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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. Methods: We will systematically search randomized trials that compared gastrointestinal bleeding prophylaxis with PPIs versus placebo or no prophylaxis in adults in the intensive care unit (ICU). Pairs of reviewers will independently screen the literature, and for those eligible trials, extract data and assess risk of bias. We will perform meta‐analyses using a random‐effects model, and calculate relative risks for dichotomous outcomes and mean differences for continuous outcomes, and the associated 95% confidence intervals. We will conduct subgroup analysis to explore whether the impact of PPIs on mortality differs in more and less severely ill patients. We will assess certainty of evidence using the GRADE approach. Discussion: This systematic review will provide the most up‐to‐date evidence regarding the merits and limitations of stress ulcer prophylaxis with PPIs in critically ill patients in contemporary practice. [ABSTRACT FROM AUTHOR]

Background: During the COVID-19 pandemic, many intensive care units (ICUs) halted research to focus on COVID-19-specific studies. Objective: To describe the conduct of an international randomized trial of stress ulcer prophylaxis (Re-Evaluating the Inhibition of Stress Erosions in the ICU [REVISE]) during the pandemic, addressing enrolment patterns, center engagement, informed consent processes, data collection, a COVID-specific substudy, patient transfers, and data monitoring. Methods: REVISE is a randomized trial among mechanically ventilated patients, comparing pantoprazole 40 mg IV to placebo on the primary efficacy outcome of clinically important upper gastrointestinal bleeding and the primary safety outcome of 90-day mortality. We documented protocol implementation status from March 11th 2020-August 30th 2022. Results: The Steering Committee did not change the scientific protocol. From the first enrolment on July 9th 2019 to March 10th 2020 (8 months preceding the pandemic), 267 patients were enrolled in 18 centers. From March 11th 2020-August 30th 2022 (30 months thereafter), 41 new centers joined; 59 were participating by August 30th 2022 which enrolled 2961 patients. During a total of 1235 enrolment-months in the pandemic phase, enrolment paused for 106 (8.6%) months in aggregate (median 3 months, interquartile range 2;6). Protocol implementation involved a shift from the a priori consent model pre-pandemic (188, 58.8%) to the consent to continue model (1615, 54.1%, p < 0.01). In one new center, an opt-out model was approved. The informed consent rate increased slightly (80.7% to 85.0%, p = 0.05). Telephone consent encounters increased (16.6% to 68.2%, p < 0.001). Surge capacity necessitated intra-institutional transfers; receiving centers continued protocol implementation whenever possible. We developed a nested COVID-19 substudy. The Methods Centers continued central statistical monitoring of trial metrics. Site monitoring was initially remote, then in-person when restrictions lifted. Conclusion: Protocol implementation adaptations during the pandemic included a shift in the consent model, a sustained high consent rate, and launch of a COVID-19 substudy. Recruitment increased as new centers joined, patient transfers were optimized, and monitoring methods were adapted. [ABSTRACT FROM AUTHOR]

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. Patients ≥ 18 years old, receiving invasive mechanical ventilation, and expected to remain ventilated beyond the calendar day after randomization are allocated to either 40 mg pantoprazole intravenously or placebo while mechanically ventilated. Results: The primary efficacy outcome is clinically important upper GI bleeding; the primary safety outcome is 90-day mortality. Secondary outcomes are ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine concentration, and duration of mechanical ventilation, ICU, and hospital length of stay. Following an interim analysis of results from 2400 patients (50% of 4800 target sample size), the data monitoring committee recommended continuing enrolment. Conclusions: This statistical analysis plan outlines the statistical analyses of all outcomes, sensitivity analyses, and subgroup analyses. REVISE will inform clinical practice and guidelines worldwide. Trial registration: www.ClinicalTrials.gov NCT03374800. November 21, 2017. [ABSTRACT FROM AUTHOR]

