Authors:Jefferson T. Pages: 189 - 190 Abstract: This is the second in a series of notes addressing the need to change our evidence sources for assessing the effects of pharmaceuticals and biologics because of the danger of unrecognised reporting bias. In this note I shall discuss the possibility of using a shorter way of redefining the E than using clinical study reports. In the first note—‘Redefining the ‘E’ in EBM’— I made the point that trial publications (if they exist) are the tip of the data iceberg.1 The ‘iceberg’ is made up of a complex and massive reality of thousands of pages of clinical study reports, manuals, forms and slides of meetings invisible below the waterline. The submerged part is likely to represent anything between 1 and 8000 pages of published material.2 Even more importantly, the submerged material has the potential to change the conclusions of systematic reviews. To prove this point... Keywords: Editor's choice, General Medicine PubDate: 2020-11-23T00:46:48-08:00 DOI: 10.1136/bmjebm-2020-111348 Issue No:Vol. 25, No. 6 (2020)
Authors:Hawkes D. Pages: 191 - 192 Abstract: Since the introduction of vaccines against certain types of human papillomavirus (HPV), there have been concerns voiced by those critical of the use of these vaccines. These arguments often follow similar patterns and use similar discussion approaches such as raising unfounded questions about safety or using ‘scary’ terms without context (eg, toxins). A recent manuscript by Little and Ward1 provided a representative example of the type of arguments made by vaccine critics that appear to have merit on first examination but which fail when more thoroughly investigated,2 and especially over time as the evidence base demonstrating vaccine safety increases.3 4 Little and Ward, like many other critics of the HPV vaccine, raise the issue of toxicity. In particular, they raise concerns about Polysorbate 80 and its relationship with infertility. They state that up to the age of 12, children receive a... Keywords: Open access, Primary care PubDate: 2020-11-23T00:46:48-08:00 DOI: 10.1136/bmjebm-2019-111222 Issue No:Vol. 25, No. 6 (2020)
Authors:
McCaul, M; Ernstzen, D, Temmingh, H, Draper, B, Galloway, M, Kredo, T. Pages: 193 - 198 Abstract: Developing a clinical practice guideline (CPG) is expensive and time-consuming and therefore often unrealistic in settings with limited funding or resources. Although CPGs form the cornerstone of providing synthesised, systematic, evidence-based guidance to patients, healthcare practitioners and managers, there is no added benefit in developing new CPGs when there are accessible, good-quality, up-to-date CPGs available that can be adapted to fit local needs. Different approaches to CPG development have been proposed, including adopting, adapting or contextualising existing high-quality CPGs to make recommendations relevant to local contexts. These approaches are attractive where technical and financial resources are limited and high-quality guidance already exists. However, few examples exist to showcase such alternative approaches to CPG development. The South African Guidelines Excellence project held a workshop in 2017 to provide an opportunity for dialogue regarding different approaches to guideline development with key examples and case studies from the South African setting. Four CPGs represented the topics: mental health, health promotion, chronic musculoskeletal pain and prehospital emergency care. Each CPG used a different approach, however, using transparent, reportable methods. They included advisory groups with representation from content experts, CPG users and methodologists. They assessed CPGs and systematic reviews for adopting or adapting. Each team considered local context issues through qualitative research or stakeholder engagement. Lessons learnt include that South Africa needs fit-for-purpose guidelines and that existing appropriate, high-quality guidelines must be taken into account. Approaches for adapting guidelines are not clear globally and there are lessons to be learnt from existing descriptions of approaches from South Africa. Keywords: Open access, Emergency care PubDate: 2020-11-23T00:46:48-08:00 DOI: 10.1136/bmjebm-2019-111192 Issue No:Vol. 25, No. 6 (2020)
Authors:
Osborne, V; Davies, M, Roy, D, Tescione, F, Shakir, S. A. W. Pages: 199 - 205 Abstract: BackgroundPrior to approval in the European Union, a systematic benefit-risk assessment was required to compare buprenorphine implant to sublingual buprenorphine as part of the license application to the European Medicines Agency.ObjectiveThe Benefit-Risk Action Team framework was used to describe the overall benefit-risk of buprenorphine implant in comparison to sublingual buprenorphine.Study selection/methodsA value tree of key benefits and risks related to the implant formulation of buprenorphine was constructed. Risk differences (RD) or reporting ORs (ROR) and corresponding 95% CIs were calculated for each outcome, along with the number needed to treat and number needed to harm. Swing weighting was assigned to outcomes and the weighted net clinical benefit (wNCB) was calculated.FindingsKey benefits assessed: reduced risk of illicit opioid use (RD=0.09, 95% CI 0.01 to 0.17), reduced risk of misuse and diversion (ROR=0.13, 95% CI 0.02 to 0.94), improved compliance and convenience (RD=0.20) and quality of life measures (RD=0.03). Key risks assessed: clinically significant implant breakage (RD=0.01, 95% CI 0.00 to 0.01), migration/missing implant (RD=0.01, 95% CI 0.00 to 0.02), infection at insertion/removal site (RD=0.08, 95% CI 0.03 to 0.12) and implant-related allergic reaction (RD=0.07, 95% CI 0.03 to 0.11). The wNCB for buprenorphine implant was 4.96, which suggests a favourable benefit-risk profile.ConclusionsThe benefit-risk profile of buprenorphine implant is considered favourable in comparison to sublingual buprenorphine, based on this semiquantitative analysis using available data. Further data from real-world use on benefits and risks should be used for ongoing monitoring of the benefit-risk profile of buprenorphine implants in the postmarketing setting. Keywords: Open access, General Medicine PubDate: 2020-11-23T00:46:48-08:00 DOI: 10.1136/bmjebm-2019-111295 Issue No:Vol. 25, No. 6 (2020)
