Showing papers in "Evidence-based Medicine in 2016"

New evidence pyramid

Abstract: A pyramid has expressed the idea of hierarchy of medical evidence for so long, that not all evidence is the same. Systematic reviews and meta-analyses have been placed at the top of this pyramid for several good reasons. However, there are several counterarguments to this placement. We suggest another way of looking at the evidence-based medicine pyramid and explain how systematic reviews and meta-analyses are tools for consuming evidence—that is, appraising, synthesising and applying evidence.

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

Abstract: Background The comparative effectiveness of non-pharmacological treatments of depression remains unclear. Methods We conducted an overview of systematic reviews to identify randomised controlled trials (RCTs) that compared the efficacy and adverse effects of non-pharmacological treatments of depression. We searched multiple electronic databases through February 2016 without language restrictions. Pairs of reviewers determined eligibility, extracted data and assessed risk of bias. Meta-analyses were conducted when appropriate. Result We included 367 RCTs enrolling ∼20 000 patients treated with 11 treatments leading to 17 unique head-to-head comparisons. Cognitive behavioural therapy, naturopathic therapy, biological interventions and physical activity interventions reduced depression severity as measured using standardised scales. However, the relative efficacy among these non-pharmacological interventions was lacking. The effect of these interventions on clinical response and remission was unclear. Adverse events were lower than antidepressants. Limitation The quality of evidence was low to moderate due to inconsistency and unclear or high risk of bias, limiting our confidence in findings. Conclusions Non-pharmacological therapies of depression reduce depression symptoms and should be considered along with antidepressant therapy for the treatment of mild-to-severe depression. A shared decision-making approach is needed to choose between non-pharmacological therapies based on values, preferences, clinical and social context.

EBHC pyramid 5.0 for accessing preappraised evidence and guidance.

Abstract: The 6S pyramid has provided a conceptual framework for searching information resources for evidence-based healthcare (EBHC) and is used in medical education and clinical informatics applications. This model has evolved into EBHC pyramid 5.0 which adds systematically derived recommendations as a major type of information and simplifies the overall framework to five major layers of information types.

Lumacaftor-ivacaftor (Orkambi) for cystic fibrosis: behind the ‘breakthrough’

Abstract: Lumacaftor-ivacaftor (Orkambi) was recently approved by the Food and Drug Administration (FDA) in the USA to treat patients at least 12 years old who have cystic fibrosis due to two copies of the F508del ( Phe508del ) mutation in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene. Lumacaftor-ivacaftor has been designated a ‘breakthrough’ and is slated to cost $259 000 per year per patient, but close scrutiny of the data behind this new medication reveals modest improvements in outcomes that are not exclusively benefited by lumacaftor-ivacaftor, and the $259 000 cost is questionable and problematic. Providers considering this therapy should have a candid and easily-understandable discussion with their patients about what the data show for lumacaftor-ivacaftor so their patients can make an informed decision about taking it. This article aims to help this process.

Pyramids are guides not rules: the evolution of the evidence pyramid

Abstract: Soon after the inception of the evidence-based medicine (EBM) movement in the 1990s, the evidence pyramid rose from the sand.1 As more evidence resources and resources for finding evidence were developed it became necessary to provide guidance on their use. The original ‘4S’ system (systems (eg, computerised decision support), synopses, syntheses, studies) soon evolved into the ‘5S’ system by adding summaries (‘evidence-based textbooks’), which incorporated information from the lower levels of the pyramid into a more comprehensive evidence base for managing a given condition.2 The latest evolution of this model by Haynes and colleagues, the ‘6S’ model, recognised that not all synopses (succinct, structured summaries of clinically important, methodologically sound studies published in evidence-based journal like this one) are equal, and synopses were further divided into two levels (synopses of studies and synopses of syntheses).3 A further complexity of these pyramids is a hierarchy or pyramid of individual studies, which are located at the base of the ‘4S’ through ‘6S’ pyramids. This pyramid within a pyramid begins with in vitro studies at its base followed by ideas and opinions, case reports and case series, case–control studies, cohort studies, randomised controlled trials (RCT), and culminating with systematic reviews/meta-analysis at its apex.4 Inherent in all of these pyramids is the concept (while not always true) of a hierarchy; that less valid (higher risk of bias) evidence is at the bottom of the pyramid and more valid at the top. Also …

Formative assessment and design of a complex clinical decision support tool for pulmonary embolism.

