Quality of Reporting of Noninferiority and Equivalence Randomized Trials

Hénanff, Anne Le; Giraudeau, Bruno; Baron, Gabriel; Ravaud, Philippe

doi:10.1001/jama.295.10.1147

Cited by 229 publications

(182 citation statements)

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“…Considering the incidence of laryngeal damage of 0.7% reported by Baillard et al 1 in a population of 565 patients, we assumed equivalence if the difference of the incidences between groups did not exceed 5% in perprotocol analysis, which corresponds to no significant clinical difference. 20 Using Blackwelder's formula:…”

Section: Discussionmentioning

confidence: 99%

“…For analysis of the rates of acceptable intubating conditions and of SLI, per-protocol and intent-totreat analyses were performed. 20 The clinically evaluable population included patients who completed the protocol of anesthesia, who were interviewed for the assessment of laryngeal symptoms, in a standardized way 24 and 48 hr after anesthesia, and whose nasofibroscopic examination could be performed when necessary. All the patients included in this study defined the intent-to-treat population.…”

Section: Discussionmentioning

confidence: 99%

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Laryngeal injuries and intubating conditions with or without muscular relaxation: an equivalence study

Bouvet

Stoian

Jacquot-Laperrière

et al. 2008

Can J Anesth/J Can Anesth

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Purpose:The need for muscular relaxation to improve intubating conditions and to reduce the incidence of laryngeal morbidity is still controversial. The aim of this study was to determine the incidence of symptomatic laryngeal injuries (SLI) and of acceptable intubating conditions (including both good and excellent conditions), both with and without cisatracurium during induction of anesthesia, along with moderate doses of remifentanil and propofol. Methods:In this prospective, randomized double-blind equivalence trial, the intubating conditions were compared in 130 ASA I or II female patients. All subjects received remifentanil 2 µg·kg -1 iv and propofol 2.5 mg·kg -1 iv, with either cisatracurium 0.15 mg·kg -1 iv (group Cisatracturium), or saline (group Placebo). Tracheal intubating conditions were assessed with the Copenhagen Score. A systematic screening for postoperative hoarseness and sore throat was performed 24 and 48 hr after anesthesia, followed by a nasofibroscopic examination when laryngeal symptoms persisted at 48 hr.Results: Twenty-four hr after anesthesia, the incidence of postoperative hoarseness and sore throat in the Cisatracurium and Placebo groups was 26.5% and 21.5%, respectively, and 48 hr after anesthesia, the incidence was 7.8% and 6.1%, respectively (P = 0.32 and P = 0.50 between groups, respectively). In the clinically evaluable population, the incidence of SLI, assessed at 48 hr by nasofibroscopy, was equivalent in both groups, 1.6% vs 1.5% in group Placebo and group Cisatracurium, respectively (P < 0.001 for equivalence test), as was the occurrence of acceptable intubating conditions (95.4% vs 100%, P < 0.05 for equivalence test). However, the occurrence of excellent intubating conditions was more frequent in group Cisatracurium than in group Placebo (P = 0.0003). Conclusion:Following induction of anesthesia with propofol and moderate-dose remifentanil, cisatracurium did not confer a higher rate of good-to-excellent conditions for tracheal intubation, nor did muscle relaxation with cisatracurium decrease the rate of SLI after tracheal intubation.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Laryngeal injuries and intubating conditions with or without muscular relaxation: an equivalence study

Bouvet

Stoian

Jacquot-Laperrière

et al. 2008

Can J Anesth/J Can Anesth

View full text Add to dashboard Cite

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“…Thus, the concept of a noninferiority study design was introduced as a mechanism to establish that a new therapy had efficacy that was similar to, or at least not much worse than (non-inferior to), an established therapy. [2][3][4][5] Electronic supplementary material The online version of this article (doi:10.1007/s12350-017-1034-5) contains supplementary material, which is available to authorized users.…”

Section: Why Perform Non-inferiority Studies?mentioning

confidence: 99%

“…[1][2][3][4][5][6][7][8] The noninferiority margin is the degree to which the new therapy can be less efficacious than the established treatment and still be considered non-inferior. [1][2][3][4][5][6][7][8] The reason for allowing some degree of decreased efficacy and yet consider the new treatment to be non-inferior is that the other advantages (ease of administration, lower cost, or a better side effect profile) would be so beneficial that it would be reasonable to give up a small amount of efficacy to obtain these other benefits. The challenge, however, is that there is no standard criteria to use to establish this non-inferiority margin.…”

Section: Design Considerations For Non-inferiority Studiesmentioning

confidence: 99%

“…Although investigators may choose to attempt to demonstrate superiority of the experimental treatment over the active comparison, in recent years, there has been an increase in the number of clinical trials that simply attempt to demonstrate the non-inferiority of this new therapy. [1][2][3][4][5][6][7][8] In this manuscript, I will summarize the role, design, and interpretation of this type of a clinical trial.…”

Section: Introductionmentioning

confidence: 99%

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Design and interpretation of non-inferiority studies: A clinician’s perspective

Brown

2017

Journal of Nuclear Cardiology

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How to Use a Noninferiority Trial

Mulla¹,

Scott²,

Jackevicius³

et al. 2012

JAMA

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You are an internist seeing a 51-yearold woman with severe osteoarthritis and limited mobility who presents with progressive dyspnea over a 3-day period. She is subjectively in distress, with a pulse rate of 105, a respiratory rate of 28 breaths per minute, and an arterial oxygen saturation of 85% while breathing room air. Aside from her arthritis, the physical examination is unremarkable, and the lower extremity examination shows no sign of deep venous thrombosis. A computed tomographic (CT) pulmonary angiogram reveals unequivocal clot in 2 lobar arteries.Recently, you have been treating patients with deep venous thrombosis without hospital admission using lowmolecular-weight heparin (LMWH) administrationintheoutpatientsetting.You are less comfortable with this approach in the more dangerous setting of pulmonaryembolism.Yourecallreceiving,from the updating service to which you subscribe, a recent trial that addressed this issue. Before discussing the issue of inpatientvsoutpatienttreatmentwithyourpatient, you quickly retire to your office to review the article. 1 In doing so, you find that the trial tested for noninferiority and you wonder, as you begin to read the methods and results, if there are special issues you should consider when using this article to guide your clinical care.

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Quality of Reporting of Noninferiority and Equivalence Randomized Trials

Cited by 229 publications

References 20 publications

Laryngeal injuries and intubating conditions with or without muscular relaxation: an equivalence study

Laryngeal injuries and intubating conditions with or without muscular relaxation: an equivalence study

Design and interpretation of non-inferiority studies: A clinician’s perspective

How to Use a Noninferiority Trial

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