Background: Critically ill patients commonly receive proton pump inhibitors (PPIs) to prevent gastrointestinal (GI) bleeding from stress-induced ulceration. Despite widespread use in the intensive care unit (ICU), observational data suggest that PPIs may be associated with adverse outcomes in patients with COVID-19 infection. This preplanned study is nested within a large randomized trial evaluating pantoprazole versus placebo in invasively ventilated patients. The 3 objectives are as follows: (1) to describe the characteristics of patients with COVID-19 in terms of demographics, biomarkers, venous thromboembolism, tracheostomy incidence and timing, and other clinical outcomes; (2) to evaluate the impact of COVID-19 infection on clinically important GI bleeding, 90-day mortality, and other outcomes compared to a propensity-matched non-infected cohort; and (3) to explore whether pantoprazole has a differential treatment effect on clinically important GI bleeding, 90-day mortality, and other outcomes in patients with and without COVID-19 infection. Methods: The ongoing trial Re-EValuating the Inhibition of Stress Erosions (REVISE) compares pantoprazole 40 mg IV to placebo on the primary efficacy outcome of clinically important GI bleeding and the primary safety outcome of 90-day mortality. The protocol described in this report is for a substudy focused on patients with COVID-19 infection that was not in the original pre-pandemic trial protocol. We developed a one-page case report form to characterize these patients including data related to biomarkers, venous thromboembolism, COVID-19 therapies, tracheostomy incidence and timing, duration of mechanical ventilation, and ICU and hospital stay. Our analysis will describe the trajectory of patients with COVID-19 infection, a propensity-matched analysis of infected and non-infected patients, and an extended subgroup analysis comparing the effect of PPI among patients with and without COVID-19 infection. Discussion: Prophylactic acid suppression in invasively ventilated critically ill patients with COVID-19 infection has unknown consequences. The results of these investigations will inform practice, guidelines, and future research. Trial registration: REVISE Trial [NCT03374800 December 15, 2017], COVID-19 Cohort Study [NCT05715567 February 8, 2023]. [ABSTRACT FROM AUTHOR]

Copyright of Canadian Journal of Surgery is the property of CMA Impact Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Canadian Journal of Anaesthesia / Journal Canadien d'Anesthésie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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. Methods: From January 2020-November 2021, we developed a phased, multicomponent approach for program expansion. We enrolled patients on the GIM wards who had a high probability of dying in hospital, then elicited, implemented, and documented wishes for them or their families. Data were analyzed descriptively. Results: From March 2020 to November 2020, we implemented staff education and engagement activities, created an Expansion Coordinator position, held strategic consultations, and offered enabling resources. From March 2020 to November 2021, we enrolled 62 patients and elicited 281 wishes (median [1st, 3rd quartiles] 4 [4, 5] wishes/patient). The most common wish categories were personalizing the environment (67 wishes, 24%), rituals and spiritual support (42 wishes, 15%), and facilitating connections (39 wishes, 14%). The median [1st, 3rd] cost/patient was $0 [0, $10.00] (range $0 to $86); 91% of wishes incurred no cost to the program. Conclusions: The formal expansion of the 3WP on GIM wards has been successful despite COVID-19 pandemic disruptions. While there is still work ahead, these data suggest that implementing the 3WP on the GIM wards is feasible and affordable. Increased engagement of the clinical team during the pandemic suggests that it is positively received. [ABSTRACT FROM AUTHOR]

Copyright of Canadian Journal of Anaesthesia / Journal Canadien d'Anesthésie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background and Objectives: Functional outcomes are important for oncology patients undergoing lower extremity reconstruction. The objective of the current study was to describe patient reported function after surgery and identify predictors of postoperative function in musculoskeletal oncology patients undergoing lower extremity endoprosthetic reconstruction. Methods: We performed a cohort study with functional outcome data from the recently completed Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial. We utilized the 100-point Toronto Extremity Salvage Score (TESS), which was administered pre-operatively and at 3, 6 and 12 months post-operatively. Higher scores indicate better physical functioning, and the minimally important difference is 11 points. We calculated mean functional scores at each timepoint after surgery and developed a logistic regression model to explore predictors of failure to achieve excellent post-operative function (TESS ≥ 80) at 1 year after surgery. Results: The 555 patients included in our cohort showed important functional improvement from pre-surgery to 1 year post-surgery (mean difference 14.9 points, 95%CI 12.2 to 17.6; p < 0.001) and 64% achieved excellent post-operative function. Our adjusted regression model found that poor (TESS 0–39) pre-operative function (odds ratio [OR] 3.3, 95%CI 1.6 to 6.6); absolute risk [AR] 24%, 95%CI 8% to 41.2%), older age (OR per 10-year increase from age 12, 1.32, 95%CI 1.17, 1.49; AR 4.5%, 95%CI 2.4% to 6.6%), and patients undergoing reconstruction for soft-tissue sarcomas (OR 2.3, 95%CI 1.03 to 5.01; AR 15.3%, 95%CI 0.4% to 34.4%), were associated with higher odds of failing to achieve an excellent functional outcome at 1-year follow-up. Patients undergoing reconstruction for giant cell tumors were more likely to achieve an excellent functional outcome post-operatively (OR 0.40, 95%CI 0.17 to 0.95; AR −9.9%, 95%CI −14.4% to −0.7%). Conclusions: The majority of patients with tumors of the lower extremity undergoing endoprosthetic reconstruction achieved excellent function at 1 year after surgery. Older age, poor pre-operative function, and endoprosthetic reconstruction for soft tissue sarcomas were associated with worse outcomes; reconstruction for giant cell tumors was associated with better post-operative function. Level of Evidence: Therapeutic Level IV. [ABSTRACT FROM AUTHOR]