Abstract: Electronic health record (EHR)-based clinical decision support (CDS) tools are rolled out with the urgency to meet federal requirements without time for usability testing and refinement of the user interface. As part of a larger project to design, develop and integrate a pulmonary embolism CDS tool for emergency physicians, we conducted a formative assessment to determine providers' level of interest and input on designs and content. This was a study to conduct a formative assessment of emergency medicine (EM) physicians that included focus groups and key informant interviews. The focus of this study was twofold, to determine the general attitude towards CDS tool integration and the ideal integration point into the clinical workflow. To accomplish this, we first approached EM physicians in a focus group, then, during key informant interviews, we presented workflow designs and gave a scenario to help the providers visualise how the CDS tool works. Participants were asked questions regarding the trigger location, trigger words, integration into their workflow, perceived utility and heuristic of the tool. Results from the participants' survey responses to trigger location, perceived utility and efficiency, indicated that the providers felt the tool would be more of a hindrance than an aid. However, some providers commented that they had not had exposure to CDS tools but had used online calculators, and thought the tools would be helpful at the point-of-care if integrated into the EHR. Furthermore, there was a preference for an order entry wireframe. This study highlights several factors to consider when designing CDS tools: (1) formative assessment of EHR functionality and clinical environment workflow, (2) focus groups and key informative interviews to incorporate providers' perceptions of CDS and workflow integration and/or (3) the demonstration of proposed workflows through wireframes to help providers visualise design concepts.

Are eponyms used correctly or not? A literature review with a focus on shoulder and elbow surgery.

Abstract: Background Eponymous terms are used frequently in daily patient care and scientific literature. They remind us of our predecessors in surgery. It is debatable whether eponymous terms are reliable in case of information transfer. The aim of our study was to investigate whether the original meaning of eponymous terms in shoulder and elbow surgery has been preserved in its use in contemporary literature. Objective To evaluate whether eponymous terms were used correctly, we analysed the use of frequently encountered eponymous terms from January to December 2014. Study selection By means of a PubMed search, articles with eponymous terms were identified and analysed for the way an eponymous term was used, and we compared it with the original description. The original description was traced back to the index publication. The use of the eponymous term was scored as similar, divergent or undefined. In the search for eponymous terms, we included those eponymous terms that were used more than 10 times in the English, German and Dutch literature of 2014. 6 eponymous terms were eligible for analysis: Bankart lesion, Bristow-Latarjet procedure, Essex-Lopresti injury of the forearm, Galeazzi fracture, Hill-Sachs lesion and Monteggia fracture. Findings We analysed 96 articles with the listed eponymous terms, of which 27 (28%) were scored divergent, 32 (33%) undefined and 37 (39%) similar. Bristow-Latarjet scored lowest, with 0% descriptions similar to the original, meaning that all articles had an undefined or divergent eponym, and Essex-Lopresti scored highest with 82% similarity. Conclusions Eponymous terms in shoulder and elbow trauma and surgery are used inadequately and inconsistently. The use of eponymous terms probably cannot be avoided, but since the majority of eponymous terms are not used properly and understanding of its meaning and content varies from surgeon to surgeon, we should be keen on explaining the meaning of eponymous terms when using them.

‘Spin’ in reports of clinical research

Abstract: © 2016 Published by the BMJ Publishing Group Limited. Clinical research is frequently hampered by flaws in its design or conduct. Such biases have been well documented. However, reports of clinical research may also be biased and present results in a more favourable way than they deserve or downplay harms. Such 'spin' in reporting has been demonstrated empirically. This short commentary summarises some of the problems with spin in reports of clinical research as well as signposts to some of the empirical evidence demonstrating its effect.

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

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

Mediterranean diet supplemented with extra virgin olive oil reduces the incidence of invasive breast cancer in a randomised controlled trial

Abstract: Commentary on: Toledo E, Salas-Salvado J, Donat-Vargas C, et al. Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED trial: a randomized clinical trial. JAMA Intern Med 2015;175:1752–60.[OpenUrl][1][CrossRef][2][PubMed][3] A Mediterranean dietary (MedD) pattern has been associated with a number of beneficial effects. Thus, recent meta-analyses could show an inverse association between high adherence to a MedD pattern and overall cancer mortality, as well as incidence of various types of cancer.1–3 However, these associations have been exclusively based on the synthesis of results derived from observational studies. The PREDIMED study was a Spanish multicentre randomised single blind controlled trial including 7447 participants at high risk of, but without manifested cardiovascular diseases. The subanalysis presented by Toledo and co-workers included 4282 postmenopausal women (4152 without previous history of breast cancer) who had been allocated into two dietary … [1]: {openurl}?query=rft.jtitle%253DJAMA%2BIntern%2BMed%26rft.volume%253D175%26rft.spage%253D1752%26rft_id%253Dinfo%253Adoi%252F10.1001%252Fjamainternmed.2015.4838%26rft_id%253Dinfo%253Apmid%252F26365989%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/jamainternmed.2015.4838&link_type=DOI [3]: /lookup/external-ref?access_num=26365989&link_type=MED&atom=%2Febmed%2F21%2F2%2F72.atom

