Intended for healthcare professionals

Rapid response to:

Research Methods & Reporting

Rethinking pragmatic randomised controlled trials: introducing the “cohort multiple randomised controlled trial” design

BMJ 2010; 340 doi: (Published 19 March 2010) Cite this as: BMJ 2010;340:c1066

Rapid Response:

Patient benefits in the cmRCT design

The cohort multiple randomised controlled design paper is a
fascinating read, presenting a concise run-through of limitations in RCT
design and the relationship of the cmRCT to its forerunners, the
randomised consent and patient preference designs.
Although the authors are thorough in their presentation of the
methodological limitations and challenges of the cmRCT (such as
researching interventions already freely available) the ethical challenges
of this design are given less attention. The assertion that it is of
‘patient benefit’ to not be told about treatment you may not receive or
that it will be allocated by chance is not a foregone conclusion, and can
perhaps be more strongly contended in the context of a research study in
which participant benefit ( or certainly absence of harm and the exercise
of free will) is of more direct concern. In essence, withholding
information about treatment options and methods of allocation is a well-
intentioned strategy to improve generalisability of findings by
replicating a ‘real world’ treatment scenario in which the patient is not
a participant. But this poses a question- to what degree can a study
design ‘ignore’ the difference between these two roles whilst addressing
the specific ethical concerns of research participation? The distinctions
between ‘participant’ and ‘patient’ are ethically as well as
methodologically relevant to research design, particularly in the
development of exciting innovations such as the cmRCT.

Competing interests:
None declared

Competing interests: No competing interests

21 April 2010
Natalie L Lambert
Senior Research Fellow
University of Brighton, UK, BN1 9PH