'Consent' as it is understood in the medical context has to be asked from the patient and is the explicit agreement to waive a right to certain rules and norms which are normally expected in the treatment of other people and of ourselves as patients. Every surgical procedure would, without consent from the patient, be legally understood as assault and battery and the physician could be prosecuted for performing it. 'Informed consent' therefore in its most simple form means that the patient has received a good explanation about a medical procedure, understands what is happening to him or her and then can make an informed choice to accept or refuse, in the latter case the so called 'informed refusal.
EBM is by now the established way to conduct medical research and practice, sometimes more, sometimes less successful and always dependent on the user, both the physician and the patient. And although a lot of the criticism levelled at EBM can be refuted or EBM changed in a way that it is still true to its principles and still patient friendly, many patients are looking for alternatives to EBM and medicine in general. They are either dissatisfied by the way there are treated in hospitals and by conventional GPs, or they are slightly afraid of the treatments which can have side effects and whose ingredients lists contain long and hard-to-understand words.
Clebak, Karl T. MD, FAAFP; Nasir, Munima MD; Mendez-Miller, Megan DO; King, Rebecca MD; Malone, Michael MD Author Information
Commentary on : Elias WJ, Lipsman N, Ondo WG, et al. A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor. N Engl J Med 2016;375:730–9.[OpenUrl][1][PubMed][2] Propranolol and primidone significantly reduce tremor by around 60% in 50% of patients with essential tremor (ET). When medication is ineffective or causes intolerable side effects, neurosurgical intervention may be considered. Until recently, radiofrequency (RF) ablation or deep brain stimulation (DBS) of the ventralis intermedius (VIM) thalamic nucleus were the main surgical options. Gamma knife thalamotomy avoids a burrhole but delayed effects make intraoperative validation impossible.1 Recent technical advances have enabled transcranial delivery of high-intensity focused ultrasound to create a thalamotomy with MRI guidance and … [1]: {openurl}?query=rft.jtitle%253DN%2BEngl%2BJ%2BMed%26rft.volume%253D375%26rft.spage%253D730%26rft_id%253Dinfo%253Apmid%252F27557301%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=27557301&link_type=MED&atom=%2Febmed%2F22%2F2%2F64.atom
Commentary on: Hayes JF, Marston L, Walters K, et al. Adverse Renal, Endocrine, Hepatic, and Metabolic Events during Maintenance Mood Stabilizer Treatment for Bipolar Disorder: A Population-Based Cohort Study. PLoS Med 2016;13(8):e1002058.[OpenUrl][1] Bipolar disorder is most often severe and recurrent, requiring pharmacological maintenance treatment in combination with psychoeducation and/or other interventions.1 Evidence for the efficacy and tolerability of pharmacological treatment is primarily based on randomised controlled trials (RCTs). However, RCTs are usually characterised by a relatively short duration of follow-up and by relatively small sample sizes. Therefore, for detecting and evaluating rare and long-term side effects, large observational cohort studies have been conducted. Even though selection bias and confounding cannot be avoided in non-randomised studies, various approaches in terms of design and analysis are available for balancing the comparative groups and/or for confounder control, for example, case–control design, use of propensity score models or use of multivariate regression analysis. A study population of patients diagnosed with bipolar disorder in The Health Improvement Network database receiving at least one 28-day prescription of lithium, valproate, … [1]: {openurl}?query=rft.jtitle%253DPLoS%2BMed%26rft.volume%253D13%26rft.spage%253De1002058%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx
Commentary on: Welch HG, Prorok PC, O'Malley AJ, et al. Breast-cancer tumor size, overdiagnosis, and mammography screening effectiveness. N Engl J Med 2016;375:1438–47.[OpenUrl][1][CrossRef][2][PubMed][3] Since randomised trials demonstrated a reduction in breast cancer mortality with mammographic screening, such screening has become widespread in developed countries, and mortality from breast cancer has declined in recent decades.1 There is interest in quantifying the proportion of this mortality reduction attributable to screening and that attributable to improvements in treatment. This paper reported on analysis of breast cancer incidence and case death in women aged 40 years and over in the USA by tumour size. The authors compared prescreening results (1975–1979) with postscreening (2008–2012 for size distribution, 2000–2002 for 10-year case death). They used a similar approach to Duffy et al 2 positing that reductions in … [1]: {openurl}?query=rft.jtitle%253DN%2BEngl%2BJ%2BMed%26rft.volume%253D375%26rft.spage%253D1438%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMoa1600249%26rft_id%253Dinfo%253Apmid%252F27732805%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1056/NEJMoa1600249&link_type=DOI [3]: /lookup/external-ref?access_num=27732805&link_type=MED&atom=%2Febmed%2F22%2F2%2F76.atom
