Evaluating the feasibility of implementing a Telesleep pilot program using two-tiered external facilitation

Background: Obstructive sleep apnea (OSA) can negatively impact patients' health status and outcomes. Positive airway pressure (PAP) reverses airway obstruction and may reduce the risk of adverse outcomes. Remote monitoring of PAP (as opposed to in-person visits) may improve access to sleep medicine services. This study aimed to evaluate the feasibility of implementing a clinical program that delivers treatment for OSA through PAP remote monitoring using external facilitation as an implementation strategy. Methods: Participants included patients with OSA at a Veteran Affairs Medical Center (VAMC). PAP adherence and clinical disease severity on treatment (measured by the apnea hypopnea index [AHI]) were the preliminary effectiveness outcomes across two delivery models: usual care (in-person) and Telehealth nurse-delivered remote monitoring. We also assessed visit duration and travel distance. A prospective, mixed-methods evaluation examined the two-tiered external facilitation implementation strategy. Results: The pilot project included N = 52 usual care patients and N = 38 Telehealth nurse-delivered remote monitoring patients. PAP adherence and disease severity were similar across the delivery modalities. However, remote monitoring visits were 50% shorter than in-person visits and saved a mean of 72 miles of travel (median = 45.6, SD = 59.0, mode = 17.8, range 5.4-220). A total of 62 interviews were conducted during implementation with a purposive sample of 12 clinical staff involved in program implementation. Weekly external facilitation delivered to both front-line staff and supervisory physicians was necessary to ensure patient enrollment and treatment. Synchronized, "two-tiered" facilitation at the executive and coordinator levels proved crucial to developing the clinical and administrative infrastructure to support a PAP remote monitoring program and to overcome implementation barriers. Conclusions: Remote PAP monitoring had similar efficacy to in-person PAP services in this Veteran population. Although external facilitation is a widely-recognized implementation strategy in quality improvement projects, less is known about how multiple facilitators work together to help implement complex programs. Two-tiered facilitation offers a model well-suited to programs where innovations span disciplines, disrupt professional hierarchies (such as those between service chiefs, clinicians, and technicians) and bring together providers who do not know each other, yet must collaborate to improve access to care

Brans-Dicke corrections to the gravitational Sagnac effect

The {\it exact} formulation for the effect of the Brans-Dicke scalar field on the gravitational corrections to the Sagnac delay in the Jordan and Einstein frames is presented for the first time. The results completely agree with the known PPN factors in the weak field region. The calculations also reveal how the Brans-Dicke coupling parameter (appears in various correction terms for different types of source/observer orbits. A first order correction of roughly 2.83 x 10^{-1} fringe shift for visible light is introduced by the gravity-scalar field combination for Earth bound equatorial orbits. It is also demonstrated that the final predictions in the two frames do not differ. The effect of the scalar field on the geodetic and Lense-Thirring precession of a spherical gyroscope in circular polar orbit around the Earth is also computed with an eye towards the Stanford Gravity Probe-B experiment currently in progress. The feasibility of optical and matter-wave interferometric measurements is discussed briefly.Comment: 35 pages, 2 figures, pdf (from MSWord), accepted Physical Review D, January 2001. (revised from June 25, 2000 version

Intraoperative Blood Management Strategies for Patients Undergoing Noncardiac Surgery:The Ottawa Intraoperative Transfusion Consensus

IMPORTANCE: There is marked variability in red blood cell (RBC) transfusion during the intraoperative period. The development and implementation of existing clinical practice guidelines have been ineffective in reducing this variability.OBJECTIVE: To develop an internationally endorsed consensus statement about intraoperative transfusion in major noncardiac surgery.EVIDENCE REVIEW: A Delphi consensus survey technique with an anonymous 3-round iterative rating and feedback process was used. An expert panel of surgeons, anesthesiologists, and transfusion medicine specialists was recruited internationally. Statements were informed by extensive preparatory work, including a systematic reviews of intraoperative RBC guidelines and clinical trials, an interview study with patients to explore their perspectives about intraoperative transfusion, and interviews with physicians to understand the various behaviors that influence intraoperative transfusion decision-making. Thirty-eight statements were developed addressing (1) decision-making (interprofessional communication, clinical factors, procedural considerations, and audits), (2) restrictive transfusion strategies, (3) patient-centred considerations, and (4) research considerations (equipoise, outcomes, and protocol suspension). Panelists were asked to score statements on a 7-point Likert scale. Consensus was established with at least 75% agreement.FINDINGS: The 34-member expert panel (14 of 33 women [42%]) included 16 anesthesiologists, 11 surgeons, and 7 transfusion specialists; panelists had a median of 16 years' experience (range, 2-50 years), mainly in Canada (52% [17 of 33]), the US (27% [9 of 33]), and Europe (15% [5 of 33]). The panel recommended routine preoperative and intraoperative discussion between surgeons and anesthesiologists about intraoperative RBC transfusion as well as postoperative review of intraoperative transfusion events. Point-of-care hemoglobin testing devices were recommended for transfusion guidance, alongside an algorithmic transfusion protocol with a restrictive hemoglobin trigger; however, more research is needed to evaluate the use of restrictive triggers in the operating room. Expert consensus recommended a detailed preoperative consent discussion with patients of the risks and benefits of both anemia and RBC transfusion and routine disclosure of intraoperative transfusion. Postoperative morbidity and mortality were recommended as the most relevant outcomes associated with intraoperative RBC transfusion, and transfusion triggers of 70 and 90 g/L were considered acceptable hemoglobin triggers to evaluate restrictive and liberal transfusion strategies, respectively, in clinical trials.CONCLUSIONS AND RELEVANCE: This consensus statement offers internationally endorsed expert guidance across several key domains on intraoperative RBC transfusion practice for noncardiac surgical procedures for which patients are at medium or high risk of bleeding. Future work should emphasize knowledge translation strategies to integrate these recommendations into routine clinical practice and transfusion research activities.</p

