted the evidence ratings for each chapter in tandem, with discrepancies resolved by the lead author. Of 3251 overall recommendations, 18% were graded ‘A’, 34% were ‘B’ and 49% were ‘C’. Clinical categories with the most ‘A’ recommendations were pregnancy and childbirth, cardiovascular, and psychiatric; those with the least were haematological, musculoskeletal and rheumatological, and poisoning and toxicity. ‘A’ level recommendations were most common for therapy and least common for diagnosis. Only 51% of recommendations are based on studies reporting patient-oriented outcomes, such as morbidity, mortality, quality of life or symptom reduction. In conclusion, approximately half of the recommendations for primary care practice are based on patient-oriented evidence, but only 18% are based on patient-oriented evidence from consistent, high-quality studies.




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

2017-06-09T01:30:22-07:00

Commentary on: Hamdy FC, Donovan JL, Lane JA, et al.. 10-Year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer. N Engl J Med 2016;375:1415–24.

Donovan JL, Hamdy FC, Lane JA, et al. Patient-reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer. N Engl J Med 2016;375:1425–37.

Context

Prostate cancer (PCA) remains a common and potentially fatal condition. Effective and safe treatment options are needed. However, few randomised trials have assessed the benefits and harms of radical prostatectomy (RPX), radiation therapy (XRT) and watchful waiting/observation to provide the evidence base for treating men with clinically localised PCA. The Scandinavian Prostate Cancer Group-4 (SPCG-4) trial randomised 695 men diagnosed in the pre-prostate-specific antigen (PSA) era, most had palpable disease, to surgery or observation.1 After a median follow-up of 13.4 years, surgery reduced PCA deaths by 44% (HR=0.56; 95% CI 0.41 to 0.77; absolute risk...




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

2017-06-09T01:30:22-07:00

Commentary on: Reiss-Brennan B, Brunisholz KD, Dredge C, et al.. Association of integrated team-based care with health care quality, utilization, and cost. JAMA 2016;316:826–34.

Context

Team-based care (TBC) is commonly seen as a foundational element of successful practice transformation.1 Mental health integration in primary care has been shown to be clinically effective, but historically limited by organisational and financial barriers.2 As a fully integrated health delivery system, Intermountain Healthcare has internally developed and implemented its Intermountain Mental Health Integration (MHI) programme since 2000. This study compares measures of healthcare quality and usage as well as actual payments received and programme investment costs for patients receiving care in TBC/mental health integration practices versus those in usual care.

Methods

This was a retrospective, longitudinal, cohort study of adult patients (n=113 452) who received primary care at Intermountain Healthcare primary care practices. Patients ≥18 years old...




Early invasive strategy in patients with non-ST segment elevation acute coronary syndrome delays death or MI by 18 months

2017-06-09T01:30:22-07:00

Commentary on: Wallentin L, Lindhagen L, Ärnström E, et al. Early invasive versus non-invasive treatment in patients with non-ST-elevation acute coronary syndrome (FRISC-II): 15 year follow-up of a prospective, randomised, multicentre study. Lancet 2016;388:1903–11.

Context

The role of coronary arteriography in patients with non-ST segment elevation acute coronary syndrome is controversial. Many cardiologists advocate a ‘routine invasive strategy’, which comprises coronary arteriography within a few days of presentation and myocardial revascularisation determined by the angiographic findings, but this exposes patients to procedural risks and incurs significant costs. Other clinicians favour a ‘selective invasive strategy’, with coronary arteriography reserved for patients with recurrent myocardial ischaemia.

Randomised trials of these treatment strategies suggest that a routine invasive strategy reduces the risk of recurrent ischaemia and death or recurrent myocardial infarction over 5 years.1 In the RITA-3 trial, a routine invasive strategy was also associated with lower cardiovascular and total mortality...




A clinical risk score to predict the incidence of postpartum venous thromboembolism

2017-06-09T01:30:22-07:00

Commentary on: Sultan AA, West J, Grainge MJ, et al.. Development and validation of risk prediction model for venous thromboembolism in postpartum women: multinational cohort study. BMJ 2016;355:i6253.

