‘Buxton’s law’ of investigation of a surgical innovation states: ‘…it is always too early for rigorous evaluation until, unfortunately, it’s suddenly too late.’1 Adoption of new surgical techniques in gynaecology is vital for the improved care of our patients and the development of the profession. A pivotal positive example is the revolution of gynaecological care by laparoscopic surgery in the 1980s. New surgical procedures and devices can appear very attractive to surgeons and patients alike. However, the diffusion of surgical innovations into common practice raises serious questions about patient safety.
Firstly, how should we decide which techniques to adopt to maximise patient benefit over existing surgical procedures? The insinuation into surgical care of new techniques because they are presumed to offer better care lays the basis for the mistaken belief that randomised controlled trials are unethical in many areas of surgery. This has led to procedures being introduced that are offered to the wrong patient population, are ineffective or inferior to established techniques, may waste resources or even endanger lives.2 Secondly, how can new surgical techniques be safely integrated into current surgical practice to minimise risks to patient safety? A regulatory framework is desirable to protect patients.
Drivers for change
An innovative procedure in surgery can be defined 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’.3 There are two types of surgical innovation to consider in gynaecology: either a new procedure that uses existing devices or drugs (for example, morcellation of fibroids, progesterone-secreting IUDs) or an existing procedure that uses new devices (such as the use of transvaginal polypropylene mesh in prolapse surgery).
Wilson4 has described the factors that determine acceptance of the new technique. They may relate to the ‘intrinsic characteristics’ of the technology or the contextual factors that ‘promote’ the technique. It is noteworthy that only some of them are amenable to any formal scientific assessment or evidence-based healthcare evaluation.
Factors determining the adoption of technology by surgeons and patients:
- operating facilities are available to easily adopt the technique into current practice;
- surgeons have an opportunity to observe the new technique;
- procedure can be offered for a trial period before full adoption;
- procedure is a ‘simple modification’ or easily learned;
- expected demand from patients justifies surgeons learning the procedure
- procedure appeals to patients/ patients demand the procedure;low cost to surgeons of learning and using the procedure;
- aggressive promotion of the technology by the manufacturer; and
- magnitude of benefit perceived by each ‘stakeholder’– doctors, patients, hospitals.
Models for assessing innovation
Adoption of a new surgical technique has traditionally been viewed using a sociological model, assessing the number of surgeons who gradually embrace the procedure until it has become either accepted as standard care or is discarded.
According to Rogers5, a social theorist, the diffusion of new technologies is initially launched by ‘innovators’ who are willing to take risks. The innovators are followed by the ‘early adopters’ (who are often opinion leaders in the industry with significant clout); then the ‘early majority’, the ‘late majority’ and finally the ‘laggards’. There is a tipping point, at 10–20 per cent, whereby diffusion into the industry increases exponentially. The risks of patient harm are likely to be greatest as the innovation nears the tipping point. This is the stage at which the procedure diffuses from early expert adopters/opinion leaders to the early majority in the general surgical community. At this point, it appears vital that a hospital develops standardised training and credentialing for surgical teams. An analogy has been drawn with the aviation industry, which retrains flight crews who are inexperienced in new types of aircraft.6
Buxton described the introduction of a new procedure into standard practice according to our ability to assess it.1 Initially, when a small number of surgeons are adopting a procedure, we have the opportunity to research it. However, since the procedure is still on a learning curve and technically immature, there is an inherent methodological flaw in analysis of its utility. Soon after, the technology can be very quickly embraced and the tipping point crossed. Once the procedure is adopted by a large number of operators, formal assessment is no longer feasible and we have lost the opportunity to comprehensively evaluate it.
Using scientific principles
The Balliol Collaboration (University of Oxford) has published their approach to the stages of surgical innovation, based on the scientific principles of evidence-based healthcare.7
Stage 0 and stage 1: innovation
Stage 0 refers to prehuman/animal development and stage 1 is where the procedure is first used on humans. This stage hopes to establish acceptable levels of safety and proof of concept. Patient safety can be improved through the use of simulators.
The nature of the disease and proven alternative treatments determine the success of this stage. For example, in liver transplantation there was no alternative to end-stage disease and the balance between patient safety and possible benefit allowed greater surgical risk. Formal patient consent can be problematic as many risks are unknown.
Stage 2a: development
In Stage 2a the early surgical innovators deem the procedure to be safe, but are still experimenting with technical details of the operation and equipment. The surgical technique disseminates to ‘opinion leaders’ with high credibility who are influential in determining the success and further diffusion of the technique.
This is the most important time to research the procedure and attempts should be made to replicate early studies. Few patients are recruited and the innovative surgeons are highly selective for particular characteristics. The selected patients tend to be healthier, younger and better educated.8 This may skew any studies assessing patient safety. A recent report in the BMJ addressed this issue when the rapid uptake of minimally invasive radical prostatectomy initially suggested statistically significant lower risks on all patient safety indicators over open prostatectomy. However, when adjusted for patient characteristic variables (white, healthier, better off), the association was not significant.9
Stage 2b: early dispersion and exploration
In Stage 2b the learning curves of the surgeons – particularly the innovators – are progressing rapidly. The indications for the surgery are becoming broader and the surgery is more efficient, with shorter operating times. The safety of the novel procedure is becoming established as well as its comparison to established techniques.
