The comprehensive cohort model in a pilot trial in orthopaedic trauma
Kearney, Rebecca S., Achten, Juul, Parsons, Nicholas R. and Costa, Matthew L.. (2011) The comprehensive cohort model in a pilot trial in orthopaedic trauma. BMC Medical Research Methodology, Vol.11 (No.39). ISSN 1471-2288
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Official URL: http://dx.doi.org/10.1186/1471-2288-11-39
Background: The primary aim of this study was to provide an estimate of effect size for the functional outcome of
operative versus non-operative treatment for patients with an acute rupture of the Achilles tendon using
accelerated rehabilitation for both groups of patients. The secondary aim was to assess the use of a
comprehensive cohort research design (i.e. a parallel patient-preference group alongside a randomised group) in
improving the accuracy of this estimate within an orthopaedic trauma setting.
Methods: Pragmatic randomised controlled trial and comprehensive cohort study within a level 1 trauma centre.
Twenty randomised participants (10 operative and 10 non-operative) and 29 preference participants (3 operative
and 26 non-operative). The ge range was 22-72 years and 37 of the 52 patients were men. All participants had an
acute rupture of their Achilles tendon and no other injuries. All of the patients in the operative group had a simple
end-to-end repair of the tendon with no augmentation. Both groups then followed the same eight-week
immediate weight-bearing rehabilitation programme using an off-the-shelf orthotic. The disability rating index (DRI;
primary outcome), EQ-5D, Achilles Total Rupture Score and complications were assessed ed at two weeks, six
weeks, three months, six months and nine months after initial injury.
Results: At nine months, there was no significant difference in DRI between patients randomised to operative or
non-operative management. There was no difference in DRI between the randomised group and the parallel
patient preference group. The use of a comprehensive cohort of patients did not provide useful additional
information as to the treatment effect size because the majority of patients chose non-operative management.
Conclusions: Recruitment to clinical trials that compare operative and non-operative interventions is notoriously
difficult; especially within the trauma setting. Including a parallel patient preference group to create a
comprehensive cohort of patients has been suggested as a way of increasing the power of such trials. In our
study, the comprehensive cohort model doubled the number of patients involved in the study. However, a strong
preference for non-operative treatment meant that the increased number of patients did not significantly increase
the ability of the trial to detect a difference between the two interventions.
|Item Type:||Journal Article|
|Subjects:||R Medicine > R Medicine (General)
R Medicine > RD Surgery
|Divisions:||Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit
|Library of Congress Subject Headings (LCSH):||Achilles tendon -- Wounds and injuries -- Treatment, Clinical trials -- Methodology|
|Journal or Publication Title:||BMC Medical Research Methodology|
|Publisher:||BioMed Central Ltd.|
|Official Date:||5 April 2011|
|Access rights to Published version:||Open Access|
|Funder:||British Orthopaedic Association. Joint Action, Rosetrees Trust|
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