Elsevier

The Lancet

Volume 374, Issue 9695, 26 September–2 October 2009, Pages 1089-1096
The Lancet

Series
Evaluation and stages of surgical innovations

https://doi.org/10.1016/S0140-6736(09)61083-7Get rights and content

Summary

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.

Introduction

During the past 30 years, modern surgical care has greatly improved patients' quality and length of life.1 These advances have been usually related to clinical manoeuvres that applied clear-cut pathophysiological and anatomical concepts. Occasionally, however, the premise might have been dubious as, for example, in the case of total colon resection to treat female autointoxication.2 Irrespective of the scientific basis for the proposed innovation, the usefulness of the intervention has usually been clinically obvious—eg, cessation of bleeding, closure of a perforated viscus, repair of a shattered bone, and excision of an abnormal growth. In the most common clinical setting, surgical progress has been a process of trial and error. Formal and comparative assessment of procedures had little role, and only scant attention had been paid to patient and societal inconvenience or cost.

Because patient outcomes have improved and proof of superior effectiveness has become more challenging than in the past, surgeons have now adopted a more scientific basis to change strategies in patient care, turning to the current medical standard for the development of knowledge—evidence-based health care.3

Evidence-based health care is characterised by the promotion of unbiased, highly reliable types of evidence (eg, randomised controlled trials, although other forms of evidence are possible).4, 5, 6 Despite the endorsement of evidence-based health care by the surgical community, reviews of surgical reports show a substantial under-representation of randomised controlled trials.7, 8 In addition to the paucity of randomised controlled trials, the few published controlled surgical trials do not meet current quality standards for optimal reporting.9, 10

Several attempts to address these shortcomings have appeared in surgical reports over recent years, but there has been little evidence of sustained success.11, 12, 13 Indeed, the frequency of surgical randomised controlled trials has remained low: 9% in 1993 and 8% in 2006.7, 12, 14 Although surgeons are not alone in rarely using randomised designs,15, 16, 17 formal assessment might be less feasible in surgery than in other medical domains.18, 19, 20 Possible reasons include the types of patients in surgery, the complexity of surgical interventions, and the disposition of surgeons. One other factor that complicates any assessment is the constant innovation of surgery. Indeed, innovation is at the core of both surgical practice and research, as illustrated by the statement of the American Society of University Surgeons, “surgeons are trained to perform continuous situational assessment, decision analysis, and improvisation, in preparation for the challenges and creativity required by nearly every clinical case”.21

In this report, we examine some of the processes of innovation and assessment of a surgical intervention or operation. Conventionally defined as a medical procedure involving an incision with instrument, Krummel22 proposed that an operation consists of two components: the first is imaging (visual or other [eg, radiological]) and the second is a manipulation (manual or through a source of energy or shockwave).

In the second paper of this Series,23 we focus on methodological problems to the best possible assessment of surgery, and in the third paper24 we propose a paradigm to deal with the timely and appropriate assessment of surgical innovation along its different stages. Many of our conclusions will not only be true for innovative procedures in surgery, but will also be applicable to other intervention-based or craft-based specialties such as cardiology, radiology, or gastroenterology.

Section snippets

Innovation and surgery

In surgery, many definitions and nomenclatures describe the process of innovation and the innovations themselves.25, 26, 27 An innovative procedure in surgery has been described as “a new or modified surgical procedure that differs from currently accepted local practice, the outcomes of which have not been described, and which may entail risk to the patient”.21 Because not all innovations are equal, a three-level taxonomy of innovation in surgical care has been proposed, which ranges from

Surgery and harms to patients

Surgeons pay attention to patient harms, perhaps even before efficacy or effectiveness, to assess quality of patient care. Early efforts can be credited to Ernest A Codman, a surgeon in the late 1890s and a founder of the American College of Surgeons.43 His peers ostracised him for his interest in using surgical outcomes to improve surgical care, which led to the revocation of his privileges from the Massachusetts General Hospital in 1914.44 Over 90 years later, in a review of 276 surgical

Adoption of surgical innovation

Adoption of an innovation into practice can be defined by the increase in the number of overall surgeons doing the procedure over time, which will occur until it is either accepted by surgeons or discarded. One paradigm of diffusion of an innovation is sociological. Rogers54 has commented on an S-curve model to describe the adoption of an agricultural innovation (a new type of corn) by a large community of farmers. The curve was descriptive, independent of a regulatory context, and not only

Stages of surgical innovation

To describe and assess the development of a new surgical innovation, a more useful model is to segment it into sequential stages that are most characteristic of the early events of adoption (table 2). These stages can be defined not only by the development of the innovation but also by the unique opportunity for critical appraisal that each represents. These stage-specific features are based on the following characteristics: level of refinement of the new technique (ie, is there still a

Conclusions

We have focused on the intricate relation between innovation and practice in surgery, and how this needs a formalised evaluative framework. The application of this paradigm of staged development and evaluation is further discussed in the third paper of this Series.24 The second paper of this Series23 describes methodological challenges to the evaluation of surgical innovation.

Glossary

Augmented reality
is a recent technology that is similar to the virtual reality paradigm. It combines three-dimensional computer-generated objects and text superimposed, and it allows the creation of a hybrid, virtual patient model based on information from multiple imaging sources

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