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

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          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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          Most cited references36

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          A controlled trial of arthroscopic surgery for osteoarthritis of the knee.

          J Bruce Moseley, Kimberly O'malley, Nancy Petersen … (2002)
          Many patients report symptomatic relief after undergoing arthroscopy of the knee for osteoarthritis, but it is unclear how the procedure achieves this result. We conducted a randomized, placebo-controlled trial to evaluate the efficacy of arthroscopy for osteoarthritis of the knee. A total of 180 patients with osteoarthritis of the knee were randomly assigned to receive arthroscopic débridement, arthroscopic lavage, or placebo surgery. Patients in the placebo group received skin incisions and underwent a simulated débridement without insertion of the arthroscope. Patients and assessors of outcome were blinded to the treatment-group assignment. Outcomes were assessed at multiple points over a 24-month period with the use of five self-reported scores--three on scales for pain and two on scales for function--and one objective test of walking and stair climbing. A total of 165 patients completed the trial. At no point did either of the intervention groups report less pain or better function than the placebo group. For example, mean (+/-SD) scores on the Knee-Specific Pain Scale (range, 0 to 100, with higher scores indicating more severe pain) were similar in the placebo, lavage, and débridement groups: 48.9+/-21.9, 54.8+/-19.8, and 51.7+/-22.4, respectively, at one year (P=0.14 for the comparison between placebo and lavage; P=0.51 for the comparison between placebo and débridement) and 51.6+/-23.7, 53.7+/-23.7, and 51.4+/-23.2, respectively, at two years (P=0.64 and P=0.96, respectively). Furthermore, the 95 percent confidence intervals for the differences between the placebo group and the intervention groups exclude any clinically meaningful difference. In this controlled trial involving patients with osteoarthritis of the knee, the outcomes after arthroscopic lavage or arthroscopic débridement were no better than those after a placebo procedure.
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            Challenges in evaluating surgical innovation.

            Patrick Ergina, Jonathan A Cook, Jane Blazeby … (2009)
            Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.
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              Randomised trials in surgery: problems and possible solutions.

              Damian Griffin, Paris B. Lovett, Mitsuru Sasako … (2002)
              Article 0 comments Cited 165 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Jonathan A Cook: Role: methodologist
                Peter McCulloch: Role: clinical reader in surgery
                Jane M Blazeby: Role: professor of surgery
                David J Beard: Role: professor of musculoskeletal sciences
                Danica Marinac-Dabic: Role: director
                Art Sedrakyan: Role: associate professor of public health and cardiac surgery
                Journal
                Journal ID (nlm-ta): BMJ
                Journal ID (iso-abbrev): BMJ
                Journal ID (publisher-id): bmj
                Title: BMJ : British Medical Journal
                Publisher: BMJ Publishing Group Ltd.
                ISSN (Print): 0959-8138
                ISSN (Electronic): 1756-1833
                Publication date Collection: 2013
                Publication date (Print): 2013
                Publication date (Electronic): 18 June 2013
                Volume: 346
                Electronic Location Identifier: f2820
                Affiliations
                [1 ]Health Services Research Unit, University of Aberdeen, Aberdeen AB25 2ZD, UK
                [2 ]Nuffield Department of Surgical Science, University of Oxford, Oxford, UK
                [3 ]Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, UK
                [4 ]Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
                [5 ]National Institute for Health Research Oxford Musculoskeletal Biomedical Research Unit, Oxford, UK
                [6 ]Division of Epidemiology, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, MD, USA
                [7 ]Weill Cornell Medical College of Cornell University and New York Presbyterian Hospital, New York, NY, USA
                Author notes
                Correspondence to: J A Cook j.a.cook@ 123456abdn.ac.uk
                Article
                Publisher ID: cooj009972
                DOI: 10.1136/bmj.f2820
                PMC ID: 3685513
                PubMed ID: 23778425
                SO-VID: f9d0393b-7d3d-4ca7-8ccb-b2622e82d75f
                Copyright © © Cook et al 2013
                License:

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.

                History
                Date accepted : 15 March 2013
                Related
                Research Methods & Reporting, doi:10.1136/bmj.f3012Research Methods & Reporting, doi:10.1136/bmj.f3011
                Categories
                Subject: Research Methods & Reporting

                ScienceOpen disciplines: Medicine
                Data availability:
                ScienceOpen disciplines: Medicine

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