Pituitary society expert Delphi consensus: operative workflow in endoscopic transsphenoidal pituitary adenoma resection.

PURPOSE: Surgical workflow analysis seeks to systematically break down operations into hierarchal components. It facilitates education, training, and understanding of surgical variations. There are known educational demands and variations in surgical practice in endoscopic transsphenoidal approaches to pituitary adenomas. Through an iterative consensus process, we generated a surgical workflow reflective of contemporary surgical practice. METHODS: A mixed-methods consensus process composed of a literature review and iterative Delphi surveys was carried out within the Pituitary Society. Each round of the survey was repeated until data saturation and > 90% consensus was reached. RESULTS: There was a 100% response rate and no attrition across both Delphi rounds. Eighteen international expert panel members participated. An extensive workflow of 4 phases (nasal, sphenoid, sellar and closure) and 40 steps, with associated technical errors and adverse events, were agreed upon by 100% of panel members across rounds. Both core and case-specific or surgeon-specific variations in operative steps were captured. CONCLUSIONS: Through an international expert panel consensus, a workflow for the performance of endoscopic transsphenoidal pituitary adenoma resection has been generated. This workflow captures a wide range of contemporary operative practice. The agreed "core" steps will serve as a foundation for education, training, assessment and technological development (e.g. models and simulators). The "optional" steps highlight areas of heterogeneity of practice that will benefit from further research (e.g. methods of skull base repair). Further adjustments could be made to increase applicability around the world.

A randomized controlled trial of the X-Stop interspinous distractor device versus laminectomy for lumbar spinal stenosis with 2-year quality-of-life and cost-effectiveness outcomes.

OBJECTIVE: Lumbar spinal stenosis (LSS) is a common and debilitating condition that is increasing in prevalence in the world population. Surgical decompression is often standard treatment when conservative measures have failed. Interspinous distractor devices (IDDs) have been proposed as a safe alternative; however, the associated cost and early reports of high failure rates have brought their use into question. The primary objective of this study was to determine the cost-effectiveness and long-term quality-of-life (QOL) outcomes after treatment of LSS with the X-Stop IDD compared with surgical decompression by laminectomy. METHODS: A multicenter, open-label randomized controlled trial of 47 patients with LSS was conducted; 21 patients underwent insertion of the X-Stop device and 26 underwent laminectomy. The primary outcomes were monetary cost and QOL measured using the EQ-5D questionnaire administered at 6-, 12-, and 24-month time points. RESULTS: The mean monetary cost for the laminectomy group was £2712 ($3316 [USD]), and the mean cost for the X-Stop group was £5148 ($6295): £1799 ($2199) procedural cost plus £3349 mean device cost (£2605 additional cost per device). Using an intention-to-treat analysis, the authors found that the mean quality-adjusted life-year (QALY) gain for the laminectomy group was 0.92 and that for the X-Stop group was 0.81. The incremental cost-effectiveness ratio was -£22,145 (-$27,078). The revision rate for the X-Stop group was 19%. Five patients crossed over to the laminectomy arm after being in the X-Stop group. CONCLUSIONS: Laminectomy was more cost-effective than the X-Stop for the treatment of LSS, primarily due to device cost. The X-Stop device led to an improvement in QOL, but it was less than that in the laminectomy group. The use of the X-Stop IDD should be reserved for cases in which a less-invasive procedure is required. There is no justification for its regular use as an alternative to decompressive surgery. Clinical trial registration no.: ISRCTN88702314 (www.isrctn.com).