Background: Approximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020.Methods and Design: The Aqueous-PREP trial is a pragmatic, multicenter, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites.Results: The primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention's National Healthcare Safety Network reporting criteria (2017). All participants' surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections [1]. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture.Conclusion: This manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022. [ABSTRACT FROM AUTHOR]

Background: The purpose of this pilot study was to validate the feasibility of a definitive study aimed at determining if high-intensity physical activity during adolescence impacts the development of femoroacetabular impingement (FAI). Methods: This prospective cohort pilot study had a sample size target of 50 volunteers between 12 and 14 years old at sites in Canada, South Korea, and the Netherlands. Participants were evaluated clinically and radiographically at baseline and at 2 years. The participants' sport and physical activity were evaluated using the Habitual Activity Estimation Scale (HAES) and the American Orthopaedic Society for Sports Medicine (AOSSM) criteria for sport specialization. The primary outcome was feasibility and secondary outcomes included the incidence of radiographic FAI and hip range of motion, function (Hip Outcome Score, HOS), and quality of life (Pediatric Quality of Life questionnaire, PedsQL) at 24 months. Study groups were defined at the completion of follow-up, given the changes in participant activity levels over time. Results: Of the 54 participants enrolled, there were 36 (33% female) included in the final analysis. At baseline, those classified as highly active and played at least one organized sport had a higher incidence of asymptomatic radiographic FAI markers (from 6/32, 18.8% at baseline to 19/32, 59.4% at 24 months) compared to those classified as low activity (1/4, 25% maintained at baseline and 24 months). The incidence of radiographic FAI markers was higher among sport specialists (12/19, 63.2%) compared to non-sport specialists (8/17, 47.1%) at 24 months. The HOS and PedsQL scores were slightly higher (better) among those that were highly active and played a sport compared to those who did not at 2 years (mean difference (95% confidence interval): HOS-ADL subscale 4.56 (− 7.57, 16.70); HOS-Sport subscale 5.97 (− 6.91, 18.84); PedsQL Physical Function 7.42 (− 0.79, 15.64); PedsQL Psychosocial Health Summary 6.51 (− 5.75, 18.77)). Conclusion: Our pilot study demonstrated some feasibility for a larger scale, definitive cohort study. The preliminary descriptive data suggest that adolescents engaged in higher levels of activity in sports may have a higher risk of developing asymptomatic hip deformities related to FAI but also better quality of life over the 2-year study period. [ABSTRACT FROM AUTHOR]

The goal of this study was to investigate the sexual and urinary function and any related complications in patients post-hip arthroscopy for the treatment of femoroacetabular impingement (FAI). Data from 214 patients enrolled in the FIRST trial and 110 patients enrolled in the trial's embedded prospective cohort study (EPIC) were analyzed. EPIC patients either refused to participate in the trial or did not meet the FIRST eligibility criteria. Outcomes included the International Consultation on Continence Questionnaire (ICIQ) for males (ICIQ-MLUTS) and females (ICIQ-FLUTS) and the Female Sexual Function Index (FSFI) and International Index of Erectile Function (IIEF) administered before surgery and at 6 weeks and 12 months. Urinary and sexual function adverse events were recorded up to 24 months. Linear regression analyses were conducted to compare the osteochondroplasty and lavage groups in the FIRST trial and to evaluate age and traction time as prognostic factors among all patients. Longer traction time was associated with a small but statistically significant improvement in urinary voiding function in males at 6 weeks and 12 months (MD (95% CI) = 0.25 (0.12, 0.39), P  < 0.001 and 0.21 (0.07, 0.35), P  = 0.004), respectively. Mean traction time was 43.7 (± 23.2) min for FIRST trial and 52.8 (± 15.2) min for EPIC cohort patients. Increasing age in male patients was associated with a decrease in urinary continence at 6 weeks (MD (95% CI) = 0.25 (−0.42, −0.09), P  = 0.003). FIRST male patients who received osteochondroplasty improved significantly in sexual function at 12 months compared to males in the EPIC cohort (MD (95% CI) = 2.02 (0.31, 3.72), P  = 0.020). There was an overall complication rate of 1.2% at 24 months [one urinary infection, two instances of erectile dysfunction (one transient and one ongoing at 24 months) and one reported transient numbness of tip of the penis]. Hip arthroscopy for the treatment of FAI has a low rate of sexual and urinary dysfunction and adverse events. [ABSTRACT FROM AUTHOR]

