noninferiority margin
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2022 ◽  
Vol 79 (1) ◽  
pp. 31-34
Author(s):  
Lauren E. Mamer ◽  
William J. Meurer

Author(s):  
Tammy M. Brady ◽  
Jeanne Charleston ◽  
Junichi Ishigami ◽  
Edgar R. Miller ◽  
Kunihiro Matsushita ◽  
...  

A rest period of 3 to 5 minutes before blood pressure (BP) measurement is recommended in hypertension guidelines but can be challenging to implement. We conducted a randomized trial to determine the effects of resting for <5 minutes on BP. In a cross-over design, 113 participants (mean age 55 years, 36% male, 75% Black) had 4 sets of triplicate BP measurements with the order of rest for the first 3 sets (0 minutes, 2 minutes, 5 minutes 1 ) randomized. The fourth set was always a second 5-minute rest period (5 minutes 2 ), from which we calculated the difference between 5 minutes 1 and 5 minutes 2 (5 minutes 1 −5 minutes 2 ), a measure of intrinsic BP variability. To determine if there was no difference between BPs obtained after resting 0 minutes or 2 minutes versus 5 minutes 1 , we tested whether 5 minutes 1 −0 minutes or 5 minutes 1 −2 minutes was within a prespecified noninferiority margin of ±2 mm Hg compared with 5 minutes 1 −5 minutes 2 . Overall, mean BP was similar across 5 minutes 1 (128/75), 5 minutes 2 (127/76), 2 minutes (127/74), and 0 minutes (127/74). Compared with the average absolute 5 minutes 1 −5 minutes 2 difference (5.3/3.0 mm Hg), the absolute systolic BP difference of differences did not cross our noninferiority margin for 0 minutes rest (0.2 [95% CI, 0.8–1.2]) but did for 2 minutes rest (−1.7 [−2.8 to −0.6]). Among those with systolic BP <140, the absolute difference of differences for both 0 and 2 minutes did not cross the ±2 mm Hg margin; however, those with systolic BP ≥140 had differences that did exceed this threshold. Our findings suggest that shorter rest periods may be a reasonable alternative to 5 minutes for most individuals. Implementation could substantially improve the efficiency of hypertension screening programs. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04031768.


2021 ◽  
pp. 247412642110278
Author(s):  
Nicole H. Siegel ◽  
Marissa G. Fiorello ◽  
Steven Ness ◽  
Jiwoo Kim ◽  
Viha Vig ◽  
...  

Purpose: This work aims to determine whether patient satisfaction with oral sedation is noninferior to intravenous (IV) sedation in vitrectomy surgery. Methods: This prospective, randomized, double-masked, noninferiority clinical trial measured patient satisfaction in 84 participants receiving oral or IV sedation during vitrectomy surgery under monitored anesthesia care. Patients were excluded if they were unable to receive benzodiazepines. Results: The primary outcome was patient satisfaction. Secondary outcomes included surgeon and anesthesia provider satisfaction, need for supplemental anesthesia, and surgical complications. Among the 84 patients (46 [54.8%] men; mean [SD] age, 57.0 [12.7 years]), mean patient satisfaction scores were 5.22 ± 0.81 (range, 3.08-6; scale 1-6) with oral and 5.25 ± 0.63 (range, 3.83-6; scale 1-6) with IV sedation. With an a priori noninferiority margin of 0.5 and a difference in mean scores between the groups of 0.03 (1-tailed 95% CI, infinity to 0.29), our results demonstrated the noninferiority of oral sedation ( P = .002). There were no significant differences in surgeon or anesthesia satisfaction or major intraoperative complications. Five patients receiving oral (11.9%) and 3 receiving IV (7.1%) sedation required supplemental IV sedation (difference, 4.8%; P = .46). Conclusions: Patient satisfaction for oral sedation was noninferior to IV sedation for vitrectomy surgery.


2021 ◽  
pp. 1358863X2110211
Author(s):  
Olesia Osipova ◽  
Alexey Cheban ◽  
Pavel Ignatenko ◽  
Pavel Ruzankin ◽  
Evgeny Prokopenko ◽  
...  