Commentary on : Gupta A and ASCOT investigators. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase. Lancet 2017;389:2473–81. Several studies suggest that the low adherence rates with statin therapy are related to adverse events, particularly statin-associated muscle symptoms (SAMS).1 Rates of SAMS are found to be much higher in observational studies (10%–20%) compared with randomised controlled trials (RCTs) (1%–3%), which often find little difference in adverse events between statin and placebo groups.2 3 This study, having both blinded and unblinded phases, offers a unique perspective in looking at adverse events with statin therapy. The first trial phase was a randomised, blinded phase that included 10 180 patients aged 40–79 years with …
Commentary on: Knudsen AB, Zauber AG, Rutter CM, et al. Estimation of Benefits, Burden, and Harms of Colorectal Cancer Screening Strategies: Modeling Study for the US Preventive Services Task Force. JAMA 2016;315(23):2595–609.[OpenUrl][1][CrossRef][2][PubMed][3] Of the available colorectal cancer (CRC) screening tests, only flexible sigmoidoscopy and faecal occult blood tests have been evaluated with randomized controlled trials (RCTs). Colonoscopy and faecal immunochemical tests (FITs) are commonly used for CRC screening, but RCT evidence will not be available for at least a decade. For its 2016 CRC screening recommendation, the US Preventive Services Task Force (USPSTF) commissioned the Cancer Intervention and Surveillance Modeling Network (CISNET) to analyse 8 screening tests, in 204 screening strategies in a hypothetical cohort of US 40-year-olds, using 3 different models. Each model simulated the adenoma–carcinoma sequence with … [1]: {openurl}?query=rft.jtitle%253DJAMA%26rft.volume%253D315%26rft.spage%253D2595%26rft_id%253Dinfo%253Adoi%252F10.1001%252Fjama.2016.6828%26rft_id%253Dinfo%253Apmid%252F27305518%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1001/jama.2016.6828&link_type=DOI [3]: /lookup/external-ref?access_num=27305518&link_type=MED&atom=%2Febmed%2F22%2F2%2F59.atom
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.[OpenUrl][1] 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. 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, … [1]: {openurl}?query=rft.jtitle%253DJAMA%26rft.volume%253D316%26rft.spage%253D1455%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx
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. 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. 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 …
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. 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. This was …
We are changing the way the journal looks, feels and operates. In order to do this well, we would very much like your help in delivering relevant, trustworthy and impactful evidence-based content to as wide a range of frontline health professionals as possible. We are planning to publish original evidence-based research, insights and opinions on what matters …
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.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 This study examined the incidence of cardiorenal events in ACEI/ARB …
To survey ophthalmologists regarding sources they trust when incorporating new medical knowledge into their practice. The survey was distributed primarily to US-based ophthalmologists. Questions were derived based on the lead author's research experience from congresses and discussions and from mentions in the medical literature. In total, 77 physicians completed the survey of 1886 sent (4% response rate). Regarding study design, physicians preferred a well-controlled, randomised, double-masked trial (99%) with multicentred investigational site across a wide geographical area (80%). Authorship of a research article was most desired from a well-known key opinion leader (KOL) (75%) or any KOL leader at a university (75%). The most selected journal type was a subspecialty publication (86%) and second a multispecialty high impact journal (77%). Study sponsorship was most desired from the NIH or other government agencies (71%) or a university (71%). Doctors preferred clinical opinions from an ophthalmic medical society (75%). For the source of new clinical data, physicians indicated an unsponsored peer-reviewed journal article (77%) or a lecture at a large ophthalmic congress (74%) as the preferred source. Ophthalmologists generally desire sponsors, study designs and opinions that appear free of bias on which to base their clinical practice decisions.