Importance: Growing interest in microbial dysbiosis during critical illness has raised questions about the therapeutic potential of microbiome modification with probiotics. Prior randomized trials in this population suggest that probiotics reduce infection, particularly ventilator-associated pneumonia (VAP), although probiotic-associated infections have also been reported.Objective: To evaluate the effect of Lactobacillus rhamnosus GG on preventing VAP, additional infections, and other clinically important outcomes in the intensive care unit (ICU).Design, Setting, and Participants: Randomized placebo-controlled trial in 44 ICUs in Canada, the United States, and Saudi Arabia enrolling adults predicted to require mechanical ventilation for at least 72 hours. A total of 2653 patients were enrolled from October 2013 to March 2019 (final follow-up, October 2020).Interventions: Enteral L rhamnosus GG (1 × 1010 colony-forming units) (n = 1321) or placebo (n = 1332) twice daily in the ICU.Main Outcomes and Measures: The primary outcome was VAP determined by duplicate blinded central adjudication. Secondary outcomes were other ICU-acquired infections including Clostridioides difficile infection, diarrhea, antimicrobial use, ICU and hospital length of stay, and mortality.Results: Among 2653 randomized patients (mean age, 59.8 years [SD], 16.5 years), 2650 (99.9%) completed the trial (mean age, 59.8 years [SD], 16.5 years; 1063 women [40.1%.] with a mean Acute Physiology and Chronic Health Evaluation II score of 22.0 (SD, 7.8) and received the study product for a median of 9 days (IQR, 5-15 days). VAP developed among 289 of 1318 patients (21.9%) receiving probiotics vs 284 of 1332 controls (21.3%; hazard ratio [HR], 1.03 (95% CI, 0.87-1.22; P = .73, absolute difference, 0.6%, 95% CI, -2.5% to 3.7%). None of the 20 prespecified secondary outcomes, including other ICU-acquired infections, diarrhea, antimicrobial use, mortality, or length of stay showed a significant difference. Fifteen patients (1.1%) receiving probiotics vs 1 (0.1%) in the control group experienced the adverse event of L rhamnosus in a sterile site or the sole or predominant organism in a nonsterile site (odds ratio, 14.02; 95% CI, 1.79-109.58; P < .001).Conclusions and Relevance: Among critically ill patients requiring mechanical ventilation, administration of the probiotic L rhamnosus GG compared with placebo, resulted in no significant difference in the development of ventilator-associated pneumonia. These findings do not support the use of L rhamnosus GG in critically ill patients.Trial Registration: ClinicalTrials.gov Identifier: NCT02462590. [ABSTRACT FROM AUTHOR]

Background: Heterotopic ossification (HO) is a frequent complication following hip surgery. Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we aimed to (1) determine the prevalence of HO following total hip arthroplasty (THA) for femoral neck fracture in patients ≥50 years of age, (2) identify whether HO is associated with an increased risk of revision surgery within 24 months after the fracture, and (3) determine the impact of HO on functional outcomes.Methods: We performed a multivariable Cox regression analysis using revision surgery as the dependent variable and HO as the independent variable. We compared Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores between participants with and those without HO at 24 months.Results: Of 1,441 participants in the study, 287 (19.9%) developed HO within 24 months. HO was not associated with subsequent revision surgery. Grade-III HO was associated with statistically significant and clinically relevant deterioration in the total WOMAC score, which was mainly related to the function component of the score, compared with grade I or II.Conclusions: The impact of grade-III HO on the functional outcomes and quality of life after THA for hip fracture is clinically important, and HO prophylaxis for selected high-risk patients may be appropriate.Level Of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Background: The 3 Wishes Project (3WP) promotes a personalized dying experience by eliciting and facilitating individualized terminal wishes for patients, families and the clinicians caring for them. We aimed to evaluate the adaptability of the 3WP to a community intensive care unit (ICU), and to describe the patients cared for with this palliative approach, as well as local implementation strategies. Methods: The 3WP was implemented in a 15-bed community hospital ICU in southern Ontario from 2017 to 2019. In this observational, descriptive study, we invited adult patients (≥ 18 yr) whose risk of death was deemed to be 95% or greater by the attending physician, or patients undergoing withdrawal of life-support to participate. We abstracted patient data from medical records, as well as the type, timing and cost of each wish, which person or service made and facilitated each wish, and if and why wishes were completed or not. We summarized data both narratively and quantitatively. Results: The 3WP helped to realize 479 (99.2%) of 483 terminal wishes for 101 dying patients. This initiative was introduced as an interprofessional intervention and championed by nursing staff who were responsible for most patient enrolment and wish facilitation. Wishes included humanizing the ICU environment for the patient with belongings and blankets, musical performances, smudging and bathing ceremonies, and keepsakes. The cost was $5.39 per patient (standard deviation $22.40), with 430 (89.8%) wishes incurring no cost. Wishes made directly by patients accounted for 30 (6.2%) of wishes; those from family members and ICU staff accounted for 236 (48.9%) and 238 (49.3%) of wishes, respectively. The program comforted patients and their loved ones, motivating clinicians to sustain this end-of-life intervention. Interpretation: We documented successful implementation of the 3WP in a community hospital, showing program adaptability and uptake outside of academic centres at relatively low cost. The lack of strict protocolization and personalized design of this intervention underscores its inherent flexibility, with potential to promote individualized end-of-life care in nonacademic hospital wards, homes or hospice. [ABSTRACT FROM AUTHOR]

