Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Adhikari Neill Kj, Pinto Ruxandra, Day Andrew G, Masse Marie-Hélène, Ménard Julie, Sprague Sheila, Annane Djillali, Arabi Yaseen M, Battista Marie-Claude, Cohen Dian, Cook Deborah J, Guyatt Gordon H, Heyland Daren K, Kanji Salmaan, McGuinness Shay P, Parke Rachael L, Tirupakuzhi Vijayaraghavan Bharath Kumar, Charbonney Emmanuel, Chassé Michaël, Del Sorbo Lorenzo, Kutsogiannis Demetrios James, Lauzier François, Leblanc Rémi, Maslove David M, Mehta Sangeeta, Mekontso Dessap Armand, Mele Tina S, Rochwerg Bram, Rewa Oleksa G, Shahin Jason, Twardowski Pawel, Young Paul Jeffrey, Lamontagne François, LOVIT Investigators
Аннотация
OBJECTIVE: We aim to describe a prespecified statistical analysis plan (SAP) for the LOVIT trial prior to unblinding and locking of the trial database.
METHODS: The SAP was designed by the LOVIT principal investigators and statisticians, and approved by the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes, and describes the planned primary, secondary, and subgroup analyses.
RESULTS: The SAP includes a draft participant flow diagram, tables, and planned figures. The primary outcome is a composite of mortality and persistent organ dysfunction (receipt of mechanical ventilation, vasopressors, or new renal replacement therapy) at 28 days, where day 1 is the day of randomization. All analyses will use a frequentist statistical framework. The analysis of the primary outcome will estimate the risk ratio and 95% CI in a generalized linear mixed model with binomial distribution and log link, with site as a random effect. We will perform a secondary analysis adjusting for prespecified baseline clinical variables. Subgroup analyses will include age, sex, frailty, severity of illness, Sepsis-3 definition of septic shock, baseline ascorbic acid level, and COVID-19 status.
CONCLUSIONS: We have developed an SAP for the LOVIT trial and will adhere to it in the analysis phase.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36261.