Publications by authors named "Heels-Ansdell D"
Background: Understanding site-related factors that influence enrolment within multicenter randomized controlled trials (RCT) may help reduce trial delays and cost over-runs and prevent early trial discontinuation. In this analysis of PROSPECT (Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial), we describe patient enrolment patterns and examine factors influencing site-based monthly enrolment.
Design: Retrospective analysis of a multicenter RCT.
Article Synopsis
- Survivors of critical illness often experience physical dysfunction post-ICU discharge, and the CYCLE trial aims to evaluate the effectiveness of in-bed cycle ergometry for improving short-term physical function in these patients.!* -
- The CYCLE trial, involving 360 patients across multiple centers, employs a prespecified statistical analysis plan to assess outcomes like the PFIT-s score three days after ICU discharge, while considering variables such as age, frailty, and sex.!* -
- Funded in 2017, the CYCLE study completed enrollment in May 2023, with data analyses finished and first results expected to be published in 2024.!*
Objective: To determine timing and risk factors associated with readmission within 30 days of discharge following noncardiac surgery.
Background: Hospital readmission after noncardiac surgery is costly. Data on the drivers of readmission have largely been derived from single-center studies focused on a single surgical procedure with uncertainty regarding generalizability.
Article Synopsis
- A study was conducted to evaluate the effects of the proton-pump inhibitor pantoprazole on critically ill patients undergoing invasive ventilation, comparing it to a placebo.
- The trial included 4,821 patients and found that pantoprazole significantly reduced the incidence of clinically important upper gastrointestinal bleeding compared to placebo (1.0% vs. 3.5%).
- However, there was no significant difference in overall mortality rates at 90 days between the pantoprazole group (29.1%) and the placebo group (30.9%).
Background: The goal of this systematic review was to examine the efficacy and safety of proton-pump inhibitors for stress ulcer prophylaxis in critically ill patients.
Methods: We included randomized trials comparing proton-pump inhibitors versus placebo or no prophylaxis in critically ill adults, performed meta-analyses, and assessed certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluations approach. To explore the effect of proton-pump inhibitors on mortality based on disease severity, a subgroup analysis was conducted combining within-trial subgroup data from the two largest trials and assessed credibility using the Instrument for Assessing the Credibility of Effect Modification Analyses.
Article Synopsis
- Critical illness requiring invasive mechanical ventilation can lead to significant physical disability, and early in-bed cycle ergometry may help reduce this impairment when added to standard physiotherapy in ICU patients.
- A study with 360 adult patients randomly assigned to either early in-bed cycling plus usual physiotherapy or just usual physiotherapy found no significant difference in physical function scores three days after ICU discharge.
- The addition of cycling did not result in any serious adverse events, indicating it is safe, but did not enhance recovery outcomes compared to standard therapy alone.
Objective: To determine the epidemiology of post-operative complications among general surgery patients, inform their relationships with 30-day mortality, and determine the attributable fraction of death of each postoperative complication.
Background: The contemporary causes of post-operative mortality among general surgery patients are not well characterized.
Methods: VISION is a prospective cohort study of adult non-cardiac surgery patients across 28 centres in 14 countries, who were followed for 30 days after surgery.
Introduction: Troponin elevation after noncardiac surgery is associated with an elevated risk of 30-day mortality. Little is known about relative merit of using a high-sensitivity Troponin T (hsTnT), the fifth-generation assay, vs the nonhigh sensitivity Troponin T (non-hsTnT), the fourth-generation assay, in the noncardiac surgery setting. We aimed to identify whether hsTnT can identify additional patients at risk that would have gone undetected with non-hsTnT measurement.
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- During the COVID-19 pandemic, many ICUs paused ongoing research to prioritize studies related to the virus, but the REVISE trial continued investigating stress ulcer prophylaxis in mechanically ventilated patients.
- The trial, which compares pantoprazole against a placebo, enrolled 2,961 patients across 59 centers, despite facing disruptions in enrollment during the pandemic.
- Changes in the informed consent process included a shift to a 'consent to continue' model and an increase in telephone consent due to restrictions, leading to a slight rise in overall consent rates.
Background: Proton pump inhibitors (PPIs) are the most commonly prescribed drugs for preventing upper gastrointestinal bleeding in critically ill patients. However, concerns have arisen about the possible harms of using PPIs, including potentially increased risk of pneumonia, Clostridioides difficile infection, and more seriously, an increased risk of death in the most severely ill patients. Triggered by the REVISE trial, which is a forthcoming large randomized trial comparing pantoprazole to placebo in invasively mechanically ventilated patients, we will conduct this systematic review to evaluate the efficacy and safety of PPIs versus no prophylaxis for critically ill patients.
View Article and Find Full Text PDFBackground: Ascertainment of the severity of the primary outcome of upper gastrointestinal (GI) bleeding is integral to stress ulcer prophylaxis trials. This protocol outlines the adjudication process for GI bleeding events in an international trial comparing pantoprazole to placebo in critically ill patients (REVISE: Re-Evaluating the Inhibition of Stress Erosions). The primary objective of the adjudication process is to assess episodes submitted by participating sites to determine which fulfil the definition of the primary efficacy outcome of clinically important upper GI bleeding.
View Article and Find Full Text PDFLow testosterone (T), common in aging men, associates with cardiovascular disease. We investigated whether follicle-stimulating hormone (FSH), which is affected by T, modulates the cardiovascular effects associated with low T or castration. FSHβ:low-density lipoprotein receptor (LDLR) mice, untreated or castrated (orchiectomy, gonadotropin-releasing hormone agonist or antagonist), demonstrated significantly less atherogenesis compared with similarly treated LDLR mice, but not following FSH delivery.
