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Instruments assessing risk of bias of randomized trials frequently included items that are not addressing risk of bias issues
Objectives: To establish whether items included in instruments published in the last decade assessing risk of bias of randomized controlled trials (RCTs) are indeed addressing risk of bias.Study Design and Setting: We searched Medline, Embase, Web of Science, and Scopus from 2010 to October 2021 for instruments assessing risk of bias of RCTs. By extracting items and summarizing their essential content, we generated an item list. Items that two re-viewers agreed clearly did not address risk of bias were excluded. We included the remaining items in a survey in which 13 experts judged the issue each item is addressing: risk of bias, applicability, random error, reporting quality, or none of the above.Results: Seventeen eligible instruments included 127 unique items. After excluding 61 items deemed as clearly not addressing risk of bias, the item classification survey included 66 items, of which the majority of respondents deemed 20 items (30.3%) as addressing risk of bias; the majority deemed 11 (16.7%) as not addressing risk of bias; and there proved substantial disagreement for 35 (53.0%) items. Conclusion: Existing risk of bias instruments frequently include items that do not address risk of bias. For many items, experts disagree on whether or not they are addressing risk of bias.(c) 2022 Elsevier Inc. All rights reserved.
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Australian general practitioners initiate statin therapy primarily on the basis of lipid levels; New Zealand general practitioners use absolute risk
Objectives To compare the determinants of initial statin prescribing between New Zealand and Australia. New Zealand has a system-wide absolute risk-based approach to primary care cardiovascular disease (CVD) management, while Australia has multiple guidelines. Method Classification and Regression Tree (CART) analysis of two observational studies of primary care CVD management from New Zealand (PREDICT-CVD) and Australia (AusHeart). Over 80% of eligible New Zealanders have been screened for CVD risk. PREDICT-CVD is used by approximately one-third of New Zealand GPs to perform web-based CVD risk assessment in routine practice, with the sample consisting of 126,519 individuals risk assessed between 1 January 2007 and 30 June 2014. AusHeart is a cluster-stratified survey of primary care CVD management that enrolled 534 GPs from across Australia, who in turn recruited 1381 patients between 1 April and 30 June 2008. Eligibility was restricted to 55–74 year old patients without prior CVD. Results The CART analyses demonstrated that New Zealand GPs prescribe statins primarily on the basis of absolute risk, while their Australian counterparts are influenced by a variety of individual risk factors, including total cholesterol, LDL cholesterol and diabetes. Conclusions Countries seeking to improve their management of CVD should consider adopting a ‘whole of system’ absolute risk-based approach with clear guidelines that are consistent with drug reimbursement rules; and include computerized decision-support tools that aid decision-making and allow monitoring of outcomes and continual improvement of practice.
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