Common use of Proposed sample size/Power calculations Clause in Contracts

Proposed sample size/Power calculations. The literature of MFR is scarce and information on the primary endpoint “time to full enteral feeds” is limited [4]. A recently published retrospective analysis of 24 patients [3] of which 13 received refeeding of stool to the mucus fistula and 11 did not receive refeeding of stool showed a median time from reanastomosis to enteral feeds of 7 days in the control group and 4 days in the refeeding group. The data presented for the control group is in line with retrospective data of 42 patients collected at Hannover Medical School. These 42 patients are all patients fulfilling the inclusion criteria who were treated at Hannover Medical School between 2005 and 2015. They did not receive refeeding of stool and had a median time to full enteral feeds of 7 days. According to Xxxxx et al. [3] a survival analysis is appropriate. In their respective publication, median times are reported corresponding to a hazard ratio of 1.751 for time to enteral feeds (4 days vs 7 days), 2.331 for parenteral nutrition discontinuation (6 days vs 14 days) and 2.667 for goal feeds (7.5 days vs 20 days). Because time to enteral feeds in this publication is in line with our retrospective data of time to full feeds, a hazard ratio of 1.751 is assumed for the treatment effect. In order to show a treatment effect with a power of 80% and a two-sided type I error probability of 5 % with a logrank test a total of 100 events (full enteral feeds) is required, if the hazard ratio for the treatment effect is 1.751. Since patients will be in neonatal intensive care, every patient is expected to reach full enteral feeds. Nonetheless, to account for possible deaths, the sample size was increased by 6 patients, resulting in a total of 106 patients. Sample size was estimated in nQuery Advisor 7.

Proposed sample size/Power calculations. The literature of MFR is scarce and information on the primary endpoint “time to full enteral feeds” is limited [4]. A recently published retrospective analysis of 24 patients [3] of which 13 received refeeding of stool to the mucus fistula and 11 did not receive refeeding of stool showed a median time from reanastomosis enterostomy takedown to enteral feeds of 7 days in the control group and 4 days in the refeeding group. The data presented for the control group is in line with retrospective data of 42 patients collected at Hannover Medical School. These 42 patients are all patients fulfilling the inclusion criteria who were treated at Hannover Medical School between 2005 and 2015. They did not receive refeeding of stool and had a median time to full enteral feeds of 7 days. According to Xxxxx et al. [3] a survival analysis is appropriate. In their respective publication, median times are reported corresponding to a hazard ratio of 1.751 for time to enteral feeds (4 days vs 7 days), 2.331 for parenteral nutrition discontinuation (6 days vs 14 days) and 2.667 for goal feeds (7.5 days vs 20 days). Because time to enteral feeds in this publication is in line with our retrospective data of time to full feeds, a hazard ratio of 1.751 is assumed for the treatment effect. In order to show a treatment effect with a power of 80% and a two-sided type I error probability of 5 % with a logrank test a total of 100 events (full enteral feeds) is required, if the hazard ratio for the treatment effect is 1.751. Since patients will be in neonatal intensive care, every patient is expected to reach full enteral feeds. Nonetheless, to account for possible deathsdeaths and patients that are not able to reach full enteral feeds or abide the study protocol, the sample size was increased by 6 20 patients, resulting in a total of 106 120 patients. Sample size was estimated in nQuery Advisor 7.

Proposed sample size/Power calculations. ‌ The literature of MFR is scarce and information on the primary endpoint “time to full enteral feeds” is limited [4]. A recently published retrospective analysis of 24 patients [3] of which 13 received refeeding of stool to the mucus fistula and 11 did not receive refeeding of stool showed a median time from reanastomosis to enteral feeds of 7 days in the control group and 4 days in the refeeding group. The data presented for the control group is in line with retrospective data of 42 patients collected at Hannover Medical School. These 42 patients are all patients fulfilling the inclusion criteria who were treated at Hannover Medical School between 2005 and 2015. They did not receive refeeding of stool and had a median time to full enteral feeds of 7 days. According to Xxxxx et al. [3] a survival analysis is appropriate. In their respective publication, median times are reported corresponding to a hazard ratio of 1.751 for time to enteral feeds (4 days vs 7 days), 2.331 for parenteral nutrition discontinuation (6 days vs 14 days) and 2.667 for goal feeds (7.5 days vs 20 days). Because time to enteral feeds in this publication is in line with our retrospective data of time to full feeds, a hazard ratio of 1.751 is assumed for the treatment effect. In order to show a treatment effect with a power of 80% and a two-sided type I error probability of 5 % with a logrank test a total of 100 events (full enteral feeds) is required, if the hazard ratio for the treatment effect is 1.751. Since patients will be in neonatal intensive care, every patient is expected to reach full enteral feeds. Nonetheless, to account for possible deaths, the sample size was increased by 6 patients, resulting in a total of 106 patients. Sample size was estimated in nQuery Advisor 7.