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Response to a pilot single‐centre randomized trial: the PATRASTOM trial
Author(s) -
Murkin C.,
Blazeby J. M.,
Blencowe N. S.,
Rooshenas L.,
Reeves B.,
Daniels I.,
Pinkney T.,
Smart N.
Publication year - 2016
Publication title -
colorectal disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.029
H-Index - 89
eISSN - 1463-1318
pISSN - 1462-8910
DOI - 10.1111/codi.13338
Subject(s) - medicine , research centre , randomized controlled trial , family medicine , library science , surgery , computer science
We read the PATRASTOM pilot randomised controlled trial (RCT) paper (1) with great interest. Parastomal Hernia (PSH) prevention is an area needing high quality evidence. Good pre-trial work, such as pilot studies, has an important role in the design of definitive multi-centre trials. We have several methodological concerns, however, that limit the findings and interpretation of this study. Pilot studies aim to test the feasibility, reliability and validity of the proposed design of a main RCT [2]. As such, pilot RCTs are designed to establish whether, for example, it is possible to recruit and randomise patients, and whether the preferred end points in a main trial can be collected with acceptable completeness [3]. This article is protected by copyright. All rights reserved