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

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

Prophylactic tranexamic acid in addition to uterotonics may prevent blood loss for vaginal and caesarean deliveries

Abstract: Commentary on: Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev 2015;6:CD007872 Postpartum haemorrhage (PPH) as defined by blood loss >500 mL occurs in 3–15% of deliveries, leads to a life-threatening event in one out of five cases, and is responsible for about 25% of all maternal deaths worldwide.1 During delivery, a sequence of physiological and haemostatic changes occurs that reduces bleeding, in particular strong myometrial contractions, and increase in the fibrinolytic activity.2 To date, only the use of uterotonics has been shown to be effective in preventing PPH and is widely recommended by all authorities after vaginal or caesarean deliveries.1 Tranexamic acid (TXA), an antifibrinolytic agent, reduces transfusion in elective surgical patients, mortality in bleeding trauma patients, and menstrual blood loss in women with menorrhagia. …

Aerobic exercise training reduces bronchial hyper-responsiveness and serum pro-inflammatory cytokines in patients with asthma.

Abstract: Commentary on: Franca-Pinto A, Mendes FAR, de Carvalho-Pinto RM, et al. Aerobic training decreases bronchial hyper-responsiveness and systemic inflammation in patients with moderate or severe asthma: a randomised controlled trial. Thorax 2015;70:732–9.[OpenUrl][1][Abstract/FREE Full Text][2] Exercise is a well-known trigger for asthma symptoms. In patients with asthma, strenuous physical activity increases the risk of an asthma attack, with a ‘U’-shaped curve showing that moderate exercise training carries a lower risk of asthma compared to high-intensity exercise training. Lack of physical activity appears to be independently associated with increased bronchial hyper-responsiveness (BHR).1 These observations are confirmed by a growing number of murine studies, but reviews examining the epidemiological evidence for such associations in humans show that the overall evidence on exercise and asthma is, at best, very … [1]: {openurl}?query=rft.jtitle%253DThorax%26rft_id%253Dinfo%253Adoi%252F10.1136%252Fthoraxjnl-2014-206070%26rft_id%253Dinfo%253Apmid%252F26063507%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/ijlink?linkType=ABST&journalCode=thoraxjnl&resid=70/8/732&atom=%2Febmed%2F21%2F2%2F70.atom

Early exposure to dogs and farm animals reduces risk of childhood asthma

Abstract: Commentary on: Fall T, Lundholm C, Ortqvist AK, et al. Early Exposure to Dogs and Farm Animals and the Risk of Childhood Asthma. JAMA Pediatr 2015;169:e153219. Asthma is one of the most common chronic diseases of childhood. The risk of developing asthma is associated with environmental exposures, including tobacco smoke, air pollution, dust mites, endotoxin and farm animals.1 A lower prevalence of asthma among children in farm environments supports the hygiene hypothesis on the role of childhood exposure to microbes in developing a more favourable immune system. The effect of exposures to domestic dogs has been less clear. Fall et al undertook a nationwide study to investigate the association between early exposures to dogs as well as farm environment and risk of childhood …

Natural language processing: use in EBM and a guide for appraisal

Abstract: Studies using natural language processing (NLP) techniques are increasingly being published. Evidence-based medicine (EBM) users need to learn the basics of NLP to be able to appraise these types of studies. We propose a set of criteria to evaluate the quality of studies that have used NLP, focusing on the methods of sample selection, coding, the gold standard, algorithm training, algorithm testing and measures of accuracy (such as recall and precision). NLP has proven critical for conducting biomedical research and has the potential to improve healthcare practice and facilitate EBM. Stakeholders (healthcare providers and policymakers) interested in using evidence derived from studies that used NLP need to know the basics of NLP and need to be able to appraise this type of study.