Commentary on: Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. NEJM 2016;375:1834–44.[OpenUrl][1] Semaglutide is a glucagon-like peptide 1 (GLP-1) analogue under development for the treatment of type 2 diabetes. It is molecularly related to liraglutide but has a longer half-life, requiring once weekly dosing. US Food and Drug Administration (FDA) regulatory guidance requires evidence that new therapies for type 2 diabetes are not associated with an unacceptable increase in cardiovascular risk.1 ,2 This is defined as evidence that compared with placebo the risk ratio estimate has an upper 95% CI of 1.3; the initial preapproval phase may target the 1.8 margin; however, if 1.3 is not achieved then a postmarketing randomised safety trial is required.1 ,2 This was an industry-sponsored, non-inferiority randomised controlled trial in 3297 patients from 230 sites randomised (1:1:1:1), stratified (cardiovascular disease status, insulin treatment, and glomerular filtration rate at screening), to receive semaglutide (either 0.5 or 1.0 mg subcutaneously, weekly) or placebo. In … [1]: {openurl}?query=rft.jtitle%253DNEJM%26rft.volume%253D375%26rft.spage%253D1834%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx
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. 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 …
Evidence-Based Medicine (EBM) published by BMJ aims to alert clinicians to significant advances in healthcare by selecting original and systematic review articles, from 100 candidate journals, whose results are likely to be both reliable and useful.1 We select articles if they concern topics relevant to internal medicine, general and family practice, surgery, emergency and critical care, psychiatry, paediatrics or obstetrics and gynaecology. Articles are summarised in value-added abstracts and commented on by clinical experts in the field. To better understand the impact our choices may have on clinical practice, we audited 1 year’s worth of the journal’s commentaries, asking what journals we select from, what types of studies we choose and whether we identify articles likely to change practice. To do this, we surveyed EBM commentaries published between December 2016 and September 2017 and extracted the following information: study type, original journal, setting and type of intervention. We used the commentaries from clinical experts …
Journal clubs have many functions, including the provision of a forum for developing skills in critical appraisal, an essential part of being a competent clinician. From early on, journal clubs reported their proceedings in academic journals. The Zoological Journal Club of Michigan , for example, regularly reported its activities in the journal Science (see figure 1). Table 1 lists a selection of other journals that publish journal club articles, showing the wide range of topics covered. Modern methods of conducting journal clubs include the use of online media to encourage interactive discussion,1 including blogs,2 twitter,3 and virtual journal clubs.4 Figure 1 The contents page of Science for Friday 7 December 1900, listing the proceedings of the Zoological Journal Club of the University of Michigan . View this table: Table 1 Some journals that publish articles under the heading ‘Journal Club’ It is therefore appropriate that Evidence-Based Medicine (EBM) should feature a regular journal club report. In order to find out how others run journal clubs and the effects that they …
Commentary on: Ruospo M, Saglimbe VM, Palmer SC, et al . Glucose targets for preventing diabetic kidney disease and its progression. Cochrane Database Syst Rev 2017;6:CD010137. Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD). Randomised controlled trials (RCTs) suggest that intensive glycaemic control reduces progression of albuminuria, but effects on later DKD stages and cardiovascular outcomes are less clear. This systematic review evaluated the benefits and harms of intensive versus standard glycaemic control on the onset and progression of DKD and mortality. This meta-analysis of published tabular data included RCTs assigning patients with diabetes (type 1 or 2) with and without kidney disease to intensive (glycated haemoglobin (HbA1c) <7% or fasting blood glucose (FBG) <6.6 mmol/L) or standard glycaemic control (HbA1c ≥7% or FBG ≥6.6 mmol/L). Primary outcomes were doubling of serum creatinine, ESKD, and death or non-fatal myocardial infarction or stroke. Secondary outcomes included measures of albuminuria, serum creatinine, measures of glomerular …
