Macquarie Surgical Innovation Identification Tool (MSIIT): a study protocol for a usability and pilot test

Blakely, Brette; Selwood, Amanda; Rogers, Wendy; Clay‐Williams, Robyn

doi:10.1136/bmjopen-2016-013704

Cited by 10 publications

(4 citation statements)

References 7 publications

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“…30,31 In our view, the most reliable guideline available to help surgeons determine what qualifies as surgical experimentation is provided by the Royal College of Surgeons 39 and the Macquarie Surgical Innovation Identification Tool. 40 Our recommendations align closely with theirs. Currently, there is no official guideline from the AUA on this matter.…”

Section: The Gray Zone Between Minor Variation and Experimentation On...supporting

confidence: 65%

Exploring the Ethical Gray Zone of Adopting New Surgical Techniques: The Case of Retzius-Sparing Radical Prostatectomy

Arenas-Gallo,

Shoag,

Aulisio

2024

Urology Practice

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Developing, practicing, and implementing novel surgical techniques is imperative for all surgical specialties, but the differences between minor variations, major variations requiring specific informed consent, and human experimentation can sometimes be difficult for surgeons and institutional review boards (IRBs) to establish. Retzius-sparing prostatectomy is a technical modification of conventional prostatectomy, involving substantial changes in surgical steps and anatomic landmarks, with reported improvements in some early outcomes at the cost of a significant learning curve and some uncertainty in long-term oncologic outcomes. Here, we present a review of the ethical considerations of developing new surgical techniques and how they should apply to Retziussparing prostatectomy, the need for special informed consent when a surgeon begins to adopt this approach, and the need for IRB revision when collecting outcomes for publication. Case PresentationDr Scott is a urologist with more than 20 years of experience in robot-assisted laparoscopic prostatectomy (RALP). He recently learned about the Retzius-sparing technique for the treatment of prostate cancer while attending a presentation at a national conference. Some of the published and unpublished data presented suggested that the new technique improves postoperative continence and erectile function. The oncologic results appear not to differ substantially from the standard RALP. After talking to some colleagues who have used this technique, he decided to learn it with the goal of starting to use it at his academic institution. After a hands-on course and several surgeries under the supervision of an experienced surgeon, he believes he is ready to do it on his own. Dr Scott returns to his hospital but is unsure whether he should disclose to his patients that this is the first time he is performing this new procedure in the institution. He feels this could jeopardize patient confidence and the patient-physician relationship. He also does not know whether he should give the patients the option of choosing whether they want to be operated on with the previous technique or simply proceed with the standard informed consent he has been using for his previous RALPs. Finally, he is unsure whether he has an ethical duty to submit a protocol to an IRB to start performing

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Section: The Gray Zone Between Minor Variation and Experimentation On...supporting

confidence: 65%

Exploring the Ethical Gray Zone of Adopting New Surgical Techniques: The Case of Retzius-Sparing Radical Prostatectomy

Arenas-Gallo,

Shoag,

Aulisio

2024

Urology Practice

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“…The lack of a clear definition of surgical innovation makes it difficult to understand when the governance processes for new procedures suggested by NICE and the RCS should be implemented. The Macquarie Surgical Innovation Identification Tool was developed to help surgeons and healthcare providers recognise innovation prospectively, although its usefulness has not yet been established 8 10…”

Section: Introductionmentioning

confidence: 99%

Understanding stage of innovation of invasive procedures and devices: protocol for a systematic review and thematic analysis

