Postmarketing studies: can they provide a safety net for COVID-19 vaccines in the UK?
In the current era of the COVID-19 pandemic, the world has never been more interested in the process of vaccine development. While researchers across the globe race to find an effective yet safe vaccine to protect populations from the newly emergent SARS-CoV-2 virus, more than one-third of the world has been subjected to either full or partial lockdown measures. With communities having felt the burden of prolonged isolation, finding a safe and efficacious vaccine will yield direct beneficial effects on protecting against COVID-19 morbidity and mortality and help relieve the psychological and economic load on communities li...
Source: Evidence-Based Medicine - January 19, 2022 Category: Internal Medicine Authors: Dhanda, S., Osborne, V., Lynn, E., Shakir, S. Tags: Open access, COVID-19 EBM analysis Source Type: research
Improving the transparency of meta-analyses with interactive web applications
Increased transparency in study design and analysis is one proposed solution to the perceived reproducibility crisis facing science. Systematic review and meta-analysis—through which individual studies on a specific association are ascertained, assessed for quality and quantitatively combined—is a critical process for building consensus in medical research. However, the conventional publication model creates static evidence summaries that force the quality assessment criteria and analytical choices of a small number of authors onto all stakeholders, some of whom will have different views on the quality assessme...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Ahern, T. P., MacLehose, R. F., Haines, L., Cronin-Fenton, D. P., Damkier, P., Collin, L. J., Lash, T. L. Tags: Open access, General Medicine Research methods and reporting Source Type: research
Conventional compared to network meta-analysis to evaluate antibiotic prophylaxis in patients with cancer and haematopoietic stem cell transplantation recipients
Our purpose was to compare conventional meta-analysis and network meta-analysis to evaluate the efficacy of different prophylactic systemic antibiotic classes in patients undergoing chemotherapy or haematopoietic stem cell transplant (HSCT). We included randomised trials if patients had cancer or were HSCT recipients and the intervention was systemic antibacterial prophylaxis. Three types of control groups were used: (1) placebo, no antibiotic and non-absorbable antibiotic separately; (2) placebo and no antibiotic combined; and (3) all three combined. These gave different network geometries. Strategies synthesised were flu...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Martinez, J. P. D., Robinson, P. D., Phillips, B., Lehrnbecher, T., Koenig, C., Fisher, B., Egan, G., Dupuis, L. L., Ammann, R. A., Alexander, S., Cabral, S., Tomlinson, G., Sung, L. Tags: General Medicine Research methods and reporting Source Type: research
Limited engagement with transparent and open science standards in the policies of pain journals: a cross-sectional evaluation
This study aimed to evaluate 10 highest ranked pain journals’ authorship policies with respect to their support for transparent and open research practices. Two independent authors evaluated the journal policies (as at 27 May 2019) using three tools: the self-developed Transparency and Openness Evaluation Tool, the Centre for Open Science (COS) Transparency Factor and the International Committee of Medical Journal Editors (ICMJE) requirements for disclosure of conflicts of interest. We found that the journal policies had an overall low level of engagement with research transparency and openness standards. The median ...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Cashin, A. G., Bagg, M. K., Richards, G. C., Toomey, E., McAuley, J. H., Lee, H. Tags: Research methods and reporting Source Type: research
Optimising the process for conducting scoping reviews
We present five recommendations based on our experience when conducting a particularly challenging scoping review: (1) engage the expertise of a librarian throughout the process, (2) conduct a truly systematic search, (3) facilitate communication and collaboration, (4) explore new tools or repurpose old ones, and (5) test every stage of the process. These recommendations add to the literature by providing specific and detailed advice on each stage of a scoping review. Our intent is for these recommendations to aid other teams that are undertaking knowledge synthesis projects. (Source: Evidence-Based Medicine)
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Pawliuk, C., Brown, H. L., Widger, K., Dewan, T., Hermansen, A.-M., Gregoire, M.-C., Steele, R., Siden, H. Tags: Evidence synthesis Source Type: research
Breast density notification: evidence on whether benefit outweighs harm is required to inform future screening practice
The current landscape of breast density notification Breast density is one of a number of independent risk factors for breast cancer.1 Having dense breasts (heterogeneously dense or extremely dense) is prevalent in 40%–50% of women in the breast screening population,2 making it one of the most common risk factors for breast cancer. Separate from this, having dense breasts also increases a woman’s risk of having a breast cancer missed on mammography, meaning that it increases the risk of having an interval cancer diagnosed before the next scheduled mammogram in screening participants.3 This is due to the lower s...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Nickel, B., Farber, R., Brennan, M., Hersch, J., McCaffery, K., Houssami, N. Tags: EBM opinion and debate Source Type: research
Is clinical effectiveness in the eye of the beholder during the COVID-19 pandemic?
