Multiple assessments of non‐inferiority trials with ordinal endpoints
Sign Up to like & getrecommendations! Published in 2023 at "Statistics in Medicine"
DOI: 10.1002/sim.9660
Abstract: Non‐inferiority (NI) trials are implemented when there is a practical demand to search for alternatives to standard therapies, such as to reduce side effects. An experimental treatment is considered non‐inferior to the standard treatment when… read more here.
Keywords: inferiority; latent variable; non inferiority; inferiority trials ... See more keywords
Non-efficacy benefits and non-inferiority margins: a scoping review of contemporary high-impact non-inferiority trials in clinical cardiology
Sign Up to like & getrecommendations! Published in 2021 at "European Journal of Epidemiology"
DOI: 10.1007/s10654-021-00820-x
Abstract: Randomized non-inferiority trials are designed to study whether an experimental treatment (or diagnostic test) is not unacceptably worse in terms of efficacy compared to the standard of care, whilst providing specific advantages over the standard… read more here.
Keywords: non inferiority; cardiology; non efficacy; inferiority ... See more keywords
A confirmatory basket design considering non-inferiority and superiority testing.
Sign Up to like & getrecommendations! Published in 2023 at "Journal of biopharmaceutical statistics"
DOI: 10.1080/10543406.2023.2192781
Abstract: For multiple rare diseases as defined by a common biomarker signature, or a disease with multiple disease subtypes of low frequency, it is often possible to provide confirmatory evidence for these disease or subtypes (baskets)… read more here.
Keywords: inferiority; non inferiority; confirmatory basket; design ... See more keywords
Efficacy of endoxifen, a protein kinase C inhibitor for acute and mixed mania: Some concerns worth considering
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DOI: 10.1111/bdi.13109
Abstract: We read the article by Ahmad et al1 with great interest. The study concluded that endoxifen is efficacious and safe in patients with acute manic episodes with/without mixed features. However, we are worried about internal… read more here.
Keywords: endoxifen protein; non inferiority; efficacy endoxifen; protein kinase ... See more keywords
Comparison of two doses of intrathecal morphine in laparoscopic donor hepatectomy: A randomized double-blinded non-inferiority trial.
Sign Up to like & getrecommendations! Published in 2023 at "Clinical transplantation"
DOI: 10.1111/ctr.14996
Abstract: BACKGROUND Intrathecal morphine (ITM) injection is an effective postoperative analgesic strategy in open or laparoscopic donor hepatectomy; however, the optimal dose has not been determined. In this trial, we compared the post-operative analgesic effects of… read more here.
Keywords: non inferiority; inferiority; donor hepatectomy; laparoscopic donor ... See more keywords
Statistical methods for non-adherence in non-inferiority trials: useful and used? A systematic review
Sign Up to like & getrecommendations! Published in 2022 at "BMJ Open"
DOI: 10.1136/bmjopen-2021-052656
Abstract: Background In non-inferiority trials with non-adherence to interventions (or non-compliance), intention-to-treat and per-protocol analyses are often performed; however, non-random non-adherence generally biases these estimates of efficacy. Objective To identify statistical methods that adjust for the… read more here.
Keywords: inferiority; statistical methods; inferiority trials; non inferiority ... See more keywords
Long versus short peroral endoscopic myotomy for the treatment of achalasia: results of a non-inferiority randomised controlled trial
Sign Up to like & getrecommendations! Published in 2023 at "Gut"
DOI: 10.1136/gutjnl-2021-325579
Abstract: Objective Peroral endoscopic myotomy (POEM) has become standard treatment for achalasia with comparable efficacy to surgery. In most of published series, the length of myotomy is 12–13 cm. Shorter cuts could have the advantage of shorter… read more here.
Keywords: inferiority; endoscopic; poem; trial ... See more keywords
Adaptive non-inferiority margins under observable non-constancy
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DOI: 10.1177/0962280218801134
Abstract: A central assumption in the design and conduct of non-inferiority trials is that the active-control therapy will have the same degree of effectiveness in the planned non-inferiority trial as in the prior placebo-controlled trials used… read more here.
Keywords: active control; constancy assumption; inferiority; non inferiority ... See more keywords
Conversion of non-inferiority margin from hazard ratio to restricted mean survival time difference using data from multiple historical trials
Sign Up to like & getrecommendations! Published in 2022 at "Statistical Methods in Medical Research"
DOI: 10.1177/09622802221102621
Abstract: The restricted mean survival time measure has gained a lot of interests for designing and analyzing oncology trials with time-to-event endpoints due to its intuitive clinical interpretation and potentially high statistical power. In the non-inferiority… read more here.
Keywords: inferiority; time; inferiority margin; conversion ... See more keywords
Swallowing muscle training for oropharyngeal dysphagia: A non-inferiority study of online versus face-to-face therapy.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of telemedicine and telecare"
DOI: 10.1177/1357633x211035033
Abstract: INTRODUCTION The purpose of this study is to show the non-inferiority of the telemedicine therapy versus face-to-face using the exercise therapy of oropharyngeal muscles in 183 patients treated consecutively from 2010 to 2020. METHOD We… read more here.
Keywords: therapy; face; inferiority; study ... See more keywords
Commentary on Bamat et al.
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DOI: 10.1177/1740774520941442
Abstract: This issue of Clinical Trials presents noteworthy insights into protocol adherence and hypothesis confirmation in non-inferiority randomized trials. Noninferiority trials usually compare two interventions with similar expected efficacy, but possible differences in convenience or cost.… read more here.
Keywords: superiority; inferiority trials; non inferiority; hypothesis ... See more keywords