Context

Around 1 in 1000 postpartum women suffers from venous thromboembolism (VTE).1 The occurrence of deep vein thromboses (DVT), often found in proximal veins, may affect long-term quality of life,2 and pulmonary embolisms (PE) are a leading cause of direct maternal death in this very healthy population. Given the overall low absolute risk of VTE, as well as the cost of thromboprophylaxis and its possible side-effects, the use of prophylactic heparin is unreasonable if given universally, but should be tailored to individual risks. The aim of this study was to generate a validated risk-assessment model or prediction tool to estimate the absolute risk of postpartum VTE in individual women.

Methods

Using two population-based...




Close contact casting may result in similar outcomes compared with plate fixation for unstable ankle fractures in patients over 60 years old

2017-06-09T01:30:22-07:00

Commentary on: Willett K, Keene DJ, Mistry D, et al.. Close contact casting vs surgery for initial treatment of unstable ankle fractures in older adults: a randomized clinical trial. JAMA 2016;316:1455–63.

Context

Surgery has been considered the mainstay of treatment for unstable ankle fractures. Early mobilisation and weight bearing is possible with stable anatomic fracture fixation (open reduction internal fixation (ORIF)). Surgery also increases the risk of wound problems. This study compared outcomes among older adults with ankle fractures who received ORIF versus close contact casting.

Methods

This study was prospective, powered and randomised to determine the outcomes at 6 months of adults aged 60 years or older using the Olerund-Molander Ankle Score (OMAS). Patients were randomised to casting or surgery (ORIF) in a 1:1 ratio. The surgeons were trained in the casting technique before the study. If casting failed and the patient underwent ORIF, the patient...




Clinical failure is more common in young children with acute otitis media who receive a short course of antibiotics compared with standard duration

2017-06-09T01:30:22-07:00

Commentary on: Hoberman AParadise JLRockette HE. Shortened antimicrobial treatment for acute otitis media in young children. N Engl J Med 2016;375:244656.

Context

Acute otitis media (AOM) is a leading cause of doctor consultations and antibiotic prescriptions in young children.1 Strategies to reduce antibiotic prescribing for AOM and thereby the emerging spread of antimicrobial resistance have focused on watchful waiting and delayed prescription, in particular in children over 2 years.2 An alternative strategy to combat antimicrobial resistance is to reduce the duration of antibiotic treatment. So far, the evidence to support this strategy in young children with AOM has been incomplete.3

Methods

Hoberman and colleagues recruited 520 children from an academic children's hospital and affiliated paediatric practices and a private paediatric research practice in the USA. Children were aged 6–23 months and diagnosed with AOM based on the following criteria: (1) recent...




Abdominal electroacupuncture demonstrates an increase in complete spontaneous bowel movements

2017-06-09T01:30:22-07:00

Commentary on: Liu Z, Yan S, Wu J, et al. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med 2016;165:761–9.

Context

Chronic idiopathic constipation has been reported in ~11% of south Asian populations.1 Pharmacological agents, such as the 5-HT4 receptor agonist, prucalopride, result not only in increased spontaneous bowel movements (SBMs) but also in increased adverse events in the Asian population.2 Therefore, alternative therapies are being researched. Multiple abdominal points (‘acupoints’) have been associated with stimulation of parasympathetic nerves (ST25, ST37, BL25, ST36 and TE6).3 A recent report evaluated the effects of electroacupuncture (EA) applied at ST25, SP14 and ST37 on severe chronic constipation (CC) in a randomised controlled trial (RCT).

Methods

This was a randomised, parallel, sham-controlled trial comparing EA with sham acupuncture in patients with severe CC defined by Rome III criteria (≤2 complete SBM (CSBM)/week). After a 2-week...




Intensive blood pressure lowering provides no additional benefits and results in more adverse events

2017-06-09T01:30:22-07:00

Commentary on: Qureshi AI, Palesch YY, Barsan WG, et al. Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage. N Engl J Med 2016;375:1033-43.

Context

Elevated blood pressure (BP) in acute intracerebral haemorrhage (ICH) is common and associated with poor outcome. High BP causes an expansion of the intracerebral haematoma, and the ‘Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial’ (INTERACT2) showed that moderate BP lowering <140 mm Hg is safe and likely to reduce death and major disability.1 The results of the INTERACT2 trial changed current guidelines.2 However, it is unclear whether very intensive BP lowering is of any further benefit for patients with ICH.