et al. 2022

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IntroductionSurgical innovation has generally occurred in an unstandardised manner. This has led to unnecessary exposure of patients to harm, research waste and inadequate evidence. The IDEAL (Idea, Development, Exploration, Assessment, Long-term follow-up) Collaboration provided a set of recommendations for evaluating surgical innovations based on their stage of innovation. Despite further refinements and guidance, adoption of the IDEAL recommendations has been slow; an important reason may be that determining the stage of innovation is often difficult. To facilitate evaluation of surgical innovations, there is a need for a detailed insight into what stage of innovation means, and how it can be determined. The aim of this study is to understand the concept of stage of innovation as reported in the literature.Methods and analysisA systematic review is being conducted. Ovid MEDLINE and Embase databases were searched from their inception until July 2021 using an iteratively developed strategy based on the concepts of stage of innovation, invasive procedures or devices and guidance. Articles were included if they described an approach to evaluating surgical innovations in stages, described a method for determining stage of innovation, described indicators of stage of innovation, defined stages or described potential sources of stage-related information. Conference abstracts and non-English language articles were excluded. Other articles were detected from citations within included articles and suggestions from experts in surgical innovation. Data will be extracted regarding approaches to evaluating surgical innovations, methods for determining stage of innovation, indicators of stage of innovation, definitions of stages and potential sources of stage-related information. A thematic analysis will be conducted, and findings summarised in a narrative report.Ethics and disseminationEthical approval will not be required. This systematic review will be published in a peer-reviewed journal and presented at appropriate conferences.PROSPERO registration numberCRD42021270812.

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“…In response, multiple efforts have created models to guide appropriate adoption and corresponding evaluation that emphasize institutional oversight of new procedures and standardization of processes and outcomes. 44 The IDEAL framework (idea, development/exploration, assessment), 34,45,46 the UCSF model, 47 and the Macquarie Surgical Innovation Identification Tool 31,48 are designed to structure the adoption process for new surgical procedures to improve oversight and demonstrate outcomes.…”

Section: Discussionmentioning

confidence: 99%

How Do Academic Otolaryngologists Decide to Implement New Procedures Into Practice?

Powers

Smith

Arroyo

et al. 2021

Otolaryngol.--head neck surg.

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Objective To identify barriers and facilitators to adoption of a new surgical procedure via an implementation science framework to characterize associated socioemotional, clinical, and decision-making processes. Study Design Qualitative study with a semistructured interview approach. Setting Large tertiary care referral center. Methods Academic otolaryngologists with at least 2 years of practice were identified and interviewed. Transcripts were thematically coded and separated into steps in the clinical pathway. Synthesis of major themes characterized facilitators and barriers to uptake of a new surgical technique. Results Of 22 otolaryngologists, 19 were interviewed (85% male). They had a median 18 years of practice (interquartile range, 7.8-26.3), and 65% were subspecialty trained. In the decision to implement a new procedure, improving patient outcomes and addressing unmet clinical needs facilitated adoption, whereas costs and adopting profit-driven technologies without improved outcomes were barriers. In patient consults, establishing trust facilitated implementation of new techniques; barriers included participants’ hesitation to communicate about the unknowns of a new procedure. Intraoperatively, little change to existing workflow or improved efficiency facilitated adoption, while a substantial learning curve for the new procedure was a barrier. Achieving favorable outcomes and patient satisfaction sustained implementation of new procedures. Too few referrals or indications for the new procedure hindered implementation. Conclusion Our study demonstrates that innovation in otolaryngology is often an individual iterative process that providers pursue to improve patients’ outcomes. Although models for the oversight of surgical innovation emphasize the need for evidence, obtaining sufficient numbers of providers and patients to generate evidence remains a challenge in specialty surgical practice.

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Macquarie Surgical Innovation Identification Tool (MSIIT): a study protocol for a usability and pilot test

Cited by 10 publications

References 7 publications

Exploring the Ethical Gray Zone of Adopting New Surgical Techniques: The Case of Retzius-Sparing Radical Prostatectomy

Exploring the Ethical Gray Zone of Adopting New Surgical Techniques: The Case of Retzius-Sparing Radical Prostatectomy

Understanding stage of innovation of invasive procedures and devices: protocol for a systematic review and thematic analysis

How Do Academic Otolaryngologists Decide to Implement New Procedures Into Practice?

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