Importance and methods of searching for E-publications ahead of print in systematic reviews

Abstract: In an attempt to keep pace with the increasing number of trials being conducted each year, journals make articles available as E-publications ahead of print. E-publications are not available to search through the conventional databases (MEDLINE, EMBASE, CENTRAL) used in systematic reviews, but are searchable using PubMed. We used a search syntax designed to exclusively identify E-publications in PubMed to assess the importance of searching for E-publications in systematic reviews. Two case studies were conducted: updating de novo systematic reviews in particularly active areas of current research, type 2 diabetes mellitus and advanced melanoma. A search for E-publications was conducted concurrently to the conventional systematic reviews. Network diagrams were constructed with and without the results of the E-publications search to demonstrate the potential impact E-publications could have on any evidence synthesis. The advanced melanoma systematic review conducted in conventional databases identified nine studies. The E-publication search identified three additional studies reporting information for three new interventions and additional information for five interventions. Critically, if an evidence synthesis were to be conducted the identification of one of the pivotal nivolumab trials, CheckMate 067, (ipilimumab, nivolumab and ipilimumab+nivolumab) allows the connection of an otherwise disconnected evidence network. The diabetes systematic review conducted in conventional databases identified 28 studies. The E-publication search identified one additional study including an extra intervention; if evidence synthesis were feasible, the E-publication would add a loop to the evidence network which could influence analysis results. Failure to search for E-publications ahead of print may mean that evidence syntheses do not take into account all the data publicly available at the time of review.

‘Cognitive biases plus’: covert subverters of healthcare evidence

Abstract: The evidence-based medicine (EBM) paradigm has been associated with many benefits, but there have also been ‘some negative consequences’. In part, the consequences may be attributable to: (1) limitations in some of the tenets of EBM, and (2) flawed or unethical decisions in healthcare related organisations. We hypothesise that at the core of both is a cascade of predominantly unconscious cognitive processes we have syndromically termed ‘cognitive biases plus’, with conflicts of interest (CoIs) as crucial elements. CoIs (financial, and non-financial including intellectual) catalyse self-serving bias and a cascade of other ‘cognitive biases plus’ with several reinforcing loops. Authority bias, herd effect, scientific inbreeding, replication publication biases, and ethical violations (especially subtle statistical), are key contributors to the cascade; automation biases through uncritical use of statistical software and applications (apps) of preappraised sources of evidence at point of care, may be other increasingly important factors. The ‘cognitive biases plus’ cascade which involves several intricately connected healthcare-related organisations has the potential to facilitate, compound and entrench flaws in the paradigm, evidence and decisions that converge to inform person-centered healthcare. Our reasoning is based on observational data and opinion. However, the susceptibility of all humans to ‘cognitive biases plus’ makes our hypothesis plausible. Individual and collective fallibility may be minimised and the quality of healthcare decisions (including those related to improving EBM) enhanced by being conscious of our vulnerability and open-minded to the ‘outside view’.

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

Abstract: Commentary on: Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med 2016;374:2222–34[OpenUrl][1][CrossRef][2][PubMed][3]. A substantial body of evidence shows that inhaled corticosteroids (ICSs) reduce the risk of exacerbations by 10–20% beyond that achieved by inhaled long-acting β2-adrenergic agonist (LABA) and also reduce progression of lung function loss, improving health-related quality of life.1 However, drawbacks of ICSs in chronic obstructive pulmonary disease (COPD) (increased risk of pneumonia, osteoporosis, hyperglycaemia in patients with diabetes, cataracts, skin bruising and glaucoma) are the reason why all COPD guidelines recommend ICSs only for patients with severe impairment and high risk of exacerbations.1 Nonetheless, ICSs are still overprescribed worldwide.2 A randomised, double-blind, double dummy, non-inferiority trial lasting 52 weeks enrolled 3362 patients suffering from COPD with … [1]: {openurl}?query=rft.jtitle%253DN%2BEngl%2BJ%2BMed%26rft.volume%253D374%26rft.spage%253D2222%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMoa1516385%26rft_id%253Dinfo%253Apmid%252F27181606%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/NEJMoa1516385&link_type=DOI [3]: /lookup/external-ref?access_num=27181606&link_type=MED&atom=%2Febmed%2F21%2F6%2F222.atom

Evidence-based medicine and life-long learning competency requirements in new residency teaching standards