Methods

The ‘Antihypertensive Treatment of Acute Cerebral Hemorrhage 2’ (ATACH-2) trial was a randomised, multicentre, open-label trial of intensive versus standard BP lowering in patients with ICH. Patients with ICH volume <60 cm3, Glasgow Coma Scale >5 and systolic BP (SBP)...




High-intensity exercise offers no additional benefit to moderate-intensity exercise in reducing liver fat in patients with non-alcoholic fatty liver disease

2017-06-09T01:30:22-07:00

Commentary on: Zhang HJ, He J, Pan LL, et al. Effects of moderate and vigorous exercise on non-alcoholic fatty liver disease: a randomized clinical trial. JAMA Intern Med 2016;176:1074–82.

Context

Non-alcoholic fatty liver disease (NAFLD) is associated with an increased risk of liver morbidity and mortality, type 2 diabetes mellitus and cardiovascular disease (CVD). Lifestyle modification is the mainstay of treatment, with uncertainty regarding the effectiveness of drug therapy for patients with NAFLD.1 Exercise intervention studies demonstrate that exercise effectively reduces liver fat, even in the absence of significant weight loss. In free-living individuals, higher exercise frequency is associated with a lower risk NAFLD and higher rates of resolution of existing NAFLD over 5 years of follow-up.2 However, widespread implementation of exercise as a therapeutic modality is challenging, with a high prevalence of sedentary behaviour/physical inactivity in the UK. We need to better define the...




Possible protective effect of prenatal omega-3 long-chain polyunsaturated fatty acids supplementation on persistent wheeze and asthma in early childhood

2017-06-09T01:30:22-07:00

Commentary on: Bisgaard H, Stokholm J, Chawes BL, et al. Fish oil-derived fatty acids in pregnancy and wheeze and asthma in offspring. N Engl J Med 2016;375(26):2530–9.

Context

The incidence of asthma and wheezing disorders in developed countries has increased in recent decades.1 Profound changes in the type of fat consumed, particularly an increased intake of omega-6 (-6) relative to omega-3 (-3) fatty acids, parallel the increasing prevalence of asthma and other inflammatory diseases, leading to the hypothesis that imbalance of fats may be causally related. This randomised controlled trial (RCT) investigates the effect of prenatal -3 long-chain polyunsaturated fatty acids (LCPUFA) fish oil supplementation compared with control on symptoms of wheeze or asthma in the offspring between birth and 3 to 5 years of age.

Methods

In this double-blind, placebo-controlled, parallel group RCT, pregnant women were randomised to receive either 2.4 g/day of -3 LCPUFA...




Oral antibiotics are as effective as intravenous antibiotics for postdischarge treatment of complicated pneumonia in children

2017-06-09T01:30:22-07:00

Commentary on: Shah SS, Srivastava R, Wu S, et al. Intravenous versus oral antibiotics for postdischarge treatment of complicated pneumonia. Pediatrics 2016;138:e20161692.

Context

In children, complicated pneumonia implies pneumonia infection that is associated with pleural effusion or empyema.1 Initial management involves use of parenteral broad spectrum antibiotics to cover the most common organisms1; thoracotomy or chest tube insertion may be indicated if there is no response to antibiotic therapy, or if there is significant respiratory difficulty. Most national guidelines do not specify the preferred route of antibiotic therapy for postdischarge treatment. For instance, British guidelines recommend a switch to oral antibiotics if there is clear evidence of improvement,2 while American guidelines are non-specific.3 This retrospective study compared the benefits and harms of intravenous versus oral antibiotic therapy for treatment of complicated pneumonia in children postdischarge.

Methods

This was...




Conduct and reporting of a vertebroplasty trial warrants critical examination

2017-06-09T01:30:22-07:00

Commentary on: Clark W, Bird P, Gonski P, et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet 2016;388:1408–16.

Context

Percutaneous vertebroplasty was widely used in patients with symptomatic acute vertebral compression fractures until two placebo randomised controlled trials (RCTs) published in 2009 questioned its efficacy and safety.1 2 Consistent results across both trials indicated vertebroplasty was no more effective than placebo, while a combined individual patient metaanalysis failed to show an advantage for vertebroplasty for participants with fracture ≤6 weeks.3 Despite these data, some have suggested that there may be subgroups that would benefit from vertebroplasty.