Copyright of Canadian Journal of Surgery is the property of CMA Impact Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: To understand the early outcomes after hip arthroscopy and better define the trajectory of improvement in a prospective cohort of patients who have undergone hip arthroscopic osteochondroplasty for femoroacetabular impingement (FAI) syndrome. Methods: Data were analyzed from the Femoroacetabular Impingement RandomiSed controlled Trial (FIRST) on the 108 study patients who underwent osteochondroplasty, with or without labral repair. Study outcomes included patient-reported pain (using a 100-point Visual Analogue Scale (VAS)), hip function (using the Hip Outcome Score (HOS) and International Hip Outcome Tool (iHOT-12)), and health-related quality of life (using the EuroQol 5 Dimensions (EQ-5D)) measured at baseline, 2 weeks, 3 months, 6 months, and 12 months post-operatively. Results: There was a decrease in mean post-operative pain VAS scores from baseline. The first 2 weeks post-operative yielded the greatest reduction in pain with a mean (SD) VAS score of 37.8 (23.4), with score stabilization between 6 months (26.9 (26.9)) and 12 months (25.3 (27.6)). Mean HOS (activities of daily living) scores improved from baseline (59.7 (16.2)) starting at 6 weeks post-operative (64.1 (19.1)). The HOS (Sports) showed no improvement from baseline (41.2 (20.4)) until 3 months (49.1 (27.9)), and continued to improve at 6 months (64.1 (28.7)) and 12 months (68.6 (30.5)). The iHOT-12 scores showed functional improvement from baseline (31.3 (18.8)), as early as 6 weeks (44.9 (22.4)) up to and including 12 months (67.1 (29.7)). EQ-5D index scores showed modest steady improvement from 6 weeks to 12 months post-operative, while the EQ-5D VAS component similarly showed modest and steady improvements from 3 months onward. Conclusion: Results from this study highlight that hip arthroscopic osteochondroplasty with or without labral repair for FAI leads to early pain relief. While all scores improved from baseline, functional gains appear to plateau from 6 months onwards. These data can be used to inform decision-making about timelines for rehabilitation and return to sport, a knowledge gap in the current FAI literature. Level of evidence: II. [ABSTRACT FROM AUTHOR]

Purpose: To identify patient factors associated with improved pain scores, functional hip scores, health-related quality of life, and re-operation rates after arthroscopic management of femoroacetabular impingement (FAI). Methods: Using the comprehensive dataset from the multinational Femoroacetabular Impingement Randomized Controlled Trial (FIRST), a total of 13 prognostic factors that were chosen a priori were identified that would be expected to predict post-surgical outcomes. The primary outcome was pain assessed using a Visual Analogue Scale (VAS) and secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool [iHOT-12]), health-related quality of life (Short Form-12 [SF-12] and Euro-Qol 5 Dimensions [EQ-5D]), and re-operation rate. A multivariable linear regression was used to analyse the change questionnaire scores from baseline to 12 months post-surgery including all 13 prognostic factors as independent variables. A total of 27 re-operation events were analysed at 24 months using a multivariable logistic regression including only the treatment group variable. Results: Of the 154 patients that had VAS scores completed at 12 months, a lower BMI (adjusted mean difference [aMD], 4.48 for a 5-unit decrease in BMI; 95% confidence interval [CI] 0.33–8.63; p = 0.035) was significantly associated with less pain. There was a significant negative association between increasing age and 1-year EQ-5D scores (aMD, − 0.04 for every 10-year increase in age; 95% CI − 0.07 to − 0.006; p = 0.020). The degree of impingement, severity of osteoarthritis, type of procedure, and adjudicated quality of surgery were not significantly associated with improvement across all outcomes at 12 months. Furthermore, there was no significant association between the treatment variable and the incidence of re-operation at 24 months. Conclusion: This study identified that lower BMI and age are predictive of improved pain and health utility scores, respectively, following arthroscopic management of FAI at 12 months post-surgery. These results may be a helpful adjunct in clinical decisions for this patient population when determining candidacy for surgical intervention. Level of evidence: I. [ABSTRACT FROM AUTHOR]

