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

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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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Most cited references 28

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The International Registry of Acute Aortic Dissection (IRAD): new insights into an old disease.

P. Hagan, C. A. Nienaber, E. Isselbacher … (2000)

Acute aortic dissection is a life-threatening medical emergency associated with high rates of morbidity and mortality. Data are limited regarding the effect of recent imaging and therapeutic advances on patient care and outcomes in this setting. To assess the presentation, management, and outcomes of acute aortic dissection. Case series with patients enrolled between January 1996 and December 1998. Data were collected at presentation and by physician review of hospital records. The International Registry of Acute Aortic Dissection, consisting of 12 international referral centers. A total of 464 patients (mean age, 63 years; 65.3% male), 62.3% of whom had type A dissection. Presenting history, physical findings, management, and mortality, as assessed by history and physician review of hospital records. While sudden onset of severe sharp pain was the single most common presenting complaint, the clinical presentation was diverse. Classic physical findings such as aortic regurgitation and pulse deficit were noted in only 31.6% and 15.1% of patients, respectively, and initial chest radiograph and electrocardiogram were frequently not helpful (no abnormalities were noted in 12.4% and 31.3% of patients, respectively). Computed tomography was the initial imaging modality used in 61.1%. Overall in-hospital mortality was 27.4%. Mortality of patients with type A dissection managed surgically was 26%; among those not receiving surgery (typically because of advanced age and comorbidity), mortality was 58%. Mortality of patients with type B dissection treated medically was 10.7%. Surgery was performed in 20% of patients with type B dissection; mortality in this group was 31.4%. Acute aortic dissection presents with a wide range of manifestations, and classic findings are often absent. A high clinical index of suspicion is necessary. Despite recent advances, in-hospital mortality rates remain high. Our data support the need for continued improvement in prevention, diagnosis, and management of acute aortic dissection.

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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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Evaluation and stages of surgical innovations.

Jeffrey Barkun, Jeffrey Aronson, Liane Feldman … (2009)

Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.

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Author and article information

Contributors

Patrick L Ergina: Role: assistant professor of surgery

Jeffrey S Barkun: Role: professor of surgery

Peter McCulloch: Role: clinical reader in surgery

Jonathan A Cook: Role: methodologist

Douglas G Altman: Role: director

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: f3011

Affiliations

[1 ]Cardiothoracic Surgery Division, McGill University Health Centre, Royal Victoria Hospital, Montreal, Quebec, Canada H3A 1A1

[2 ]Oxford International Programme in Evidence-Based Health Care, University of Oxford, Oxford, UK

[3 ]Department of Surgery, McGill University, Montreal, Canada

[4 ]Nuffield Department of Surgical Science, University of Oxford, UK

[5 ]Health Services Research Unit, University of Aberdeen, Aberdeen, UK

[6 ]Centre for Statistics in Medicine, University of Oxford, UK

Author notes

Correspondence to: P L Ergina patrick.ergina@ 123456muhc.mcgill.ca

Article

Publisher ID: ergp009973

DOI: 10.1136/bmj.f3011

PMC ID: 3685514

PubMed ID: 23778426

SO-VID: 2b111d50-7862-4e16-b988-47d72b851f66

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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/.

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

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Most cited references 28

The International Registry of Acute Aortic Dissection (IRAD): new insights into an old disease.

Challenges in evaluating surgical innovation.

Evaluation and stages of surgical innovations.

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