Methods

VAPOUR was a multicentre participant-blinded and outcome assessor-blinded RCT assessing the efficacy of vertebroplasty versus placebo in 120 participants with acute (<6 weeks), severely painful vertebral compression fractures.4 The primary outcome was...




Resumption of anticoagulation after major bleeding decreases the risk of stroke in patients with atrial fibrillation

2017-06-09T01:30:22-07:00

Commentary on: Hernandez I, Zhang Y, Brooks MM, et al. Anticoagulation use and clinical outcomes after major bleeding on dabigatran or warfarin in atrial fibrillation. Stroke 2017;48:159–66.

Context

Anticoagulation decreases the risk of stroke and other thromboembolic complications in patients with atrial fibrillation (AF) at the cost of an increased risk of major bleeding. If patients experience an anticoagulation-related major bleeding complication, the clinician faces the dilemma of whether to resume anticoagulation treatment or not. Evidence-based recommendations are lacking,1 and there is a wide variation in treatment of these patients, with anticoagulants, antiplatelets or no anticoagulation at all, while there is even less experience with non-vitamin K oral anticoagulants (NOACs), such as dabigatran. This study aimed to (1) evaluate anticoagulation use after a major bleeding event on dabigatran or warfarin and (2) compare outcomes between patients discontinuing anticoagulation and those restarting dabigatran or warfarin.

Methods

This was...




In patients with intracerebral haemorrhage and concomitant atrial fibrillation, optimal timing of reinitiating anticoagulants may be 7-8 weeks after ICH

2017-06-09T01:30:22-07:00

Commentary on: Pennlert J, et al. Optimal timing of anticoagulant treatment after intracerebral haemorrhage in patients with atrial fibrillation. Stroke 2017:48;314–320.

Context

In patients with intracerebral haemorrhage (ICH) and a concomitant diagnosis of atrial fibrillation (AF), the clinical dilemma arises whether anticoagulant treatment should be (re)started and when.1 In the absence of results from randomised controlled trials, guidelines provide no firm recommendations. Several observational studies have suggested that reintroduction of oral anticoagulants may be associated with a reduction in thrombotic events and all-cause mortality.2 3 Evidence regarding the optimal timing of reinitiating anticoagulant treatment is even scarcer.

Methods

This was a nationwide observational study of 2619 patients with ICH (mean age 78.0 years) with a concomitant diagnosis of AF identified in the Swedish stroke register, Riksstroke, who survived hospital discharge. Patient characteristics, prescribed drugs after ICH and outcomes were extracted from...




Stroke rates vary substantially across cohorts of patients with atrial fibrillation

2017-06-09T01:30:22-07:00

Commentary on: Quinn GRSeverdija ONChang Y. Wide variation in reported rates of stroke across cohorts of patients with atrial fibrillation. Circulation 2017;135:208–19.

Context

Oral anticoagulants (OACs) substantially reduce stroke risk in patients with atrial fibrillation (AF); however, they remain globally underused.1 One of the main reasons is the difficulty in stratifying AF-related ischaemic stroke risk at the individual patient level.1 2 Among scores stratifying AF-related stroke risk, CHA2-DS2-Vasc prevails in most recent international AF guidelines.3 4 Still, it remains unknown whether AF-related stroke risk is stable across regions, international cohorts or within specific CHA2-DS2-Vasc score strata.

Methods

This systematic review included only studies reporting ischaemic stroke rates for patients with AF not on OACs, and assessed the annual stroke risk among prospective versus retrospective cohort studies and clinical trials. Cohort study quality and heterogeneity were...




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

2017-06-09T01:30:22-07:00

Commentary on: Yuan C, Gaskins AJ, Blaine AI, et al. Association between cesarean birth and risk of obesity in offspring in childhood, adolescence, and early adulthood. JAMA Pediatr 2016;170:e162385.

Context

Since 2008, several observational studies have reported an association between caesarean section (CS) and offspring obesity. The underlying biological mechanism hypothesised to explain this association is that children born via CS lack exposure to the maternal vaginal flora, resulting in colonisation of the gut with flora that increase energy harvesting from food, thereby contributing to the development of obesity. Maternal pre-pregnancy weight confounds this association, as obesity in the mother is associated with CS and offspring obesity. Not all previous studies were able to adjust for maternal pre-pregnancy weight, but a recent systematic review showed that in studies that were able to adjust for this confounder, there remained a statistically significant association of CS with obesity in the...