Authors:
Thongprayoon, C; Cheungpasitporn, W, Hansrivijit, P, Thirunavukkarasu, S, Chewcharat, A, Medaura, J, Mao, M. A, Kashani, K. B. Pages: 206 - 212 Abstract: The objective of this study was to assess the association of in-hospital mortality risk based on change in serum magnesium levels in hospitalised patients. All adult patients admitted to our hospital from years 2009 to 2013 with at least two serum magnesium measurements during hospitalisation were included. Serum magnesium change, defined as the absolute difference between the highest and lowest serum magnesium, was categorised into six groups: 0–0.2, 0.3–0.4, 0.5–0.6, 0.7–0.8, 0.9–1.0, ≥1.1 mg/dL. In-hospital mortality was the outcome of interest. Logistic regression was used to assess the association between serum magnesium change and in-hospital mortality, using serum magnesium change of 0.0–0.2 mg/dL as the reference group. A total of 42 141 patients, with the median serum magnesium change during hospital stay of 0.3 (IQR 0.2–0.6) mg/dL, were studied. In-hospital mortality based on serum magnesium change of 0–0.2, 0.3–0.4, 0.5–0.6, 0.7–0.8, 0.9–1.0, ≥1.1 mg/dL was 1.3%, 2.3%, 3.1%, 5.0%, 6.5%, and 8.8%, respectively (p Keywords: General Medicine PubDate: 2020-11-23T00:46:48-08:00 DOI: 10.1136/bmjebm-2019-111322 Issue No:Vol. 25, No. 6 (2020)
Authors:
Doshi, P; Bourgeois, F, Hong, K, Jones, M, Lee, H, Shamseer, L, Spence, O, Jefferson, T. Pages: 213 - 219 Abstract: PurposeTrustworthy reporting of quadrivalent human papillomavirus (HPV) vaccine trials is the foundation for assessing the vaccine’s risks and benefits. However, several pivotal trial publications incompletely reported important methodological details and inaccurately described the formulation that the control arms received. Under the Restoring Invisible and Abandoned Trials initiative (RIAT), we aim to restore the public record regarding the content and rationale of the controls used in the trials.MethodsWe assembled a cohort (five randomised controlled trials) described as placebo-controlled using clinical study reports (CSRs) obtained from the European Medicines Agency. We extracted the content and rationale for the choice of control used in each trial across six data sources: trial publications, register records, CSR synopses, CSR main bodies, protocols and informed consent forms.ResultsAcross data sources, the control was inconsistently reported as ‘placebo’-containing aluminium adjuvant (sometimes with dose information). Amorphous aluminium hydroxyphosphate sulfate (AAHS) was not mentioned in any trial registry entry, but was mentioned in all publications and CSRs. In three of five trials, consent forms described the control as an ‘inactive’ substance. No rationale for the selection of the control was reported in any trial publication, register, consent form, CSR synopsis or protocol. Three trials reported the rationale for choice of control in CSRs: to preserve blinding and assess the safety of HPV virus-like particles as the ‘safety profile of (AAHS) is well characterised’.ConclusionsThe stated rationale of using AAHS control—to characterise the safety of the HPV virus-like particles—lacks clinical relevance. A non-placebo control may have obscured an accurate assessment of safety and the participant consent process of some trials raises ethical concerns.Trial registration numbers NCT00092482, NCT00092521, NCT00092534, NCT00090220, NCT00090285. Keywords: Open access, General Medicine PubDate: 2020-11-23T00:46:48-08:00 DOI: 10.1136/bmjebm-2019-111331 Issue No:Vol. 25, No. 6 (2020)
Authors:Onakpoya I. J. Pages: 220 - 220 Abstract: Results of observational studies suggest that beta-blockers have a role in preventing acute exacerbations of COPD, however a recent randomised controlled trial demonstrates it may cause more harm than good. Acute exacerbations of chronic obstructive pulmonary disease (COPD) are a major contributor to morbidity and mortality. Reductions in the frequency and severity of such exacerbations improve long-term clinical outcomes and quality of life.1 Previous meta-analyses of observational studies have suggested that beta-blockers may be beneficial in the management of COPD.2 3 The BLOCK COPD (Beta-Blockers for the Prevention of Acute Exacerbations of COPD) study was a multicentre, randomised, placebo-controlled clinical trial (n=532) that assessed the effectiveness of extended-release metoprolol (a beta-1 selective adrenergic receptor blocker) in preventing acute exacerbations in adults with moderate or severe COPD (aged 40–85 years).4 The primary outcome was time until first exacerbation. Secondary outcomes included hospitalisations,... Keywords: Editor's choice, Primary care, EBM Verdict PubDate: 2020-11-23T00:46:48-08:00 DOI: 10.1136/bmjebm-2019-111313 Issue No:Vol. 25, No. 6 (2020)
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