Abstract: The objective of this study is to compare accreditation standards across medical and surgical specialties in the USA to determine the requirements for evidence-based medicine (EBM) and information management (life-long learning) skills education in residency training programmes in the USA. We performed a descriptive analysis of ‘milestones’ statements that form the basis for oversight of residency training of the Next Accreditation System for the 28 major specialties and the transition year residency, searching the milestone statements for competency requirements for 15 EBM or information management topics. The search was performed independently by pairs of researchers, with a third researcher independently verifying their findings. No specialty requires all 15 topics. Basic EBM knowledge is required by fewer than half of all specialties. Only 14% of milestone statements specify the ability to identify bias in clinical research trials. Most specialties (79%) require demonstration of the use of evidence in practice. MEDLINE searching capability is required by 52% of specialties; competence in using secondary sources is required by 69%. There is little emphasis (22%) on evaluation of these information sources. Evaluation of information from experts, colleagues or pharmaceutical representatives is required by only 38%. Competence in developing methods of keeping up with new evidence is specified by only four specialties (14%). The results signal a shift in teaching requirements during residency training, away from classic evidence-based and towards information management skills. However, requirements are limited to published materials and rarely extend to information from human sources.

Increasing children's time spent outdoors reduces the incidence of myopia

Abstract: Commentary on: He M, Xiang F, Zeng Y, et al. Effect of time spent outdoors at school on the development of myopia among children in China: a randomized clinical trial. JAMA 2015;314:1142–8.[OpenUrl][1][CrossRef][2][PubMed][3] The epidemic of myopia has been well-documented in urban East Asia, exceeding 80% in school leavers, with evidence suggesting moderate rises elsewhere.1 Given the strong link between myopia and sight-threatening pathology,1 curbing myopia has become a major topic of public health interest. This has sparked research to identity modifiable factors, with increased time outdoors consistently shown to prevent myopia.2 This randomised control trial is the largest to investigate the efficacy of increasing the time children spend outdoors in the prevention of myopia. Primary schools (n=30) in Guangzhou, China were divided into six strata according to uncorrected visual acuity (VA), … [1]: {openurl}?query=rft.jtitle%253DJAMA%26rft.volume%253D314%26rft.issue%253D11%26rft.spage%253D1142%26rft.atitle%253DEFFECT%2BOF%2BTIME%2BSPENT%2BOUTDOORS%2BAT%2BSCHOOL%2BON%2BTHE%2BDEVELOPMENT%2BOF%2BMYOPIA%2BAMONG%2BCHILDREN%2BIN%2BCHINA%253A%2BA%2BRANDOMIZED%2BCLINICAL%2BTRIAL%26rft_id%253Dinfo%253Adoi%252F10.1001%252Fjama.2015.10803%26rft_id%253Dinfo%253Apmid%252F26372583%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.2015.10803&link_type=DOI [3]: /lookup/external-ref?access_num=26372583&link_type=MED&atom=%2Febmed%2F21%2F2%2F76.atom

Large ovarian cancer screening trial shows modest mortality reduction, but does not justify population-based ovarian cancer screening

Abstract: Commentary on : Jacobs IJ, Menon U, Ryan A, et al. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet 2015;387:945–56.[OpenUrl][1][PubMed][2] Ovarian cancer is the most fatal gynaecological malignancy. Most cancers are detected at advanced stages when therapeutic options are limited. Epithelial ovarian cancers are heterogeneous with respect to cell of origin, molecular pathways, morphological appearance, risk factor associations and survival.1 ,2 High-grade serous carcinomas are most common and have the worst prognosis. Currently, proposed ovarian cancer screening strategies include transvaginal ultrasound and CA-125 blood testing. In a previous randomised controlled trial evaluating these strategies, no mortality benefit was observed.3 In the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), around 200 000 women aged 50–74 were enrolled and randomly assigned to … [1]: {openurl}?query=rft.jtitle%253DLancet%26rft.volume%253D387%26rft.spage%253D945%26rft_id%253Dinfo%253Apmid%252F26707054%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=26707054&link_type=MED&atom=%2Febmed%2F21%2F4%2F159.atom

Structured diet and physical activity programmes provide strong evidence of effectiveness for type 2 diabetes prevention and improvement of cardiometabolic health