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has affected the hospital experience for patients, visitors, and staff.Objective: To understand clinician perspectives on adaptations to end-of-life care for dying patients and their families during the pandemic.Design: Mixed-methods embedded study. (ClinicalTrials.gov: NCT04602520).Setting: 3 acute care medical units in a tertiary care hospital from 16 March to 1 July 2020.Participants: 45 dying patients, 45 family members, and 45 clinicians.Intervention: During the pandemic, clinicians continued an existing practice of collating personal information about dying patients and "what matters most," eliciting wishes, and implementing acts of compassion.Measurements: Themes from semistructured clinician interviews that were summarized with representative quotations.Results: Many barriers to end-of-life care arose because of infection control practices that mandated visiting restrictions and personal protective equipment, with attendant practical and psychological consequences. During hospitalization, family visits inside or outside the patient's room were possible for 36 patients (80.0%); 13 patients (28.9%) had virtual visits with a relative or friend. At the time of death, 20 patients (44.4%) had a family member at the bedside. Clinicians endeavored to prevent unmarked deaths by adopting advocacy roles to "fill the gap" of absent family and by initiating new and established ways to connect patients and relatives.Limitation: Absence of clinician symptom or wellness metrics; a single-center design.Conclusion: Clinicians expressed their humanity through several intentional practices to preserve personalized, compassionate end-of-life care for dying hospitalized patients during the SARS-CoV-2 pandemic.Primary Funding Source: Canadian Institutes of Health Research and Canadian Critical Care Trials Group Research Coordinator Fund. [ABSTRACT FROM AUTHOR]

Background: Limb salvage with endoprosthetic reconstruction is the current standard practice for the surgical management of lower extremity bone tumors in skeletally mature patients and typically includes tumor resection followed by the functional limb reconstruction with modular metallic and polyethylene endoprosthetic implants. However, owing to the complexity and length of these procedures, as well as the immunocompromised nature of patients treated with chemotherapy, the risk of surgical site infection (SSI) is high. The primary research objective of the Prophylactic Antibiotic Regimens In Tumor Surgery (PARITY) trial is to assess whether a 5-day regimen of post-operative antibiotics decreases the risk of SSI at 1 year post-operatively compared to a 1-day regimen. This article describes the statistical analysis plan for the PARITY trial.Methods/design: The PARITY trial is an ongoing multi-center, blinded parallel two-arm randomized controlled trial (RCT) of 600 participants who have been diagnosed with a primary bone tumor, a soft tissue sarcoma that has invaded the bone or oligometastatic bone disease of the femur or tibia that requires surgical resection and endoprosthetic reconstruction. This article describes the overall analysis principles, including how participants will be included in each analysis, the presentation of results, adjustments for covariates, the primary and secondary outcomes, and their respective analyses. Additionally, we will present the planned sensitivity and sub-group analyses.Discussion: Our prior work has demonstrated (1) high rates of SSI after the treatment of lower extremity tumors by surgical excision and endoprosthetic reconstruction, (2) highly varied opinion and practice among orthopedic oncologists with respect to prophylactic antibiotic regimens, (3) an absence of applicable RCT evidence, (4) extensive support from international investigators to participate in a RCT, and (5) the feasibility of conducting a definitive RCT to evaluate a 5-day regimen of post-operative antibiotics in comparison with a 1-day regimen.Trial Registration: ClinicalTrials.gov NCT01479283 . Registered on 24 November 2011. [ABSTRACT FROM AUTHOR]