Introduction Concurrent stenting of complex iliac lesions during infrainguinal bypasses can increase the complexity of a case and impact outcomes. Objective Our aim was to evaluate the effect of inflow stenting of TASC-II C, D iliac lesions on femoropopliteal bypass patency. Methods A retrospective observational cohort study of patients who underwent femoropopliteal bypass with TASC-II C, D iliac artery stenting (hybrid group) or without inflow lesions (non-hybrid group) was conducted. After propensity score matching, 120 patients were included in the non-hybrid group and 60 patients in the hybrid one. The median follow-up was 432 (193; 1313) days in the hybrid group and 472 (196; 1376) days in the non-hybrid group ( p = 0.94). Results No significant differences were found between the groups in 30-day morbidity and serious adverse events. At 3 years, primary and secondary bypass patency for the hybrid group and non-hybrid group were 62.2% versus 59.9% ( p = 0.36) and 63.7% versus 64.3% ( p = 0.077), respectively. The primary patency of the iliac stents in patients of the hybrid group was 95% at 3 years. The estimated hazard ratio for primary patency for hybrid versus non-hybrid was 0.77, with 90% CI: 0.50–1.21; the noninferiority upper bound being 1.31, which corresponds to a 10% additive noninferiority margin for probabilities. The 3 years of freedom from amputation in patients with chronic limb-threatening ischemia was 94.1% and 75.0% in the hybrid and non-hybrid groups, respectively ( p = 0.09). Conclusion The outcomes of the femoropopliteal bypass in hybrid surgery supplemented with stenting of TASC-II C, D iliac lesions was similar to femoropopliteal bypass with intact inflow arteries.


2021 ◽  
Vol 10 (6) ◽  
pp. 443-455
Author(s):  
Mahmoud Hashim ◽  
Talitha Vincken ◽  
Florint Kroi ◽  
Samron Gebregergish ◽  
Mike Spencer ◽  
...  

Aim: A systematic literature review was conducted to identify and characterize noninferiority margins for relevant end points in oncology clinical trials. Materials & methods: Randomized, controlled, noninferiority trials of patients with cancer were identified in PubMed and Embase. Results: Of 2284 publications identified, 285 oncology noninferiority clinical trials were analyzed. The median noninferiority margin was a hazard ratio of 1.29 (mean: 1.32; range: 1.05–2.05) for studies that reported time-to-event end points (n = 192). The median noninferiority margin was 13.0% (mean: 12.7%; range: 5.0–20.0%) for studies that reported response end points as absolute rate differences (n = 31). Conclusion: Although there was consistency in the noninferiority margins’ scale, variability was evident in noninferiority margins across trials. Increased transparency may improve consistency in noninferiority margin application in oncology clinical trials.


Author(s):  
Richard G Wunderink ◽  
Antoine Roquilly ◽  
Martin Croce ◽  
Daniel Rodriguez Gonzalez ◽  
Satoshi Fujimi ◽  
...  

Abstract Background Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) are associated with high mortality rates. We evaluated the efficacy and safety of tedizolid (administered as tedizolid phosphate) for treatment of gram-positive ventilated HABP/VABP. Methods In this randomized, noninferiority, double-blind, double-dummy, global phase 3 trial, patients were randomized 1:1 to receive intravenous tedizolid phosphate 200 mg once daily for 7 days or intravenous linezolid 600 mg every 12 hours for 10 days. Treatment was 14 days in patients with concurrent gram-positive bacteremia. The primary efficacy end points were day 28 all-cause mortality (ACM; noninferiority margin, 10%) and investigator-assessed clinical response at test of cure (TOC; noninferiority margin, 12.5%) in the intention-to-treat population. Results Overall, 726 patients were randomized (tedizolid, n = 366; linezolid, n = 360). Baseline characteristics, including incidence of methicillin-resistant Staphylococcus aureus (31.3% overall), were well balanced. Tedizolid was noninferior to linezolid for day 28 ACM rate: 28.1% and 26.4%, respectively (difference, –1.8%; 95% confidence interval [CI]: –8.2 to 4.7). Noninferiority of tedizolid was not demonstrated for investigator-assessed clinical cure at TOC (tedizolid, 56.3% vs linezolid, 63.9%; difference, –7.6%; 97.5% CI: –15.7 to 0.5). In post hoc analyses, no single factor accounted for the difference in clinical response between treatment groups. Drug-related adverse events occurred in 8.1% and 11.9% of patients who received tedizolid and linezolid, respectively. Conclusions Tedizolid was noninferior to linezolid for day 28 ACM in the treatment of gram-positive ventilated HABP/VABP. Noninferiority of tedizolid for investigator-assessed clinical response at TOC was not demonstrated. Both drugs were well tolerated. Clinical Trials Registration NCT02019420.


Author(s):  
Jason S Melo ◽  
Solomon Aragie ◽  
Ambahun Chernet ◽  
Zerihun Tadesse ◽  
Adane Dagnew ◽  
...  

