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Vol. 23 No 4 | Summer 2021
Women's Health
Introduction of new technology into practice
A/Prof Alan Lam
FRANZCOG FRCOG MB, BS (Hons)
Dr Alison Bryant-Smith
MBBS/BA, MPH, MSurgEd, MRCOG, FRANZCOG

During recent history, the practice of gynaecology has evolved at a rapid rate due to: the steady introduction of new technology; the provider’s eagerness to be at the cutting edge; and the consumer’s expectation that ‘new things are always better than old things’.1 However, unlike new medications, the adoption of new technology has remained largely unregulated, is often not subjected to the same rigorous scientific assessment and regulatory oversight, and may at times be spruiked by inventors who are key opinion leaders and manufacturers, with vested commercial interests.2 In this context, it is essential to recognise that neither healthcare providers nor consumers may fully understand the benefits and risks of new therapeutic options. Nonetheless, consumer safety remains the ethical and legal responsibility of the provider; hence, when embracing new technology, gynaecologists must be astute in differentiating between beneficial technological changes, and those that may cause harm.3

In this article, we will clarify the definition of ‘new technology’, and identify key considerations when deciding: whether and when to introduce a new technology into clinical practice; how to obtain informed consent around the proposed treatment; the potential benefits, material risks and consequences without adequate supporting evidence; and what should be done after adoption to ensure patient safety.4

Definition of new technology

In the medical context, ‘technology’ refers to a drug, device, procedure, technique, or process of care. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) considers ‘technology’ to be synonymous with devices, and ‘technique’ synonymous with procedures, and further sub-defines ‘new’ or ‘modified’ devices or procedures as follows:5

  • New device: product of disruptive innovation, or a device that has not been previously used by the surgeon (eg. the use of transvaginal synthetic mesh for prolapse repair).6
  • Modified device: existing device the surgeon has experience with, that has been altered to improve functionality or performance (eg. upgrade of an advanced energy device, which delivers increased sealing speed).7
  • New procedure: novel technique that differs dramatically from what the surgeon is used to, or a technique not previously used by the surgeon (eg. platelet rich plasma for stress urinary incontinence).8
  • Modified procedure: modification of a known procedure or technique, with which the surgeon is familiar (eg. vaginal natural orifice transluminal endoscopic surgery hysterectomy, instead of vaginal hysterectomy).9

Key questions

When considering introducing new technology into practice, clinicians should ask the following key questions:

Has the new technology been adequately tested for safety and efficacy?

Ideally, there should be robust data regarding safety, efficacy, and effectiveness of new technology before its introduction into clinical practice. However, evaluating new technology is a complex process for which there is no universal agreement regarding the evaluation pathways for generating and analysing data throughout its life cycle. Furthermore, objective assessment of a new technology is often complicated by clinical idiosyncrasies such as: procedural modifications by surgeons during development; lack of agreed outcomes; learning curves; variable training; variable operative capabilities; and patient and clinician treatment preferences. In addition, data from surgical trials may provide evidence suggesting short-term efficacy, yet fail to answer questions regarding long-term safety.10

A recent example is transvaginal mesh for the management of prolapse: early data suggested superior efficacy to native tissue repair, and led to its widespread adoption. Subsequent reports of mesh-related erosion and chronic pain led to medico-legal controversy, public enquiries, regulatory withdrawal, and manufacturer discontinuation of this once-promising technology from the pelvic floor surgical armamentarium.11

To help overcome the challenges in evaluating new technology, the Balliol Collaboration team proposed a five-stage process called ‘IDEAL’. Standing for Idea, Development, Exploration, Assessment, and Long-term study, the framework emphasises appropriate methods, data transparency, and the rigorous reporting of outcomes when evaluating new technology.12 It also recommends the widespread use of prospective databases, and anonymous reporting of adverse outcomes to professional registries. Despite gaining significant traction within academia, whether the IDEAL framework will be routinely adopted prior to the introduction of any new technology into clinical practice remains to be seen.13

Is the new technology as safe and effective as existing, proven techniques?