Abstract: Commentary on : Balk EM, Earley A, Raman G, et al. Combined diet and physical activity promotion programs to prevent type 2 diabetes among persons at increased risk: a systematic review for the community preventive services task force. Ann Intern Med 2015;163:437–51.[OpenUrl][1][CrossRef][2][PubMed][3] Type 2 diabetes mellitus (T2DM) is a significant and growing medical problem affecting close to 400 million people worldwide1 and almost 10% of the US population2 while imposing a major financial burden on society.3 Furthermore, an estimated 37% of the US adult population is at risk of T2DM, making primary prevention of T2DM a critical public health objective. Large clinical trials have shown that combined diet and physical activity promotion programmes … [1]: {openurl}?query=rft.jtitle%253DAnn%2BIntern%2BMed%26rft.volume%253D163%26rft.spage%253D437%26rft_id%253Dinfo%253Adoi%252F10.7326%252FM15-0452%26rft_id%253Dinfo%253Apmid%252F26167912%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=10.7326/M15-0452&link_type=DOI [3]: /lookup/external-ref?access_num=26167912&link_type=MED&atom=%2Febmed%2F21%2F1%2F18.atom

Ultrasound-based IOTA simple rules allow accurate malignancy risk estimation for adnexal masses

Abstract: Commentary on : Timmerman D, Van Calster B, Testa A, et al. Predicting the risk of malignancy in adnexal masses based on the simple rules from the international ovarian tumor analysis group. Am J Obstet Gynecol 2016;214:424–37. Adnexal masses are a common clinical problem, with ovarian cancer remaining as the most lethal gynaecological malignancy. Evidence shows that women with ovarian cancer should be primarily treated at specialised centres,1 while women with benign adnexal masses can be treated by general gynaecologists.2 Accurate diagnosis is essential for adequate triage. Currently, the best method for discriminating benign from malignant adnexal masses is ultrasound assessment by an expert examiner.3 The international ovarian tumour analysis (IOTA) group has proposed a simple risk estimation approach based on ultrasound features of the ovarian tumours (five benign and five malignant), the so-called …

Fusion in degenerative spondylolisthesis becomes controversial…again

Abstract: Commentary on : Forsth P, Olafsson G, Carlsson T, et al. A Randomized, controlled trial of fusion surgery for lumbar spinal stenosis. N Engl J Med 2016;374:1413–23[OpenUrl][1][CrossRef][2][PubMed][3]. Ghogawala Z, Dziura J, Butler WE, et al. Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis. N Engl J Med 2016;374:1424–34.[OpenUrl][4][CrossRef][5][PubMed][6] The role of fusion in degenerative spondylolisthesis (DS) was hotly debated in the 1990s, until two studies were performed suggesting that patients undergoing fusion in addition to laminectomy had better outcomes and less progression of listhesis than patients undergoing laminectomy alone.1 ,2 These were single centre studies that used rudimentary randomisation techniques and generally subjective, surgeon-reported outcomes. While relatively high-quality studies for the time, they would be viewed as no better than level 2 evidence today. Based largely on the results of these studies and the explosion of new devices, laminectomy and fusion became the standard treatment for DS, and over 95% of patients with DS undergoing surgery in the USA now undergo a fusion with some type of instrumentation.3 More recently, the role of fusion has been questioned, especially as less invasive decompressive techniques have been developed.4 As a result, two recent randomised controlled trials were performed comparing laminectomy to laminectomy and fusion. Forsth et al 5 reported the results of the Swedish Spinal Stenosis Study (SSSS), which included 247 patients, 135 of whom had DS. The trial was performed at seven sites across Sweden, with patient enrolment from 2006 to 2012. They randomised patients to either decompression alone (D) or decompression and fusion (DF). All patients with DS underwent a midline laminectomy, and … [1]: {openurl}?query=rft.jtitle%253DN%2BEngl%2BJ%2BMed%26rft.volume%253D374%26rft.spage%253D1413%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMoa1513721%26rft_id%253Dinfo%253Apmid%252F27074066%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/NEJMoa1513721&link_type=DOI [3]: /lookup/external-ref?access_num=27074066&link_type=MED&atom=%2Febmed%2F21%2F4%2F148.atom [4]: {openurl}?query=rft.jtitle%253DN%2BEngl%2BJ%2BMed%26rft.volume%253D374%26rft.spage%253D1424%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMoa1508788%26rft_id%253Dinfo%253Apmid%252F27074067%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 [5]: /lookup/external-ref?access_num=10.1056/NEJMoa1508788&link_type=DOI [6]: /lookup/external-ref?access_num=27074067&link_type=MED&atom=%2Febmed%2F21%2F4%2F148.atom

Physicians frequently fail to de-intensify treatment in older patients with diabetes and very low haemoglobin A1c or blood pressure

