کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5121853 1486845 2017 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Reducing sample size by combining superiority and non-inferiority for two primary endpoints in the Social Fitness study
ترجمه فارسی عنوان
کاهش میزان نمونه با ترکیب برتر و عدم پایین آمدن برای دو نقطه پایانی اولیه در مطالعه تناسب اندام
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی سیاست های بهداشت و سلامت عمومی
چکیده انگلیسی

ObjectivesIn randomized controlled trials, two endpoints may be necessary to capture the multidimensional concept of the intervention and the objectives of the study adequately. We show how to calculate sample size when defining success of a trial by combinations of superiority and/or non-inferiority aims for the endpoints.Study Design and SettingThe randomized controlled trial design of the Social Fitness study uses two primary endpoints, which can be combined into five different scenarios for defining success of the trial. We show how to calculate power and sample size for each scenario and compare these for different settings of power of each endpoint and correlation between them.ResultsCompared to a single primary endpoint, using two primary endpoints often gives more power when success is defined as: improvement in one of the two endpoints and no deterioration in the other. This also gives better power than when success is defined as: improvement in one prespecified endpoint and no deterioration in the remaining endpoint.ConclusionWhen two primary endpoints are equally important, but a positive effect in both simultaneously is not per se required, the objective of having one superior and the other (at least) non-inferior could make sense and reduce sample size.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Clinical Epidemiology - Volume 81, January 2017, Pages 86-95
نویسندگان
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