When adopting a new technology or technique, its safety and effectiveness must be compared to the existing gold standard. Consider the adoption of minimally invasive hysterectomy for benign pathology: the eVALuate study involved two parallel randomised trials, one comparing laparoscopic hysterectomy (LH) with abdominal hysterectomy, the other comparing LH with vaginal hysterectomy (VH).14 This landmark trial concluded that LH (when compared to abdominal hysterectomy) was associated with a significantly higher rate of major complications (lower urinary tract injury) and took longer to perform, yet was associated with less pain, quicker recovery, and better short-term quality of life. Taking these nuanced results into account, ACOG concluded that (when VH is not feasible) LH should be performed rather than abdominal hysterectomy.15

Regarding LH and malignant pathology: adding to earlier research supporting the safety of LH (over abdominal hysterectomy) for early-stage endometrial cancer,16 Uppal et al concluded that minimally invasive hysterectomy was superior to abdominal hysterectomy in the management of early cervical cancer.17 However, later research (the Laparoscopic Approach to Cervical Cancer [LACC] trial,18) concluded that laparoscopic radical hysterectomy was associated with worse disease-free and overall survival than an abdominal approach. Hence, the pendulum has swung back towards favouring the traditional open radical hysterectomy for women with early-stage cervical cancer.19

The above examples regarding the application of minimally invasive hysterectomy demonstrate the importance of high-quality clinical trials when comparing the safety and effectiveness of new technologies and their older counterparts.

Am I adequately qualified to offer the new technology?

Acquiring the appropriate skills is an absolute pre-requisite before using a new device or performing a new or modified surgical technique; additional criteria must also be met before a clinician can be considered fully qualified.5 Completing a comprehensive and well-designed educational program allows clinicians to: understand the relevant disease process(es); select suitable patients and pathologies to employ the new technology; and to recognise and manage any associated complications promptly. Preceptorship of initial cases often proves invaluable during the clinician’s early learning curve. In addition, an appropriate ongoing surgical caseload, an adequately trained surgical team, and systems to monitor outcomes and adverse events help practitioners to maintain competency when adopting the use of a new device or technique (eg. minimally invasive sacrocolpopexy).20

Is the new technology cost effective?

A cost-benefit analysis should be performed when considering the adoption of new technologies in comparison to established treatment options. Costs associated with a new technology may include the cost(s) of: the device/equipment; educating the clinician and surgical team; and maintenance and/or technical support. Potential cost-savings may include: shortened hospital stay; earlier resumption of work; and reduced healthcare costs in the long term. To monitor ongoing cost effectiveness, it would be necessary to establish and maintain a comparative database, in which outcome measures (including cost analyses) are routinely recorded.

The cost effectiveness of robotic technology in gynaecological surgery is a case in point. An early systematic review and meta-analysis concluded that robotic hysterectomy increased operative costs by 1.5- to 3-fold, with no improvement in any measurable clinical outcome.21 Another systematic review and meta-analysis found no statistically significant, nor clinically meaningful differences in surgical outcomes and a cost increase of $1607USD per robotic hysterectomy, if the initial cost outlay of buying the robotic device was gradually written off over its lifespan.22

What should be discussed with patients when a clinician is considering employing a new device or technique?

Patients must be informed of all relevant benefits and risks inherent to using a new technology.23 The exact information disclosed during the consent process depends upon what that particular patient considers to be a material risk. The 2020 NSW Consent to Medical and Healthcare Treatment Manual states that:

… the Health Practitioner must inform the patient that the procedure or treatment is new to their practice and provide the patient with details of their previous (potentially limited) experience with the procedure or treatment as part of the consent process.24

This detailed discussion should be documented in the patient’s health record, and should include (as relevant):

  • The potential benefits and risks of the new device / technique, including any gaps in the current evidence base
  • The surgeon’s relative inexperience
  • The surgeon’s complication rate(s) thus far
  • Uncertainties related to unforeseeable or unknown risks, due to the experimental, unvalidated nature of the device / technique
  • Any related out-of-pocket costs the patient may incur

Conclusion

New technology has the potential to provide patients with improved clinical outcomes, and surgeons with a competitive edge. However, rather than assuming that ‘new things are always better than old things’, we should adopt a system which integrates: a stepwise search for solid evidence of safety and efficacy; cost-benefit analyses; quality education and training; and a thorough consent process. Doing so will ensure that the evolution of gynaecological surgery is helped, rather than hindered, by innovative devices and techniques.

 

References

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