Abstract: Commentary on : Sussman JB, Kerr EA, Saini SD, et al. Rates of Deintensification of Blood Pressure and Glycemic Medication Treatment Based on Levels of Control and Life Expectancy in Older Patients With Diabetes Mellitus. JAMA Intern Med 2015;175:1942–9[OpenUrl][1][CrossRef][2][PubMed][3]. The goals of diabetes care are to ensure maximal treatment benefit, with the least harm and treatment burden, based on each patient's individual circumstances. Thus, glycemic and blood pressure targets need to be individualised in the context of patient's age, life expectancy and burden of comorbidities. However, in clinical practice, many older patients with diabetes achieve unnecessarily low levels of glucose and blood pressure (BP) control—levels that are unlikely to provide benefit and may actually lead to harm, such as hypoglycaemia, hypotension, falls and medication side effects.1 ,2 Prior studies have not examined whether treatment is de-intensified as part of routine diabetes care when glycemic or BP levels … [1]: {openurl}?query=rft.jtitle%253DJAMA%2BIntern%2BMed%26rft.volume%253D175%26rft.spage%253D1942%26rft_id%253Dinfo%253Adoi%252F10.1001%252Fjamainternmed.2015.5110%26rft_id%253Dinfo%253Apmid%252F26502220%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/jamainternmed.2015.5110&link_type=DOI [3]: /lookup/external-ref?access_num=26502220&link_type=MED&atom=%2Febmed%2F21%2F4%2F158.atom

Study raises new doubts regarding the hypothesised health benefits of 'moderate' alcohol use.

Abstract: Commentary on : Goulden R. Moderate alcohol consumption is not associated with reduced all-cause mortality. Am J Med 2016;129:180–6.e4.[OpenUrl][1][CrossRef][2][PubMed][3] Many observational studies find associations between ‘moderate’ alcohol use and reduced mortality risk compared with abstention. Low doses of alcohol have also been associated with improvements in some biomarkers of cardiovascular health in short-term randomised studies. However, the absence of any randomised clinical trial of any morbidity or mortality outcome, and contradictory Mendelian randomisation studies,1 cast doubt on the veracity of associations found in observational studies. Goulden lists alternative explanations for the classic J-shaped curve for alcohol use and mortality risk, including selection bias, misclassification of drinkers as abstainers and residual confounding. We comment here as authors of a meta-analysis2 raising identical concerns and reporting similar findings. Goulden examined the relationship between level of average daily alcohol consumption and risk of death … [1]: {openurl}?query=rft.jtitle%253DAm%2BJ%2BMed%26rft.volume%253D129%26rft.spage%253D180%26rft_id%253Dinfo%253Adoi%252F10.1016%252Fj.amjmed.2015.10.013%26rft_id%253Dinfo%253Apmid%252F26524703%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=10.1016/j.amjmed.2015.10.013&link_type=DOI [3]: /lookup/external-ref?access_num=26524703&link_type=MED&atom=%2Febmed%2F21%2F4%2F156.atom

Restarting oral anticoagulation among patients with atrial fibrillation with gastrointestinal bleeding was associated with lower risk of all-cause mortality and thromboembolism

Abstract: Commentary on : Staerk L, Lip GY, Olesen JB, et al. Stroke and recurrent haemorrhage associated with antithrombotic treatment after gastrointestinal bleeding in patients with atrial fibrillation: nationwide cohort study. BMJ 2015;351:h5876.[OpenUrl][1][Abstract/FREE Full Text][2] Atrial fibrillation (AF) is associated with higher risk of thromboembolism and thus warrants the use of anticoagulants for prevention of adverse outcomes.1 However, anticoagulation comes at the price of a higher risk of gastrointestinal bleeding (GIB). Current guidelines recommend interrupting anticoagulation in the case of GIB but do not inform on whether it should be resumed. This study assesses risks of all-cause mortality, thromboembolism, major bleeding and recurrent GIB associated with resuming antithrombotic treatment after GIB among patients with AF. This prospective cohort study included non-valvular patients with AF who experienced GIB while receiving single or combined antithrombotic treatment with an antiplatelet and/or anticoagulant in a Danish cohort … [1]: {openurl}?query=rft.jtitle%253DBMJ%26rft_id%253Dinfo%253Adoi%252F10.1136%252Fbmj.h5876%26rft_id%253Dinfo%253Apmid%252F26572685%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/ijlink?linkType=ABST&journalCode=bmj&resid=351/nov16_2/h5876&atom=%2Febmed%2F21%2F4%2F152.atom

