Evid Based Med
· 2017 Dec · PMID 29056603
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Practitioners of evidence-based medicine commonly encounter diagnostic tests with continuous results and no gold standard. In contrast, the traditional critical appraisal teachings assume a binary test (2×2 table) with a...Practitioners of evidence-based medicine commonly encounter diagnostic tests with continuous results and no gold standard. In contrast, the traditional critical appraisal teachings assume a binary test (2×2 table) with a gold standard. In this guide, we use the example of the tuberculin skin test to illustrate a simple approach facilitated by using stratum-specific likelihood ratios and odds of developing future patient-important events. This approach can aid practitioners in the interpretation and application of diagnostic tests to patient care.
Evid Based Med
· 2017 Dec · PMID 29042406
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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...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.
Ponce OJ, Alvarez-Villalobos N, Shah R
… +8 more, Mohammed K, Morgan RL, Sultan S, Falck-Ytter Y, Prokop LJ, Dahm P, Mustafa RA, Murad MH
Evid Based Med
· 2017 Oct · PMID 28924055
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Guidelines often use the term expert opinion (EO) to qualify recommendations. We sought to identify the rationale and evidence type in EO recommendations. We searched multiple databases and websites for contemporary guid...Guidelines often use the term expert opinion (EO) to qualify recommendations. We sought to identify the rationale and evidence type in EO recommendations. We searched multiple databases and websites for contemporary guidelines published in the last decade that used the term EO. We identified 1106 references, of which 69 guidelines were included (2390 recommendations, of which 907 were qualified as EO). A rationale for using EO designation was not provided in most (91%) recommendations. The most commonly cited evidence type was extrapolated from studies that did not answer guideline question (40% from randomised trials, 38% from observational studies and 2% from case reports or series). Evidence extrapolated from populations that were different from those addressed in the guideline was found in 2.5% of EO recommendations. We judged 5.6% of EO recommendations as ones that could have been potentially labelled as good practice statements. None of the EO recommendations were explicitly described as being solely dependent on the clinical experience of the panel. The use of EO as a level of evidence in guidelines remains common. A rationale for such use is not explicitly provided in most instances. Most of the time, evidence labelled as EO was indirect evidence and occasionally was very low-quality evidence derived from case series. We posit that the explicit description of evidence type, as opposed to using the label EO, may add clarity and transparency and may ultimately improve uptake of recommendations.
Evid Based Med
· 2017 Oct · PMID 28866634
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BACKGROUND: The quality of reporting of harms data in randomised controlled trials (RCTs) has been reported to be suboptimal. Rheumatoid arthritis (RA) has seen a massive growth in novel pharmacotherapies in the last dec...BACKGROUND: The quality of reporting of harms data in randomised controlled trials (RCTs) has been reported to be suboptimal. Rheumatoid arthritis (RA) has seen a massive growth in novel pharmacotherapies in the last decade. OBJECTIVE: The aim of this study was to assess the quality of reporting of harms-related data in RCTs evaluating pharmacological interventions for RA according to the CONSORT (Consolidated Standards of Reporting Trials) statement on harms reporting extension. STUDY SELECTION: RCTs published between January 2011 and August 2016 in the five highest impact factor journals in general medicine and two in rheumatology subject categories as per 2015 Journal Citation Reports were included. Reports of secondary, supplementary or exploratory analyses of RCTs and non-inferiority trials were excluded. Two reviewers independently extracted data using a structured, pilot-tested, 18-item questionnaire developed based on CONSORT harms extension recommendations. FINDINGS: 68 RCTs were included in the review. Out of a maximum harms reporting score of 18, the mean (SD) score was 8.51 (3.5) (range=0-15). More than half (56.5%) of the RCTs reported ≤50% of items and only three (4.3%) RCTs reported more than 70% (score ≥14) of the items. Multilinear regression analyses found that region of trial origin (p=0.01), sample size (p=0.001) and whether the study was a long-term extension of a trial or not (p=0.04) were independent predictors associated with higher total harms reporting score. CONCLUSIONS: The adherence to CONSORT harms extension was poor in recently published RCTs of pharmacological interventions for RA. There is a need to improve quality of harms reporting in RCTs to allow transparent and balanced assessment of the benefit-risk ratio in clinical decision making.
Rogozińska E, Marlin N, Thangaratinam S
… +2 more, Khan KS, Zamora J
Evid Based Med
· 2017 Oct · PMID 28818966
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Meta-analysis based on individual participant data (IPD), often described as the 'gold standard' for effectiveness evidence synthesis, is increasingly being deployed despite being more resource intensive than collating s...Meta-analysis based on individual participant data (IPD), often described as the 'gold standard' for effectiveness evidence synthesis, is increasingly being deployed despite being more resource intensive than collating study-level results. Its professed virtues include the ability to incorporate unreported data and to standardise variables and their definitions across trials. In reality, the unreported data, although present in shared datasets, might still not be usable in the analysis. The characteristics of trial participants and their outcomes may be too diversely captured for harmonisation and too time and resource consuming to standardise. Embarking on an IPD meta-analysis can lead to unanticipated challenges which ought to be handled with pragmatism. The aim of this article is to discuss the opportunities created by access to IPD and the practical limitations placed on such meta-analyses, using an international IPD meta-analysis of trials on the effect of lifestyle interventions in pregnancy as an example. Despite the increasing uptake of IPD meta-analysis, they encounter old problems shared by other research methods. When embarking on IPD meta-analysis, it is essential to evaluate the trade-offs between the ambitions, and what is achievable due to constraints imposed by the condition of collected IPD. Furthermore, incorporation of aggregate data from trials where IPD was not available should be a mandatory sensitivity analysis that makes the evidence synthesis up-to-date.
Evid Based Med
· 2017 Oct · PMID 28818963
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Paediatric lipid screening has been recommended for decades to identify youth at increased risk for early atherosclerotic disease but is controversial and not universally adopted. A 2016 review by the US Preventive Servi...Paediatric lipid screening has been recommended for decades to identify youth at increased risk for early atherosclerotic disease but is controversial and not universally adopted. A 2016 review by the US Preventive Services Task Force (USPSTF) found inadequate evidence to recommend for or against lipid screening in childhood. In this Perspective article, we examine this controversial and important topic more broadly. We consider whether the USPSTF framework is asking the right questions, and whether the answers to these questions should be valued equally, whether the USPSTF questions are answerable and by what types of evidence and whether the burden of proof is appropriate. We argue that using a broader framework that includes the magnitude of potential benefits and harms, considering more types of evidence beyond randomised controlled trials, and more fully incorporating patient and parent perspectives could lead to more practical and more widely applicable guidance for practitioners, guide future research priorities and be more inclusive of patient priorities.