Introducing new technology safely into urological practice

Bruwaene, Siska Van; Namdarian, Benjamin; Challacombe, Ben; Eddy, B.; Billiet, Ignace

doi:10.1007/s00345-018-2173-2

Cited by 5 publications

(5 citation statements)

References 30 publications

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“…Standardized education and preceptorship are important parts of the safe introduction of new technologies and procedures into surgical practice. 27,28 For UAS implantation, surgical coaching and cadaveric training allow the surgeon to gain familiarity with proper device setup, surgical anatomy, and operative technique for implantation. For UAS titration, the sponsor also provides standardized programming and training to help guide sleep physicians and sleep lab programming, similar to CPAP titration.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Surgical Learning Curve Effect on Obstructive Sleep Apnea Outcomes in Upper Airway Stimulation

Larsen

Boyd

Villwock

et al. 2020

Ann Otol Rhinol Laryngol

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Objective: An increasing number of facilities offer Upper Airway Stimulation (UAS) with varying levels of experience. The goal was to quantify whether a surgical learning curve exists in operative or sleep outcomes in UAS. Methods: International multi-center retrospective review of the ADHERE registry, a prospective international multi-center study collecting UAS outcomes. ADHERE registry centers with at least 20 implants and outcomes data through at least 6-month follow-up were reviewed. Cases were divided into two groups based on implant order (the first 10 or second 10 consecutive implants at a given site). Group differences were assessed using Mann-Whitney U-tests, Chi-squared tests, or Fisher’s Exact tests, as appropriate. A Mann-Kendall trend test was used to detect if there was a monotonic trend in operative time. Sleep outcome equivalence between experience groups was assessed using the two one-sided tests approach. Results: Thirteen facilities met inclusion criteria, contributing 260 patients. Complication rates did not significantly differ between groups ( P = .808). Operative time exhibited a significant downward trend ( P < .001), with the median operative time dropping from 150 minutes for the first 10 implants to 134 minutes for the subsequent 10 implants. The decrease in AHI from baseline to 12-month follow-up was equivalent between the first and second ten (22.8 vs 21.2 events/hour, respectively, P < .001). Similarly, the first and second ten groups had equivalent ESS decreases at 6 months (2.0 vs 2.0, respectively, P < .001). ESS outcomes remained equivalent for those with data through 12-months. Conclusions: Across the centers’ first 20 implants, an approximately 11% reduction operative time was identified, however, no learning curve effect was seen for 6-month or 12-month AHI or ESS over the first twenty implants. Ongoing monitoring through the ADHERE registry will help measure the impact of evolving provider and patient specific characteristics as the number of implant centers increases.

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Section: Discussionmentioning

confidence: 99%

Evaluation of Surgical Learning Curve Effect on Obstructive Sleep Apnea Outcomes in Upper Airway Stimulation

Larsen

Boyd

Villwock

et al. 2020

Ann Otol Rhinol Laryngol

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“…28 Quantitative observational methods widely used in aviation and automobile industry, such as Statistical Process Control, as well as the IDEAL framework, provide solutions to many of the problems inherent to RCTs and assure patient safety and quality assessment during introduction of new technology in surgical procedures. 29,30 Statistical Process Control (SPC) helps in monitoring new procedures in a predefined frame, as has been successfully shown in manufacturing lines. It allows early detection and prevention of problems and could be transferred to the operating theater to monitor the introduction of novel procedures in surgery.…”

Section: Discussionmentioning

confidence: 99%

Procedural Surgical RCTs in Daily Practice

Oberkofler¹,

Hamming²,

Staiger³

et al. 2019

Annals of Surgery

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OBJECTIVE: To assess the adoption of recommendation from randomized clinical trials (RCTs) and investigate factors favoring or preventing adoption. BACKGROUND: RCT are considered to be the cornerstone of evidence-based medicine by representing the highest level of evidence. As such, we expect RCT's recommendations to be followed rigorously in daily surgical practice. METHODS: We performed a structured search for RCTs published in the medical and surgical literature from 2009 to 2013, allowing a minimum of 5-year follow-up to convincingly test implementation. We focused on comparative technical or procedural RCTs trials addressing the domains of general, colorectal, hepatobiliary, upper gastrointestinal and vascular surgery. In a second step we composed a survey of 29 questions among ESA members as well as collaborators from their institutions to investigate the adoption of surgical RCTs recommendation. RESULTS: The survey based on 36 RCTs (median 5-yr citation index 85 (24-474), from 21 different countries, published in 15 high-ranked journals with a median impact factor of 3.3 (1.23-7.9) at the time of publication. Overall, less than half of the respondents (47%) appeared to adhere to the recommendations of a specific RCT within their field of expertise, even when included in formal guidelines. Adoption of a new surgical practice was favored by watching videos (46%) as well as assisting live operations (18%), while skepticism regarding the methodology of a surgical RCT (40%) appears to be the major reason to resist adoption. CONCLUSION: In conclusion, surgical RCTs appear to have moderate impact on daily surgical practice. While RCTs are still accepted to provide the highest level of evidence, alternative methods of evaluating surgical innovations should also be explored.

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“…As we move forward in urology there can be no denying that advances have come in many shapes and forms, particularly in the past decade or so: robotic-assisted laparoscopic surgery, digital formats including histopathology and imaging, 3-D printing, interventional radiological techniques, singleuse flexible pyeloscopy, mini-percutaneous nephrolithotomy, new biomaterials, positron emission tomography computed tomography (PET-CT) relevant in prostate cancer to name a few [1][2][3][4][5][6][7][8][9][10][11]. These are all advances that have been embraced with great enthusiasm and are discussed in this topic issue.…”

mentioning

confidence: 99%

“…However, how do we introduce, and train for these new technologies? [4,12]. Perhaps, more importantly, how are they funded and are they cost effective?…”

mentioning

confidence: 99%