Background: Scaling-up and sustaining healthcare interventions can be challenging. Our objective was to describe how the 3 Wishes Project (3WP), a personalized end-of-life intervention, was scaled-up and sustained in an intensive care unit (ICU).Methods: In a longitudinal mixed-methods study from January 12,013 - December 31, 2018, dying patients and families were invited to participate if the probability of patient death was > 95% or after a decision to withdraw life support. A research team member or bedside clinician learned more about each of the patients and their family, then elicited and implemented at least 3 personalized wishes for patients and/or family members. We used a qualitative descriptive approach to analyze interviews and focus groups conducted with 25 clinicians who cared for the enrolled patients. We used descriptive statistics to summarize patient, wish, and clinician characteristics, and analyzed outcome data in quarters using Statistical Process Control charts. The primary outcome was enrollment of terminally ill patients and respective families; the secondary outcome was the number of wishes per patient; tertiary outcomes included wish features and stakeholder involvement.Results: Both qualitative and quantitative analyses suggested a three-phase approach to the scale-up of this intervention during which 369 dying patients were enrolled, having 2039 terminal wishes implemented. From a research project to clinical program to an approach to practice, we documented a three-fold increase in enrolment with a five-fold increase in total wishes implemented, without a change in cost. Beginning as a study, the protocol provided structure; starting gradually enabled frontline staff to experience and recognize the value of acts of compassion for patients, families, and clinicians. The transition to a clinical program was marked by handover from the research staff to bedside staff, whereby project catalysts mentored project champions to create staff partnerships, and family engagement became more intentional. The final transition involved empowering staff to integrate the program as an approach to care, expanding it within and beyond the organization.Conclusions: The 3WP is an end-of-life intervention which was implemented as a study, scaled-up into a clinical program, and sustained by becoming integrated into practice as an approach to care. [ABSTRACT FROM AUTHOR]

Background: Femoroacetabular impingement (FAI) is a condition known to cause hip pain in young adults. Purpose: To evaluate the efficacy of the surgical correction of FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis. In the osteochondroplasty group, cam- and/or pincer-type lesions were resected using fluoroscopic guidance. In the lavage group, the joint was washed out with 3 L of normal saline. Surgeons were instructed to repair the labrum in both groups if it was mechanically unstable once probed, showing visible displacement or chondrolabral separation. The primary outcome was patient-reported pain (using the 100-point visual analog scale [VAS]) at 12 months. Secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol–5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events at 24 months. Results: At 12 months, there was no difference in pain (VAS) between the groups (mean difference [MD], 0.11 [95% CI, –7.22 to 7.45]; P =.98). Also, 88.3% (189/214) of participants had a labral tear, of which 60.3% were repaired. For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, –5.03 [95% CI, −10.40 to −0.03]; P =.049). By 24 months, there were significantly fewer reoperations reported in the osteochondroplasty group (8/105) than the lavage group (19/104) (odds ratio, 0.37 [95% CI, 0.15-0.89]; P =.026). The primary reasons for a reoperation included hip pain (15/27; 55.6%) and a reinjury of the labrum (11/27; 40.7%). Conclusion: Both the osteochondroplasty and the lavage groups with or without labral repair for FAI had significantly improved pain or function significantly at 1 year. By 2 years, the reoperation rate was significantly lower in the osteochondroplasty group. Registration: NCT01623843 (ClinicalTrials.gov identifier) [ABSTRACT FROM AUTHOR]

Background: Postoperative atrial fibrillation (POAF) is associated with clinically significant short- and long-term complications after noncardiac surgery. Our aim was to describe the incidence of clinically important POAF after noncardiac surgery and establish the prognostic value of N-terminal pro-brain-type natriuretic peptide (NT-proBNP) in this context.Methods: The Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Study was a prospective cohort study involving patients aged 45 years and older who had inpatient noncardiac surgery that was performed between August 2007 and November 2013. We determined 30-day incidence of clinically important POAF (i.e., resulting in angina, congestive heart failure, symptomatic hypotension or requiring treatment) using logistic regression models to analyze the association between preoperative NT-proBNP and POAF.Results: In 37 664 patients with no history of atrial fibrillation, we found that the incidence of POAF was 1.0% (95% confidence interval [CI] 0.9%-1.1%; 369 events); 3.2% (95% CI 2.3%-4.4%) in patients undergoing major thoracic surgery, 1.3% (95% CI 1.2%-1.5%) in patients undergoing major nonthoracic surgery and 0.2% (95% CI 0.1%-0.3%) in patients undergoing low-risk surgery. In a subgroup of 9789 patients with preoperative NT-proBNP measurements, the biomarker improved the prediction of POAF risk over conventional prognostic factors (likelihood ratio test p < 0.001; fraction of new information from NT-proBNP was 16%). Compared with a reference NT-proBNP measurement set at 100 ng/L, adjusted odds ratios for the occurrence of POAF were 1.31 (95% CI 1.15-1.49) at 200 ng/L, 2.07 (95% CI 1.27-3.36) at 1500 ng/L and 2.39 (95% CI 1.26-4.51) at 3000 ng/L.Interpretation: We determined that the incidence of clinically important POAF after noncardiac surgery was 1.0%. We also found that preoperative NT-proBNP levels were associated with POAF independent of established prognostic factors. Trial registration: ClinicalTrials.gov, no. NCT00512109. [ABSTRACT FROM AUTHOR]

