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. 2013 Jun 18:346:f3011.
doi: 10.1136/bmj.f3011.

IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages

Patrick L Ergina  1 , Jeffrey S Barkun, Peter McCulloch, Jonathan A Cook, Douglas G Altman; IDEAL Group
Collaborators, Affiliations

IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages

Patrick L Ergina et al. BMJ. .

Abstract

The IDEAL framework describes the stages of evaluation for surgical innovations. This paper considers the role of observational studies in the exploration and assessment stages. At the exploration stage, the surgical intervention is usually more widely used, and observational studies should collect prospective data from multiple surgeons, deal with factors such as case mix and learning, and prepare for a definitive evaluation at the next stage of assessment. Although a randomised controlled trial is preferable, a high quality observational study would be acceptable if a randomised trial is not feasible or, on rare occasions, deemed unnecessary.

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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; 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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Fig 1 Theoretical adoption curve showing the different stages (according to adopter type) in the diffusion of a surgical innovation
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Fig 2 Example of surgical innovation: laparoscopic procedure adoption. Reproduced from reference 8 with permission. Data are percentage of operations carried out using a laparoscopic approach in 1989-2003, from the Nationwide Inpatient Sample, a nationally representative annual sample of hospital admissions in the United States
See this image and copyright information in PMC

References

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    1. McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009;374:1105-12. - PubMed
    1. McCulloch P, Cook JA, Altman DG, Heneghan C, Diener MK. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ 2013;346:f3012. - PMC - PubMed
    1. Cook JA, McCulloch P, Blazeby JM, Beard DJ, Marinac-Dabic D, Sedrakyan A. IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. BMJ 2013;346:f2820. - PMC - PubMed
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