التفاصيل البيبلوغرافية
| العنوان: |
Methods for Specifying the Target Difference in a Randomised Controlled Trial: The Difference ELicitation in TriAls (DELTA) Systematic Review |
| المؤلفون: |
Jenni Hislop, Temitope E Adewuyi, Luke D Vale, Kirsten Harrild, Cynthia Fraser, Tara Gurung, Douglas G Altman, Andrew H Briggs, Peter Fayers, Craig R Ramsay, John D Norrie, Ian M Harvey, B |
| المصدر: |
Public Library of Science, PLOS Medicine. 11(5):1-16 |
| سنة النشر: |
2014 |
| الوصف: |
Jonathan Cook and colleagues systematically reviewed the literature for methods of determining the target difference for use in calculating the necessary sample size for clinical trials, and discuss which methods are best for various types of trials. Background: Randomised controlled trials (RCTs) are widely accepted as the preferred study design for evaluating healthcare interventions. When the sample size is determined, a (target) difference is typically specified that the RCT is designed to detect. This provides reassurance that the study will be informative, i.e., should such a difference exist, it is likely to be detected with the required statistical precision. The aim of this review was to identify potential methods for specifying the target difference in an RCT sample size calculation. Methods and Findings: A comprehensive systematic review of medical and non-medical literature was carried out for methods that could be used to specify the target difference for an RCT sample size calculation. The databases searched were MEDLINE, MEDLINE In-Process, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Methodology Register, PsycINFO, Science Citation Index, EconLit, the Education Resources Information Center (ERIC), and Scopus (for in-press publications); the search period was from 1966 or the earliest date covered, to between November 2010 and January 2011. Additionally, textbooks addressing the methodology of clinical trials and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) tripartite guidelines for clinical trials were also consulted. A narrative synthesis of methods was produced. Studies that described a method that could be used for specifying an important and/or realistic difference were included. The search identified 11,485 potentially relevant articles from the databases searched. Of these, 1,434 were selected for full-text assessment, and a further nine |
| نوع الوثيقة: |
redif-article |
| اللغة: |
English |
| DOI: |
10.1371/journal.pmed.1001 |
| الإتاحة: |
https://ideas.repec.org/a/plo/pmed00/1001645.html |
| رقم الأكسشن: |
edsrep.a.plo.pmed00.1001645 |
| قاعدة البيانات: |
RePEc |