Among opioid-naive patients receiving opioids, more intensive opioid prescribing in the first month is associated with transition to long-term opioid use

2017-06-09T01:30:22-07:00

Commentary on: Deyo RA, Hallvik SE, Hildebran C, et al. Association between initial opioid prescribing patterns and subsequent long-term use among opioid-naïve patients: a statewide retrospective cohort study. J Gen Intern Med 2017;32(1):21-7.

Context

A recent systematic review of long-term opioid use for chronic pain found that evidence is lacking to support benefit from long-term opioid therapy, and evidence supports a dose-dependent risk of opioid-related harms including overdose and death.1 Despite the evidence, an estimated 5 to 8 million Americans receive long-term opioid therapy.2 Understanding the transition from acute or episodic use of opioids to long-term opioid use may help design interventions to reduce the incidence of long-term opioid use. This study sought to analyse the association between prescribing patterns in the first 30 days of opioid receipt among formerly opioid-naive subjects and transitioning to long-term opioid use.

Methods

This retrospective cohort study used opioid...




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

2017-06-09T01:30:22-07:00

Commentary on: Grzeskowiak LE, Morrison JL, Henriksen TB, et al. Prenatal antidepressant exposure and child behavioural outcomes at 7 years of age: a study within the Danish National Birth Cohort. BJOG 2016;123:1919–28.

Context

The effect of prenatal antidepressant exposure or untreated maternal depression on child behaviour is an emerging field of research in perinatal psychiatry. This study attempts to clarify the impact of prenatal antidepressant exposure on long-term child outcomes, accounting for antenatal maternal factors, including depression.

Methods

This study was conducted using data from 49 178 mother–child dyads enrolled in the Danish National Birth Cohort—a nationwide longitudinal follow-up study of pregnant women and their children. The overall cohort includes more than 100 000 women who were pregnant between 1996 and 2002. Maternal depression and medication use was assessed via self-report using computer-assisted telephone interviews conducted during pregnancy. Children were categorised as: born to depressed women who took...




Urine concentration should be taken into account when interpreting pyuria in infants

2017-06-09T01:30:22-07:00

Commentary on: Chaudhari PP, Monuteaux MC, Bachur RG, et al. Urine concentration and pyuria for identifying UTI in infants. Pediatrics 2016;138:e20162370.

Context

The relationship between pyuria and true urinary tract infection (UTI) remains controversial. Most studies have assessed pyuria using manual microscopy in centrifuged urine. However, standard practice at most centres now involves automated urinalysis of uncentrifuged urine, thus pyuria in dilute samples may have more significance than pyuria in concentrated urine samples. It may therefore be important to consider the possible impact of urine concentration on the significance of white cell counts (WCC) or leucocyte esterase (LE) assessment.

Methods

This was a retrospective study of routinely collected data from infants aged less than 3 months with suspected UTI, who presented to a busy US emergency department (ED) over 5 years. Automated urinalysis and culture were available for each eligible child. UTI was defined as ≥50 000 colony-forming units (CFU)/mL of a pathogenic organism,...




Criticisms of the VAPOUR trial in a recent commentary are unsubstantiated and incorrect

2017-06-09T01:30:22-07:00

We are concerned by commentary1 about the VAPOUR trial2 written by authors of two previous masked vertebroplasty trials.3 4 Having participated in the larger of these trials, INVEST,3 we adopted similar trial methodology in VAPOUR but restricted patient inclusion criteria to fractures <6 weeks duration causing severe pain (table 1).

The commentary speculates that trial procedures were inadequately masked because patients could not smell polymethyl methacrylate (PMMA). We replicated the placebo used in INVEST with the exception that the selected PMMA kit emitted no odour, and lidocaine was injected into the subcutaneous rather than periosteal space, precluding therapeutic effect. Intravenous sedation, and the verbal and tactile cues suggesting vertebroplasty was being performed, were identical to INVEST.

More patients in the vertebroplasty group than placebo group correctly guessed their assigned intervention and overwhelmingly nominated pain reduction as the principle reason for...