Abstract Background Current guidelines recommend community-wide mass azithromycin for trachoma, but a targeted treatment strategy could reduce the volume of antibiotics required. Methods In total, 48 Ethiopian communities were randomized to mass, targeted, or delayed azithromycin distributions. In the targeted arm, only children aged 6 months to 5 years with evidence of ocular chlamydia received azithromycin, distributed thrice over the following year. The primary outcome was ocular chlamydia at months 12 and 24, comparing the targeted and delayed arms (0–5 year-olds, superiority analysis) and the targeted and mass azithromycin arms (8–12 year-olds, noninferiority analysis, 10% noninferiority margin). Results At baseline, the mean prevalence of ocular chlamydia in the 3 arms ranged from 7% to 9% among 0–5 year-olds and from 3% to 9% among 8–12 year-olds. Averaged across months 12–24, the mean prevalence of ocular chlamydia among 0–5 year-olds was 16.7% (95% confidence interval [CI]: 9.0%–24.4%) in the targeted arm and 22.3% (95% CI: 11.1%–33.6%) in the delayed arm (P = .61). The final mean prevalence of ocular chlamydia among 8–12 year-olds was 13.5% (95% CI: 7.9%–19.1%) in the targeted arm and 5.5% (95% CI: 0.3%–10.7%) in the mass treatment arm (adjusted risk difference 8.5 percentage points [pp] higher in the targeted arm, 95% CI: 0.9 pp–16.1 pp higher). Conclusions Antibiotic treatments targeted to infected preschool children did not result in significantly less ocular chlamydia infections compared with untreated communities and did not meet noninferiority criteria relative to mass azithromycin distributions. Targeted approaches may require treatment of a broader segment of the population in areas with hyperendemic trachoma.


2021 ◽  
Vol 16 (1) ◽  
pp. 59-63
Author(s):  
Hee Jong Ki ◽  
Bum-soo Kim ◽  
Jun-Ki Kim ◽  
Jai Ho Choi ◽  
Yong Sam Shin ◽  
...  

Purpose: Three-dimensional (3D) measurement of intracranial aneurysms is important in planning endovascular treatment, and 3D rotational angiography (RA) is effective in accurate measurement. The purpose of this study was to evaluate the feasibility of low dose 3D RA (5 seconds 0.10 μGy/frame) in measuring an intracranial aneurysm using an in vitro phantom.Materials and Methods: We investigated an <I>in vitro</i> 3D phantom of an intracranial aneurysm with 10 acquisitions of 3D RA with a conventional dose (5 seconds 0.36 μGy/frame) and 10 acquisitions with a low-dose (5 seconds 0.10 μGy/frame). 3D size and neck diameters of the aneurysm were measured and compared between the 2 groups (conventional and low-dose) using noninferiority statistics.Results: The aneurysm measurements were well-correlated between the 2 readers, and noninferiority in the measurement of aneurysmal size of low-dose 3D RA was demonstrated, as the upper margin of the 1-sided 97.5% confidence interval did not cross the pre-defined noninferiority margin of 0.2 mm by the 2 readers.Conclusion: Low-dose (5 seconds 0.10 μGy/frame) cerebral 3D RA is technically feasible and not inferior in in vitro 3D measurement of an intracranial aneurysm. Thus, low-dose 3D RA is promising and needs further evaluation for its clinical utility in the planning of endovascular treatment of an intracranial aneurysm.


2021 ◽  
Vol 39 (7) ◽  
pp. 861-862
Author(s):  
Vinod Sharma ◽  
Akash Kumar

Author(s):  
Alexandr Y Mayorov ◽  
Anna A Mosikian ◽  
Diana N Alpenidze ◽  
Igor E Makarenko ◽  
Valeria L Orlova ◽  
...  

Aim: To compare safety (immunogenicity) and efficacy of a biosimilar insulin GP-Lis25 and a reference insulin Ly-Lis25 (Humalog Mix 25) in Type 2 diabetes mellitus (T2D) patients. Materials & methods: This randomized open-label, 26-week clinical trial enrolled 210 T2D patients, randomized 1:1 to twice-daily GP-Lis25 or Ly-Lis25. The primary end point was immune response at 26th week. Noninferiority margin for HbA1c was 0.4%. Results: Immune response frequency was similar in GP-Lis25 and Ly-Lis25 groups both at week 12 (p = 0.651) and 26 (p = 0.164). The difference of HbA1c change at week 26 was (95% CI) 0.01 (-0.27–0.28)%. Fasting plasma glucose, seven-point glucose profile and insulin dose were similar between groups. Safety did not differ between groups. Conclusion: GP-Lis25 and Ly-Lis25 demonstrated similar safety and efficacy. ClincalTrials.gov identifier: NCT04023344 .


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