There is no shortage of clichés being used during the current global pandemic, but none is more striking than the Hippocratic aphorism ‘for extreme diseases, extreme methods of cure’ or, in its modern variants, ‘for desperate times, desperate measures’ or even, ‘take it! What do you have to lose?’. The current crisis has challenged the erroneous perception that threats to global public health by rapidly spreading infectious diseases were under control. COVID-19 is indeed an extreme disease, not in its nature but due to its global reach and the level of social disruption it is caus...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Sandoval, J. L., Friedlaender, A., Addeo, A. Tags: General Medicine, COVID-19 EBM opinion and debate Source Type: research
Quality of early evidence on the pathogenesis, diagnosis, prognosis and treatment of COVID-19
Since the initial description of the SARS-CoV-2 outbreak and its declaration as a worldwide pandemic, the number of publications on the novel virus has increased rapidly. We studied the trends and quality of evidence in early SARS-CoV-2 publications. A comprehensive search of MEDLINE and EMBASE was performed for papers published between 1 January 2020 and 21 April 2020. Two reviewers independently screened titles and abstracts and subsequently full texts for eligibility in this systematic review. The search yielded 2504 citations published between January and February 2020 or an unspecified date, 109 of which remained for ...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Yang, S., Li, A., Eshaghpour, A., Ivanisevic, S., Salopek, A., Eikelboom, J., Crowther, M. Tags: Primary care, COVID-19 EBM analysis Source Type: research
Dietary Recommendations for Familial Hypercholesterolaemia: an Evidence-Free Zone
We have evaluated dietary recommendations for people diagnosed with familial hypercholesterolaemia (FH), a genetic condition in which increased low-density lipoprotein cholesterol (LDL-C) is associated with an increased risk for coronary heart disease (CHD). Recommendations for FH individuals have emphasised a low saturated fat, low cholesterol diet to reduce their LDL-C levels. The basis of this recommendation is the ‘diet-heart hypothesis’, which postulates that consumption of food rich in saturated fat increases serum cholesterol levels, which increases risk of CHD. We have challenged the rationale for FH di...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Diamond, D. M., Alabdulgader, A. A., de Lorgeril, M., Harcombe, Z., Kendrick, M., Malhotra, A., O'Neill, B., Ravnskov, U., Sultan, S., Volek, J. S. Tags: Open access, Primary care EBM analysis Source Type: research
Evidence-based medicine and machine learning: a partnership with a common purpose
From its origins in epidemiology, evidence-based medicine has promulgated a rigorous approach to assessing the validity, impact and applicability of hypothesis-driven empirical research used to evaluate the utility of diagnostic tests, prognostic tools and therapeutic interventions. Machine learning, a subset of artificial intelligence, uses computer programs to discover patterns and associations within huge datasets which are then incorporated into algorithms used to assist diagnoses and predict future outcomes, including response to therapies. How do these two fields relate to one another? What are their similarities and...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Scott, I., Cook, D., Coiera, E. Tags: General Medicine EBM analysis Source Type: research
Was amorphous aluminium hydroxyphosphate sulfate adequately evaluated before authorisation in Europe?
The Merck Sharp & Dohme Corp aluminium adjuvant ‘amorphous aluminium hydroxyphosphate sulfate’ (AAHS), primarily used in the Gardasil vaccines against human papilloma virus, has been criticised for lack of evidence for its safety. Documentation from Danish authorities and answers from the European Medicines Agency (EMA) suggest that AAHS may not have been sufficiently evaluated. Documentation from the Danish Medicines Agency shows discrepancies in the trial documents of two prelicensure clinical trials with Gardasil in 2002 and 2003. For both trials, the Agency seems to have authorised potassium aluminium s...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Petersen, S. B., Gluud, C. Tags: Open access EBM analysis Source Type: research
Is there a smokers paradox in COVID-19?
Although it is well established that cigarette smoking is associated with morbidity and mortality in several respiratory infections, data from recent studies suggest that active smokers are underrepresented among patients with COVID-19. This has led to claims that a ‘smoker’s paradox’ may exist in COVID-19, wherein smokers are protected from infection and severe complications of COVID-19. We aimed to review and summarise existing literature in this context. Electronic databases were searched for articles that reported prevalence of smokers among patients with COVID-19 or studied any association of smoking...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Usman, M. S., Siddiqi, T. J., Khan, M. S., Patel, U. K., Shahid, I., Ahmed, J., Kalra, A., Michos, E. D. Tags: Primary care, COVID-19 EBM analysis Source Type: research
Hit or miss: the new cholesterol targets
Drug treatment to reduce cholesterol to new target levels is now recommended in four moderate- to high-risk patient populations: patients who have already sustained a cardiovascular event, adult diabetic patients, individuals with low density lipoprotein cholesterol levels ≥190 mg/dL and individuals with an estimated 10-year cardiovascular risk ≥7.5%. Achieving these cholesterol target levels did not confer any additional benefit in a systematic review of 35 randomised controlled trials. Recommending cholesterol lowering treatment based on estimated cardiovascular risk fails to identify many high-risk patients and ma...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: DuBroff, R., Malhotra, A., de Lorgeril, M. Tags: Press releases, Primary care EBM analysis Source Type: research
Should COVID-19 vaccination be mandatory?
Mandates for lockdowns seem to be implemented less hesitantly despite greater uncertainty regarding their supporting evidence and trade-offs. Some countries have recently introduced a new series of restrictions, including military-enforced lockdowns, to reduce the surge of new cases attributable to the spread of the delta variant.1 Lockdowns may be effective tools to reduce the number of cases, and subsequently death attributable to infectious diseases; however, as a complex intervention, there are important uncertainties as to which of its components may be more effective and what are the ideal triggers for implementing a...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Franco, J. V. A. Tags: COVID-19 Editorials Source Type: research
Tramadol: repeated prescriptions and repeated warnings
This article is part of the Coroners’ Concerns to Prevent Harms series.1 It covers the two deaths from tramadol associated with repeat prescribing from two reports to prevent of future deaths.2 3 Rational therapeutics—that is, the safe, effective, and cost-effective use of medicines—requires that the reasons for prescribing a medicine should be reassessed from time to time. Where prescribing in automated systems is deemed ‘routine’ or ‘repeat’ prescribing, it may continue long after the patient benefits from treatment. This exposes the patient to the risk of inadvertent or delibera...
Source: Evidence-Based Medicine - November 25, 2021 Category: Internal Medicine Authors: Cox, A. R., Ferner, R. Tags: General medicine Source Type: research
