Annals of internal medicine
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Target trial emulation is an approach to designing rigorous nonexperimental studies by "emulating" key features of a clinical trial. Most commonly used outside of policy contexts, this approach is also valuable for policy evaluation as policies typically are not randomly assigned. ⋯ Policy evaluations that emulate a randomized trial across these dimensions can yield estimates of the causal effects of the policy on outcomes. Using the policy trial emulation framework to conduct and report on research design and methods supports transparent assessment of threats to causal inference in nonexperimental studies intended to assess the effect of a health policy on clinical or population health outcomes.
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Meta Analysis
In T2D, SGLT-2 inhibitor effects on CV and kidney outcomes were consistent regardless of GLP-1 receptor agonist use.
Apperloo EM, Neuen BL, Fletcher RA, et al. Efficacy and safety of SGLT2 inhibitors with and without glucagon-like peptide 1 receptor agonists: a SMART-C collaborative meta-analysis of randomised controlled trials. Lancet Diabetes Endocrinol. 2024;12:545-557. 38991584.
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Nearly all medical devices reviewed by the U. S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. ⋯ Advocates of the 510(k) clearance process tout its support for device innovation and rapid market access, and critics of the 510(k) clearance process express that it may inadequately protect patient safety. In September 2023, the FDA issued 3 guidance documents that, if finalized, would significantly change medical device regulation. This article provides clinical and regulatory context for the proposed guidance documents, which focus on predicate selection, clinical testing requirements, and implantable devices, and identifies opportunities for further reforms that promote transparency and patient safety.
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Randomized Controlled Trial
In adults with BMI ≥27 kg/m2 and CVD, but without diabetes, semaglutide reduced MACE, regardless of baseline HbA1c level.
Lingvay I, Deanfield J, Kahn SE, et al; SELECT Trial Investigators. Semaglutide and cardiovascular outcomes by baseline HbA1c and change in HbA1c in people with overweight or obesity but without diabetes in SELECT. Diabetes Care. 2024;47:1360-1369. 38907684.
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Louis E, Schreiber S, Panaccione R, et al; INSPIRE and COMMAND Study Group. Risankizumab for ulcerative colitis: two randomized clinical trials. JAMA. 2024;332:881-897. 39037800.