Prophylaxis for patients at Risk to Eliminate Post-operative Atrial Fibrillation (PREP-AF trial): a protocol for a feasibility randomized controlled study

Abstract Background Postoperative atrial fibrillation (POAF) is a frequent adverse event after thoracic surgery with associated morbidity, mortality, and healthcare costs. It has been shown to be preventable with prophylactic amiodarone, which is only recommended in high-risk individuals due to the potential associated side effects. Risk factors for POAF have been identified and incorporated into a prediction model to identify high-risk patients. Further evaluation in the form of a multicenter clinical trial is required to assess the effectiveness of prophylaxis specifically in this high-risk population. The feasibility of such a trial first needs to be assessed. Methods The PREP-AF trial is a double-blind randomized controlled feasibility trial. Individuals undergoing major thoracic surgery who are identified to be high-risk by the POAF prediction model will be randomized 1:1 to receive a short course of amiodarone vs. placebo in the immediate postoperative period. The primary outcome is feasibility, which will be measured by the number of eligible patients identified, consented, and randomized; intervention adherence; and measurement of future outcomes of a full trial. Discussion This study will determine the feasibility of a randomized controlled trial to assess the effectiveness of prophylactic amiodarone, in high-risk patients undergoing major thoracic surgery. This will inform the development of a multi-center trial to establish if prophylactic amiodarone is safe and effective at reducing the incidence of POAF. Preventing this adverse event will not only improve outcomes for patients but also reduce the associated health resource utilization and costs. Trial registration ClinicalTrials.gov NCT04392921 . Registered on 19 May 2020

Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2) : study protocol for a phase 3 randomized controlled trial

Introduction: Blood loss and red blood cell (RBC) transfusion in liver surgery are areas of concern for surgeons, anesthesiologists, and patients alike. While various methods are employed to reduce surgical blood loss, the evidence base surrounding each intervention is limited. Hypovolemic phlebotomy, the removal of whole blood from the patient without volume replacement during liver transection, has been strongly associated with decreased bleeding and RBC transfusion in observational studies. This trial aims to investigate whether hypovolemic phlebotomy is superior to usual care in reducing RBC transfusions in liver resection. Methods: This study is a double-blind multicenter randomized controlled trial. Adult patients undergoing major hepatic resections for any indication will be randomly allocated in a 1:1 ratio to either hypovolemic phlebotomy and usual care or usual care alone. Exclusion criteria will be minor resections, preoperative hemoglobin <100g/L, renal insufficiency, and other contraindication to hypovolemic phlebotomy. The primary outcome will be the proportion of patients receiving at least one allogeneic RBC transfusion unit within 30 days of the onset of surgery. Secondary outcomes will include transfusion of other allogeneic blood products, blood loss, morbidity, mortality, and intraoperative physiologic parameters. The surgical team will be blinded to the intervention. Randomization will occur on the morning of surgery. The sample size will comprise 440 patients. Enrolment will occur at four Canadian academic liver surgery centers over a 4-year period. Ethics approval will be obtained at participating sites before enrolment. Discussion: The results of this randomized control trial will provide high-quality evidence regarding the use of hypovolemic phlebotomy in major liver resection and its effects on RBC transfusion. If proven to be effective, this intervention could become standard of care in liver operations internationally and become incorporated within perioperative patient blood management programs.Medicine, Faculty ofNon UBCAnesthesiology, Pharmacology and Therapeutics, Department ofSurgery, Department ofReviewedFacultyResearcherPostdoctoralOthe