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- A study conducted at 25 hospitals compared the effectiveness of two antiseptic solutions (iodine povacrylex and chlorhexidine gluconate) in preventing surgical-site infections during extremity fracture surgeries.
- Results showed that iodine povacrylex led to a lower rate of infections in patients with closed fractures (2.4% vs. 3.3%) but did not show a significant difference for open fractures (6.5% vs. 7.3%).
- Ultimately, the study concluded that iodine povacrylex is a more effective skin antiseptic for closed extremity fractures, resulting in fewer infections compared to chlorhexidine, though both had similar outcomes for reoperations and adverse events.
Background: The REVISE (Re-Evaluating the Inhibition of Stress Erosions in the ICU) trial will evaluate the impact of the proton pump inhibitor pantoprazole compared to placebo in invasively ventilated critically ill patients.
Objective: To outline the statistical analysis plan for the REVISE trial.
Methods: REVISE is a randomized clinical trial ongoing in intensive care units (ICUs) internationally.
Introduction: The e-aluating the nhibition of tress rosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE.
Methods And Analysis: REVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil.
Background: In previous analyses, myocardial injury after noncardiac surgery, major bleeding, and sepsis were independently associated with most deaths in the 30 days after noncardiac surgery, but most of these deaths occurred during the index hospitalization for surgery. The authors set out to describe outcomes after discharge from hospital up to 1 yr after inpatient noncardiac surgery and associations between predischarge complications and postdischarge death up to 1 yr after surgery.
Methods: This study was an analysis of patients discharged after inpatient noncardiac surgery in a large international prospective cohort study across 28 centers from 2007 to 2013 of patients aged 45 yr or older followed to 1 yr after surgery.
Article Synopsis
- Critically ill patients in ICUs often receive proton pump inhibitors (PPIs) to prevent GI bleeding, but there are concerns about their safety, especially for those with COVID-19 infection.
- This study is part of a larger trial testing pantoprazole against a placebo and aims to analyze patient characteristics, the effect of COVID-19 on GI bleeding and mortality, and whether pantoprazole influences outcomes differently in COVID-19 patients.
- The research includes a detailed examination of various clinical factors such as biomarkers, thromboembolism, and treatment outcomes, focusing on how these relate to both infected and non-infected cohorts.
Objective: The objective of this study was to determine the prognostic relevance, clinical characteristics, and 30-day outcomes associated with myocardial injury after noncardiac surgery (MINS) in major general surgery patients.
Background: MINS has been independently associated with 30-day mortality after noncardiac surgery. The characteristics and prognostic importance of MINS in major general surgical patients have not been described.
Background: Patients with a tibial shaft fracture experiencing their first postoperative complication following treatment with intramedullary nails may be at greater risk of subsequent complications than the whole population. We aimed to determine whether the initial method of nail insertion influences outcome in patients with a tibial shaft fracture requiring multiple reoperations.
Methods: Using the Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures trial data, we categorized patients as those not requiring reoperation, those requiring a single reoperation and those requiring multiple reoperations, and we compared them by nail insertion technique (reamed v.
Introduction: In-bed leg cycling with critically ill patients is a promising intervention aimed at minimising immobility, thus improving physical function following intensive care unit (ICU) discharge. We previously completed a pilot randomised controlled trial (RCT) which supported the feasibility of a large RCT. In this report, we describe the protocol for an international, multicentre RCT to determine the effectiveness of early in-bed cycling versus routine physiotherapy (PT) in critically ill, mechanically ventilated adults.
View Article and Find Full Text PDFPurpose: Venous thromboembolism (VTE) is a common complication of critical illness. Sex- or gender-based analyses are rarely conducted and their effect on outcomes is unknown. We assessed for an effect modification of thromboprophylaxis (dalteparin or unfractionated heparin [UFH]) by sex on thrombotic (deep venous thrombosis [DVT], pulmonary embolism [PE], VTE) and mortality outcomes in a secondary analysis of the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT).
View Article and Find Full Text PDFBackground: The association between growth differentiation factor-15 concentrations and cardiovascular disease has been well described. The study hypothesis was that growth differentiation factor-15 may help cardiac risk stratification in noncardiac surgical patients, in addition to clinical evaluation.
Methods: The objective of the study was to determine whether preoperative serum growth differentiation factor-15 is associated with the composite primary outcome of myocardial injury after noncardiac surgery and vascular death at 30 days and can improve cardiac risk prediction in noncardiac surgery.
Article Synopsis
- The study analyzed ICU-acquired pneumonia using seven different definitions to estimate hospital mortality rates.
- It was part of a larger trial involving 2,650 mechanically ventilated adults, where pneumonia cases were reviewed by two blinded physicians.
- Different definitions showed varying rates of pneumonia incidence, with some, like ventilator-associated pneumonia (VAP) and Clinical Pulmonary Infection Score (CPIS), linked to a higher risk of hospital mortality.
Background: Initially developed in the intensive care unit (ICU) at St. Joseph's Healthcare Hamilton (SJHH) the 3 Wishes Project (3WP) provides personalized, compassionate care to dying patients and their families. The objective of this study was to develop and evaluate 3WP expansion strategies for patients cared for on General Internal Medicine (GIM) wards in our hospital.
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