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. 2013 Jun 18:346:f2820.
doi: 10.1136/bmj.f2820.

IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage

Jonathan A Cook  1 , Peter McCulloch, Jane M Blazeby, David J Beard, Danica Marinac-Dabic, Art Sedrakyan; IDEAL Group
Collaborators, Affiliations

IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage

Jonathan A Cook et al. BMJ. .

Abstract

The complexity of surgical procedures often poses challenges for conducting a rigorous and comprehensive evaluation. This paper considers the final two IDEAL stages of surgical innovation. Surgical randomised controlled trials are often challenging to undertake and require careful consideration of the intervention definition, who should deliver it, and the impact of surgeon and patient preferences. In the long term study stage, better monitoring of surgical procedures is needed, along with improved surveillance of devices.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: PM received financial support from the National Institute for Health Research’s Health Technology Assessment programme, Johnson & Johnson, Medtronic, and Zimmer for the IDEAL collaboration and for a workshop; DB has undertaken consultancy for ICNet and Stryker European Medicines Agency, and has received research grant funding from Genzyme; no other financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Use of the abdominal route (versus thoracic route) as a proportion of operations in hiatal hernia repair, by hospital. Data taken from US hospitals in the Nationwide Inpatient Sample; figure shows 708 hospitals (900 hospitals with 100% abdominal route use not shown). Blue=percentage of operations with abdominal route; black=95% exact (binomial) confidence intervals. Use of the abdominal route varied from 0% to 100% across hospitals
See this image and copyright information in PMC

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