Should intermittent pneumatic compression devices be standard therapy for the prevention of venous thromboembolic events in major surgery? Protocol for a randomised clinical trial (IMPOSTERS).

INTRODUCTION: Venous thromboembolism (VTE) is a recognised postsurgical risk. Current prevention methods involve low molecular weight heparin (LMWH), graduated compression stockings (GCS), and intermittent pneumatic compression devices (IPCDs). Australian guidelines, commonly adopted by surgeons, recommend LMWH with GCS and/or IPCDs. IPCDs pose clinical risks, increase care burden, are poorly tolerated, and are costly single-use plastic items. Utilising only LMWH and GCS, without IPCDs, could be more practical, patient-friendly, and cost-effective, with added environmental benefits. METHODS: This is a multicentre, prospective, two-arm randomised controlled non-inferiority trial at five New South Wales (NSW) hospitals, in Australia. We propose to randomise 4130 participants in a 1:1 ratio between arm A: LMWH+GCS+IPCDs (n=2065) or arm B: LMWH+GCS (n=2065). The primary outcome of interest is symptomatic VTE (deep vein thrombosis/pulmonary embolism) identified at the day 30 phone follow-up (FU), confirmed by ultrasound or imaging. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation. Secondary outcomes are quality of life at baseline, days 30 and 90 FU using the 5-level European Quality of Life Score, compliance and adverse events with IPCDs, GCS, and LMWH, as well as healthcare costs (from the perspective of the patient and the hospital), and all-cause mortality. The trial has 90% power to detect a 2% non-inferiority margin to detect a reduction rate of VTE from 4% to 2%. ETHICS AND DISSEMINATION: This study has been approved by the Hunter New England Human Research Ethics Committee (2022/ETH02276) protocol V.10, 13 July 2023. Study findings will be presented at local and national conferences and in scientific research journals. TRIAL REGISTRATION NUMBER: ANZCTR12622001527752.

Interrater reliability of the Clinical Frailty Scale in the anesthesia preadmission clinic.

PURPOSE: As many as 30% of patients with frailty die, are discharged to a nursing home, or have a new disability after surgery. The 2010 United Kingdom National Confidential Enquiry into Patient Outcome and Death recommended that frailty assessment be developed and included in the routine risk assessment of older surgical patients. The Clinical Frailty Scale (CFS) is a simple, clinically-assessed frailty measure; however, few studies have investigated interrater reliability of the CFS in the surgical setting. The objective of this study was to determine the interrater reliability of frailty classification between anesthesiologists and perioperative nurses. METHODS: We conducted a cohort study assessing interrater reliability of the CFS between perioperative nurses and anesthesiologists for elective surgical patients aged ≥ 65 yr, admitted to a large regional university-affiliated hospital in Australia between July 2020 and February 2021. Agreement was measured via Cohen's kappa. RESULTS: Frailty assessment was conducted on 238 patients with a median [interquartile range] age of 74 [70-80] yr. Agreement was perfect between nursing and medical staff for CFS scores in 112 (47%) patients, with a further 99 (42%) differing by only one point. Interrater kappa was 0.70 (95% confidence interval, 0.63 to 0.77; P < 0.001), suggesting good agreement between anesthesiologists and perioperative nurses. CONCLUSION: This study suggests that CFS assessment by either anesthesiologists or nursing staff is reliable across a population of patients from a range of surgical specialities, with an acceptable degree of agreement. The CFS measurement should be included in the normal preanesthesia clinic workflow.

RéSUMé: OBJECTIF: Jusqu'à 30 % de la patientèle fragilisée meurt, est envoyée dans un centre d'hébergement et de soins de longue durée, ou souffre d'une nouvelle invalidité après la chirurgie. L'enquête nationale confidentielle de 2010 du Royaume-Uni sur les Devenirs et les décès des patient·es (National Confidential Enquiry into Patient Outcome and Death) a recommandé que l'évaluation de la fragilité soit élaborée et incluse dans l'évaluation systématique du risque pour la patientèle chirurgicale âgée. L'échelle de fragilité clinique (EFC) est une mesure de la fragilité simple et évaluée cliniquement; cependant, peu d'études ont examiné la fiabilité interévaluateur·trice de cette échelle en milieu chirurgical. L'objectif de cette étude était de déterminer la fiabilité interévaluateur·trice de la classification de la fragilité entre les anesthésiologistes et le personnel infirmier périopératoire. MéTHODE: Nous avons mené une étude de cohorte évaluant la fiabilité interévaluateur·trice de l'EFC entre le personnel infirmier périopératoire et les anesthésiologistes pour la patientèle de chirurgie non urgente âgée de ≥ 65 ans et admise dans un grand hôpital universitaire régional affilié en Australie entre juillet 2020 et février 2021. La concordance a été mesurée via le coefficient Kappa de Cohen. RéSULTATS: Une évaluation de la fragilité a été réalisée pour 238 patient·es dont l'âge médian [écart interquartile] était de 74 ans [70-80]. La concordance dans les scores sur l'EFC était parfaite entre le personnel infirmier et médical pour 112 (47 %) patient·es, et ne différait que d'un point chez 99 autres (42 %) personnes. Le coefficient Kappa était de 0,70 (intervalle de confiance à 95 %, 0,63 à 0,77; P < 0,001), suggérant une bonne concordance entre les anesthésiologistes et le personnel infirmier périopératoire. CONCLUSION: Cette étude suggère que l'évaluation via l'EFC par des anesthésiologistes ou du personnel infirmier est fiable pour une population de patient·es pris·es en charge par diverses spécialités chirurgicales, avec un degré acceptable de concordance. Cette échelle de mesure devrait être incluse dans le flux de travail normal de la clinique de préanesthésie.

Protocol paper for SMART OPS: Shared decision-making Multidisciplinary Approach - a Randomised controlled Trial in the Older adult Population considering Surgery.

INTRODUCTION: The Australian population presenting with surgical pathology is becoming older, frailer and more comorbid. Shared decision-making is rapidly becoming the gold standard of care for patients considering high-risk surgery to ensure that appropriate, value-based healthcare decisions are made. Positive benefits around patient perception of decision-making in the immediacy of the decision are described in the literature. However, short-term and long-term holistic patient-centred outcomes and cost implications for the health service require further examination to better understand the full impact of shared decision-making in this population. METHODS: We propose a novel multidisciplinary shared decision-making model of care in the perioperative period for patients considering high-risk surgery in the fields of general, vascular and head and neck surgery. We assess it in a two arm prospective randomised controlled trial. Patients are randomised to either 'standard' perioperative care, or to a multidisciplinary (surgeon, anaesthetist and end-of-life care nurse practitioner or social worker) shared decision-making consultation. The primary outcome is decisional conflict prior to any surgical procedure occurring. Secondary outcomes include the patient's treatment choice, how decisional conflict changes longitudinally over the subsequent year, patient-centred outcomes including life impact and quality of life metrics, as well as morbidity and mortality. Additionally, we will report on healthcare resource use including subsequent admissions or representations to a healthcare facility up to 1 year. ETHICS AND DISSEMINATION: This study has been approved by the Hunter New England Human Research Ethics Committee (2019/ETH13349). Study findings will be presented at local and national conferences and within scientific research journals. TRIAL REGISTRATION NUMBER: ACTRN12619001543178.