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 define non-inferiority margins, the impact of the FDA draft guidance on the use of the fixed-margin method, and the reporting of the rationale for the choice of the margin in CONSORT-endorsing and ...
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Quality of reporting of clinical non inferiority and equivalence randomised trials update and extension
... as non-inferiority or equivalence trials based on title or abstract, but less than half of the reports gave a rationale for the design or the expected ...The non-inferiority or equivalence ...
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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 number of patients to be included in this study was determined using Epi info software version 6.04d [7], On the basis of previous studies, the cure rate of AL was estimated at 95% [8,9]. The maximal difference ...
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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
... Potassium plays an important role in cardiac electro- physiology [12]. Serum concentrations ([K + ]) are com- monly low following cardiac surgery [13], and appear marginally lower in in non-surgical cohorts among ...
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The use of randomisation based efficacy estimators in non inferiority trials
... This paper investigated the use of randomisation-based efficacy estimators in non-inferiority trials. Structural mean models were fitted using a method proposed by Fischer et al., where baseline variables ...
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Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non inferiority trial
... The study’s central hypothesis will be tested by com- paring change in the CM score between the two groups for the intervention shoulder Appendix 1. To compare independent variables between the two groups, the Student’s ...
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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
... addition, non-union of a fracture can also lead to debilitating economic and social circumstances ...develop non-unions [1, 3, ...infected non-unions, as well as large defect sizes, re- mains a ...
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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 ...
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New Tests for Assessing Non Inferiority and Equivalence from Survival Data
... and non-inferiority of an experimental ther- apy compared to a reference therapy in terms of their median survival ...assessing non-inferiority in terms of the difference between median ...
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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
... (and non-randomised) clinical trial compared physiotherapist management of selected orthopaedic referrals to that of junior doctors and included physiotherapist corticoster- oid injection as a treatment ...
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Excess risk of preterm birth with periconceptional iron supplementation in a malaria endemic area: analysis of secondary data on birth outcomes in a double blind randomized controlled safety trial in Burkina Faso
... This trial provides evidence that long-term iron supple- mentation leads to excess PTB in a malaria endemic area, predominantly associated with the malaria transmission season, with the risk of delivery under 37 weeks of ...
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Comparison of SCAphoid fracture osteosynthesis by MAGnesium based headless Herbert screws with titanium Herbert screws: protocol for the randomized controlled SCAMAG clinical trial
... Headless compression screws are considered to be particularly well suited for surgical therapy of recent frac- tures [6], which can be inserted through both palmar and dorsal approaches. Most frequently, ...
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Cadazolid for the treatment of Clostridium difficile infection: results of two double-blind, placebo-controlled, non-inferiority, randomised phase 3 trials
... double-dummy, non-inferiority, randomised, controlled phase 3 ...was non-inferiority (margin -10%) of cadazolid versus vancomycin for clinical cure (CC) in the modified intent-to-treat (mITT) ...
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Non inferiority versus superiority drug claims: the (not so) subtle distinction
... The PRECISION trial [14] compared the cardiovascular safety of celecoxib to the nonselective nonsteroidal anti-inflammatory drugs naproxen and ibuprofen. The primary endpoint was the first occurrence of death from ...
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Methods for conducting a double blind randomized controlled clinical trial of three days versus five days of amoxicillin dispersible tablets for chest indrawing childhood pneumonia among children two to 59 months of age in Lilongwe, Malawi: a study protocol
... randomized, non-inferiority trial with the objective to assess the effectiveness of shorter duration amoxicillin dispersible tablet (DT) treatment of chest indrawing childhood pneumonia in a malaria- ...
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A cluster randomized controlled non-inferiority trial of 5-day Dose Adjustment for Normal Eating ( DAFNE) training delivered over 1 week versus 5-day DAFNE training delivered over 5 weeks: the DAFNE 5 x 1-day trial
... The sample size was calculated to test non-inferiority between the two different course delivery formats. Based on a non-inferiority margin in HbA1c level of 5.5 mmol/mol (0.5%), a standard ...
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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
... A cervical cerclage is considered to be effective in the prevention of preterm birth in women with cervical insufficiency and/or short cervix during pregnancy with a previous preterm birth. However, it is associated with ...
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SUrgical versus PERcutaneous Bypass: SUPERB trial; Heparin bonded endoluminal versus surgical femoro popliteal bypass: study protocol for a randomized controlled trial
... Methods/design: Two-hundred-twenty-two patients with peripheral arterial occlusive disease, category 3-6 according to Rutherford, will be randomized in two treatment arms; 1. the surgical femoro-popliteal bypass, venous ...
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Systematic literature review and meta analysis of the efficacy of artemisinin based and quinine based treatments for uncomplicated falciparum malaria in pregnancy: methodological challenges
... Background: There is no agreed standard method to assess the efficacy of anti-malarials for uncomplicated falcipa- rum in pregnancy despite an increased risk of adverse outcomes for the mother and the fetus. The aim of ...
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Randomized clinical trials to identify optimal antibiotic treatment duration
... It should be noted that equal allocation of subjects to the standard regimen group and the combined Regimen A treatment groups (as was done in these simulations) may not provide the most power to show ...
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