Nebulised hypertonic saline may be less effective than previously reported in reducing hospital length of stay and admission rate in acute bronchiolitis

Abstract: Commentary on : Zhang L, Mendoza-Sassi RA, Klassen TP, et al. Nebulized hypertonic saline for acute bronchiolitis: a systematic review. Pediatrics 2015;136:687–701.[OpenUrl][1][Abstract/FREE Full Text][2] Acute bronchiolitis is the most common cause of hospitalisation of infants. There is no specific therapy that provides consistent benefit. Nebulised hypertonic saline (HS) may be theoretically effective by improving mucociliary clearance, and reducing airway oedema and mucus viscosity. HS has been investigated as a therapeutic intervention in multiple studies, with inconsistent results. A 2013 Cochrane meta-analysis concluded that HS is a safe and effective treatment for acute bronchiolitis.1 This analysis of 11 randomised controlled trials (RCTs) (1090 infants) found a 1.15 days (95% CI 0.82 to 1.49) shorter mean hospital length of stay (LOS) in those treated with HS compared with normal saline (NS). Although initially promising, subsequent RCTs have shown that HS may not be as effective as … [1]: {openurl}?query=rft.jtitle%253DPediatrics%26rft_id%253Dinfo%253Adoi%252F10.1542%252Fpeds.2015-1914%26rft_id%253Dinfo%253Apmid%252F26416925%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/ijlink?linkType=ABST&journalCode=pediatrics&resid=136/4/687&atom=%2Febmed%2F21%2F4%2F143.atom

Emergency department visits and hospitalisations for adverse events related to dietary supplements are common

Abstract: Commentary on: Geller AI, Shehab N, Weidle NJ, et al. Emergency department visits for adverse events related to dietary supplements. N Eng J Med 2015;373:1531–40.[OpenUrl][1][CrossRef][2][PubMed][3] Vitamins, minerals, probiotics, botanical extracts and other ingredients are sold as dietary supplements in the USA.1 Supplements are sold directly to consumers and do not require premarket approval. All supplements are presumed to be safe. However, prior research has found that individual supplements can pose serious health risks.2 ,3 This study was the first attempt to estimate the number of consumers in the USA who require emergency department (ED) visits or hospitalisations due to supplement adverse events. The authors estimated the number of ED visits and hospital admissions for adverse events associated with dietary supplements in … [1]: {openurl}?query=rft.jtitle%253DN%2BEng%2BJ%2BMed%26rft.volume%253D373%26rft.spage%253D1531%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMsa1504267%26rft_id%253Dinfo%253Apmid%252F26465986%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/NEJMsa1504267&link_type=DOI [3]: /lookup/external-ref?access_num=26465986&link_type=MED&atom=%2Febmed%2F21%2F2%2F79.atom

Improving reporting and utility of evaluations of complex interventions

Abstract: Global healthcare systems are buckling under the increasing burden of chronic disease and multimorbidity.1 Research into the efficacy of interventions to address chronic disease are needed. These potential solutions often include consideration of questions of complex, non-drug interventions such as processes of care, diet, exercise and behavioural interventions; areas with a deficit of study.2 Unfortunately, knowledge creation and dissemination is insufficient to affect behaviour, practice and policy change within diverse healthcare contexts.3 ,4 There is a need to study in situ—in multiple contexts—the impact of interventions. However, there have been concerns with the current reporting and quality of studies in these areas.2 ,5 In the design of studies on real-world interventions, researchers must move beyond unidirectional models of behaviour change and instead look to engaging evidence users, patients and clinicians, in: identifying questions and interventions of interest,6 and planning and executing the study to ensure that the implementation efforts are context appropriate.7–9 Co-creation in this way will increase the likelihood that the problems identified, and the solutions, resonate with the patients and clinicians; increasing the likelihood that there will be strong participant engagement and effort to implement and sustain the clinical change.8 ,9 From a researcher perspective there are significant challenges to undertaking work in this way. Non-medication interventions are of keen interest to patients and clinicians,6 but it is methodologically much easier to design a trial to evaluate a regulated intervention (medication, device and procedure), than it is to design and evaluate an assessment of non-regulated interventions (ie, service delivery, behavioural interventions, physical therapies).6 The significant up front engagement work of this approach is time consuming, challenging to achieve in research funding cycles, and high-risk because it requires contextual stability from real-world clinical care organisations to maintain …