Non inferiority
Methods of defining the non inferiority margin in randomized, double blind controlled trials: a systematic review
... define non-inferiority margins, the impact of the FDA draft guidance on the use of the fixed-margin method, and the reporting of the rationale for the choice of the margin in CONSORT-endorsing and ...
9
New Tests for Assessing Non Inferiority and Equivalence from Survival Data
... Rubinstein et al. [7] were probably the first to consider the problem of testing the null hypothesis that the median survival times are equal against an alternative that the median survival time for the experimental ...
10
The use of randomisation based efficacy estimators in non inferiority trials
... two-arm non-inferiority trials, with two active treatments involving patients with long- term conditions whose medication use was monitored throughout the ...of non-inferiority trials ...
11
Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non inferiority, randomized controlled trial
... Methods/design: This prospective, non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin TSB, defined as 3 mg/dl below[r] ...
10
Phase IV non-inferiority trials and additional claims of benefit
... Non-inferiority (NI) trials in drug research are used to demonstrate that a new treatment is not less effective than an active (i.e. effective) comparator [1,2]. Thus, an NI trial, which is mostly defined ...
5
Efficacy and safety of single injection of cross linked sodium hyaluronate vs three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double blind, randomized, multi center, non inferiority study
... proving non-inferiority of XLHA to HMWHA as the lower bound of 95% CI ( − ...was non-inferior to three weekly injections of HMWHA in terms of WBP reduction, and supports XLHA as an effective and safe ...
10
Non inferiority versus superiority drug claims: the (not so) subtle distinction
... of non-inferiority trials suggests that the hypothesis tested is one-sided, and that the statistical test should appropriately be designed as a one-sided ...a non-inferiority claim based on a ...
5
Multicentre study evaluating the non inferiority of the new paediatric formulation of artesunate/amodiaquine versus artemether/lumefantrine for the management of uncomplicated Plasmodium falciparum malaria in children in Cameroon, Ivory Coast and Senegal
... The ACRP at D28 after PCR correction in ITT analysis was 97.6% for AS+AQ versus 94.8% for AL (difference 0.027 95% CI [-0.006; 0.062]) (p= 0.11). In PP analysis, it was 98.7% in AS+AQ arm versus 96.9% in AL arm ...
8
Sample sizes for non-inferiority studies based on the difference between two proportions: a unified approach for difference, ratio and odds ratio models
... for non-inferiority trials with quantitative outcomes [48], and then, together with Kotler, for the ratio between Experimental and Standard probabilities ...a non-inferiority ...
29
A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy
... for non-inferiority trials ...outcomes, non-inferiority was formally investi- gated by calculating the OR (for risk of LBW and placental malaria), or the difference in means (for Hb ...
17
An experienced physiotherapist prescribing and administering corticosteroid and local anaesthetic injections to the shoulder in an Australian orthopaedic service, a non inferiority randomised controlled trial and economic analysis: study protocol for a randomised controlled trial
... test. Non-inferiority of injection by physiotherapist to injection by surgeon will be declared if the upper limit of the one-sided confi- dence interval for the difference in mean change of SPADI in the ...
9
Hysteropexy in the treatment of uterine prolapse stage 2 or higher: a multicenter randomized controlled non-inferiority trial comparing laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy (LAVA-trial, study protocol)
... Methods: The LAVA trial is a randomized controlled multicenter non-inferiority trial. The study compares laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy in women with uterine prolapse ...
7
Efficacy of cloxacillin versus cefazolin for methicillin-susceptible Staphylococcus aureus bacteraemia (CloCeBa): study protocol for a randomised, controlled, non-inferiority trial
... controlled, non-inferiority trial conducted in academic centres throughout ...the non-inferiority of cefazolin over cloxacillin, assuming 85% success rate with cloxacillin and taking into ...
8
The impact of maintaining serum potassium ≥3 6 mEq/L vs ≥4 5 mEq/L on the incidence of new onset atrial fibrillation in the first 120 hours after isolated elective coronary artery bypass grafting – study protocol for a randomised feasibility trial for the proposed Tight K randomized non inferiority trial
... chosen non-inferiority margin of 10% is reasonable and ...smaller non-inferiority margin may make the future full study unviable, due to a significant increase in sample size and ...
9
Quality of reporting of clinical non inferiority and equivalence randomised trials update and extension
... of non- inferiority and equivalence, as well as feasible with re- gard to the extraction ...of non-inferiority and equivalence rando- mised trials [12], the revised CONSORT statement [6], and ...
12
Evaluation of the clinical effectiveness of bioactive glass (S53P4) in the treatment of non unions of the tibia and femur: study protocol of a randomized controlled non inferiority trial
... limb non-unions: a matched pair ana- ...from non-unions of the same anatomical region being treated with Masquelet therapy were evalu- ated regarding their osseous ...binary-outcome ...
9
Through the looking glass: understanding non inferiority
... for non-inferiority trials and superiority ...a non-inferiority trial without assay sensitivity may generate a positive result (that is, it may show evidence of non-inferiority) ...
12
A non-inferiority study to analyze the safety of totally tubeless percutaneous nephrolithotomy
... prove non-inferiority, it must be shown that the CI of the difference between means does not include pre- defined ...the non-inferiority limit of 1 g/dL. Usually, non-inferiority ...
6
Practical guide to sample size calculations: non-inferiority and equivalence trials
... investigate non-inferiority, under the assumption of a small difference between treatments, then the sample size can be calculated for this ...calculated non-inferiority sample size for the ...
20
A multi centre, non inferiority, randomised controlled trial to compare a cervical pessary with a cervical cerclage in the prevention of preterm delivery in women with short cervical length and a history of preterm birth – PC study
... Methods/design: A nationwide open-label multicentre randomised clinical trial will be set up to study women with a singleton pregnancy and a prior preterm birth before 34 weeks of gestation. Women are eligible in case of ...
9