Hospitals and individuals wishing to have a competitive edge will embrace the new technique. Regulatory frameworks for accreditation need to be established, but there is little possibility of assessment of long-term harms.
Stage 3: assessment
Many surgeons are now competent in the procedure and the tipping point has been passed. The innovation has become the established standard of care and few surgeons have not learned or adopted the technique. Opportunities for formalised assessment no longer exist and, for better or worse, the procedure has been embraced. Patient selection criteria for the procedure have been determined. Patient consent falls into the established clinical care guidelines rather than the special considerations to be given to experimental procedures. Patients are now generally aware of the availability of the procedure and are demanding it.
Stage 4: long-term implementation and monitoring
This stage concerns the use of the established procedure in surgical training of juniors and long-term monitoring for rare complications.
Implementation to minimise errors
Just like any systemic change within healthcare, implementation of a new technique must have prior assessment and planning. There are many resources available to guide healthcare professionals and organisations through this process, including the Royal Australian College of Surgeons New and Emerging Techniques – Surgical (NET-S)10, the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S)11 and the overarching National Safety and Quality Health Service (NSQHS) Standards.12 In particular, attention must be paid to preventing and controlling healthcare-associated infections, patient identification and procedure matching, clinical handover (including use of a pre-procedure safety checklist), preventing and managing pressure injuries and recognising and responding to clinical deterioration.
A structured, formalised process allows for identification of safety issues at the outset, implementation of risk-management principals and regular review during implementation. This protects the interests of patients, clinicians and the organisation.13 Any process change requires a baseline evaluation and, depending on the magnitude of the technique to be implemented, this may require the approval of an individual to perform the new technique or the assembly of a working group to evaluate widespread implementation, or something in between. Considerations prior to implementation include surgical and safety principles, the evidence for the new technique and the plan for enactment.
What is the purpose or indication for the new technique? Is it applicable to the population serviced by the organisation? Importantly, a cost and benefit analysis should be performed. Are there improved outcomes for the patient? Is there a reduction in hospital stay with conferred clinical and economic benefits? Are the consumables less expensive? Is there a short-term economic cost, but long-term benefit to the health service?
It is imperative to determine what is known already about the proposed procedure. What clinical evaluation has been performed for the technique previously and does the evidence suggest it is efficacious? If so, is it applicable to the local conditions and patient population? To assist in answering these questions, ASERNIP-S provides access to full and systematic reviews, ‘horizon scanning’ for new techniques and the establishment and facilitation of clinical and research audits or studies.14 Evidence should be reviewed during the planning stage (ideally systematic review and meta-analysis, but including controlled clinical trials and case reports), to flag any potential safety concerns, and/or lessons learned from other organisations that have implemented the technique previously.
One must assess what the training requirements are and estimate the impact of the learning curve13: individual, team (operative and non-operative) and organisational. Are there ways to minimise the impact on other patients caused by the redirection of personnel and service allocation? The opportunity to use preceptors and senior clinicians skilled in the new technique is invaluable and should be seized whenever possible.
Essential to the process are robust clinical governance policies, including a pathway for surgeon approval, credentialing and review of ethical issues. If the new technique also includes a new technology or device, has TGA approval been granted?
Consumer engagement and patient informed consent is integral to the successful and safe implementation of a new technique.15 Patients must be informed that the technique is new and/or experimental. As much as possible, they should be given information regarding expected clinical outcomes/benefit, acknowledgement of medical uncertainty (owing to the infancy of the procedure) and information regarding the safety mechanisms in place.
If the technique is being implemented in the form of a clinical trial, ethics approval should be obtained with a robust process for reporting adverse events. If outside a trial, regular clinical audit should be performed and, additionally, any problems with medical devices should be reported to the TGA as part of the Australian and New Zealand Medical Device Incident Report Investigation Scheme.16
A vigorous clinical evaluation should be performed to assess the short- and long-term outcomes. This should include clinical, economic, training and organisational outcomes, with longevity relevant to the technique involved. If the technique is deemed successful, and thus adopted into routine clinical practice, further assessment should be performed regularly and results should be promoted and/or published in order to facilitate the implementation of the technique in other health services. A significant volume of data for innovation, in particular unsuccessful endeavours, is not currently recorded, leading to the proving of an innovation’s failure to be repeated time and again.17 18 Review at the health-service level should determine whether a critical volume of procedures using the new technique are being performed in order to maintain the necessary skillset.
Innovation in surgical practice should be actively encouraged, to foster improved clinical outcomes, without compromising patient, clinician or organisational safety, and with robust mechanisms for monitoring the efficacy and safety of new interventions.
While acknowledging the methodological challenges in the evaluation of surgical innovation, solid evidence is needed before formal implementation of new surgical techniques should begin. As Wilson so poignantly noted, ‘in the final analysis, a surgeon’s skill and ability to perform a procedure well is unimportant, in fact irrelevant, if the procedure should not be done in the first place.’19