An effective treatment already exists for many diseases. In these cases the effectiveness of a new treatment may be established by showing that the new treatment is as effective as (i.e., equivalent to) or at least as effective as (i.e., noninferior to) the old treatment. For an economic evaluation accompanying a clinical equivalence or noninferiority trial it is important to decide before the start of the study on the appropriate research question. In many cases the objective of the economic evaluation will be to show equivalence or noninferiority of the cost-effectiveness of the treatments. This has major implications for the design and analysis of the economic evaluation. In this article we propose methods for the analysis of economic equivalence and noninferiority studies that are similar to the methods applied to clinical equivalence and noninferiority trials. Furthermore, cost-effectiveness planes prove to be a valuable tool in the interpretation of the results in an economic equivalence or noninferiority trial. The concepts described in the article are illustrated using the results from an economic noninferiority trial.
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http://dx.doi.org/10.1111/j.1524-4733.2007.00245.x | DOI Listing |
Anesth Analg
February 2025
From the Department of Surgical Specialties and Anesthesiology of São Paulo State University (UNESP), Medical School, Botucatu, Brazil.
Background: Proficiency in endotracheal intubation (ETI) is essential for medical professionals and its training should start at medical schools; however, large caseload may be required before achieving an acceptable success rate with direct laryngoscopy. Video laryngoscopy has proven to be an easier alternative for intubation with a faster learning curve, but its availability in medical training may be an issue due to its high market prices. We devised a low-cost 3-dimensionally printed video laryngoscope (3DVL) and performed a randomized trial to evaluate if the intubation success rate on the first attempt with this device is noninferior to a standard commercially available video laryngoscope (STVL).
View Article and Find Full Text PDFMedicine (Baltimore)
January 2025
Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Background: This study evaluates the efficacy and safety of sitagliptin versus gliclazide, combined with metformin, in treatment-naive patients with type 2 diabetes mellitus (T2DM) and glucotoxicity.
Methods: In this single-center, randomized, controlled noninferiority trial, 129 treatment-naive patients with T2DM with glucotoxicity (fasting plasma glucose [FPG] ≥ 200 mg/dL and glycated hemoglobin ≥ 9.0%) were randomized to receive sitagliptin plus metformin (n = 66) or gliclazide plus metformin (n = 63) for 12 weeks.
EuroIntervention
January 2025
Department of Advanced Biomedical Sciences, University of Naples "Federico II", Naples, Italy.
Background: Few data are available on polymer-free drug-eluting stents in patients undergoing percutaneous coronary intervention (PCI).
Aims: We aimed to determine the efficacy and safety of a polymer-free amphilimus-eluting stent (AES), using a reservoir-based technology for drug delivery, compared with a biodegradable-polymer everolimus-eluting stent (EES).
Methods: This was a randomised, investigator-initiated, assessor-blind, non-inferiority trial conducted at 14 hospitals in Italy (ClinicalTrials.
BMJ Open
January 2025
Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.
Introduction: Omalizumab, an anti-IgE monoclonal antibody, is effective in treating antihistamine-refractory chronic spontaneous urticaria (CSU). However, tapering strategies for omalizumab are currently not well-studied, and patients may be treated longer than needed. Here, we present the rationale and design of the EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria trial, a multicentre, randomised, open-label, non-inferiority clinical trial.
View Article and Find Full Text PDFBiomed Phys Eng Express
January 2025
Department of Neurology and Neurological Sciences, Stanford University, Palo Alto, CA, United States of America.
Clinical adoption of innovative EEG technology is contingent on the non-inferiority of the new devices relative to conventional ones. We present the four key results from testing the signal quality of Zeto's WR 19 EEG system against a conventional EEG system conducted on patients in a clinical setting.We performed 30 min simultaneous recordings using the Zeto WR 19 (zEEG) and a conventional clinical EEG system (cEEG) in a cohort of 15 patients.
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