Introduction Ventilator-associated pneumonia (VAP) is a common healthcare-associated infection in the intensive care unit (ICU). Probiotics are defined as live microorganisms that may confer health benefits when ingested. Prior randomised trials suggest that probiotics may prevent infections such as VAP and Clostridioides difficile–associated diarrhoea (CDAD). PROSPECT (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial) is a multicentre, double-blinded, randomised controlled trial comparing the efficacy of the probiotic Lactobacillus rhamnosus GG with usual care versus usual care without probiotics in preventing VAP and other clinically important outcomes in critically ill patients admitted to the ICU. Methods and analysis The objective of E-PROSPECT is to determine the incremental cost-effectiveness of L. rhamnosus GG plus usual care versus usual care without probiotics in critically ill patients. E-PROSPECT will be performed from the public healthcare payer’s perspective over a time horizon from ICU admission to hospital discharge. We will determine probabilities of in-ICU and in-hospital events from all patients alongside PROSPECT. We will retrieve unit costs for each resource use item using jurisdiction-specific public databases, supplemented by individual site unit costs if such databases are unavailable. Direct costs will include medications, personnel costs, radiology/laboratory testing, operative/non-operative procedures and per-day hospital ‘hoteling’ costs not otherwise encompassed. The primary outcome is the incremental cost per VAP prevented between the two treatment groups. Other clinical events such as CDAD, antibiotic-associated diarrhoea and in-hospital mortality will be included as secondary outcomes. We will perform pre-specified subgroup analyses (medical/surgical/trauma; age; frailty status; antibiotic use; prevalent vs no prevalent pneumonia) and probabilistic sensitivity analyses for VAP, then generate confidence intervals using the nonparametric bootstrapping approach. Ethics and dissemination Study approval for EPROSPECT was granted by the Hamilton Integrated Research Ethics Board of McMaster University on 29 July 2019. Informed consent was obtained from the patient or substitute decision-maker in PROSPECT. The findings of this study will be published in peer-reviewed journals. [ABSTRACT FROM AUTHOR]

Background: Femoroacetabular impingement (FAI) is an important cause of hip pain in young and active individuals and occurs as a result of size and shape mismatch between the femoral head and acetabulum. Open physes in children can make hips more susceptible to injury, and high impact forces have been suggested to affect the developing femur. The diagnosis of FAI has recently risen, especially within adolescent populations, and there is an increasing trend towards year-round participation in sports with early specialization. The PREVIEW study is an international longitudinal study designed to determine the association between sport specialization in adolescence and the development of hip impingement.Methods: This is a multicentre prospective cohort study evaluating 200 participants between the ages of 12-14 that include sport specialists at the moderate to vigorous physical activity (MVPA) level and non-sport specialists at any activity level. We will monitor physical activity levels of all participants using an activity log and a wrist-mounted activity tracker, with synced data collected every 3 months during the study period. In addition, participants will be evaluated clinically at 6, 12, and 18 months and radiographically at the time of enrolment and 24 months. The primary outcome is the incidence of FAI between groups at 2 years, determined via MRI. Secondary outcomes include hip function and health-related quality of life between subjects diagnosed with FAI versus no FAI at 2 years, as determined by the Hip Outcome Score (HOS) and Pediatric Quality of Life (PedsQL) questionnaires.Discussion: It is important to mitigate the risk of developing hip deformities at a young age. Our proposed prospective evaluation of the impact of sport activity and hip development is relevant in this era of early sport specialization in youth. Improving the understanding between sport specialization and the development of pre-arthritic hip disease such as FAI can lead to the development of training protocols that protect the millions of adolescents involved in sports annually.Trial Registration: PREVIEW is registered with clinicaltrials.gov (NCT03891563). [ABSTRACT FROM AUTHOR]

Background: Preliminary data suggest that preoperative N-terminal pro-B-type natriuretic peptide (NT-proBNP) may improve risk prediction in patients undergoing noncardiac surgery.Objective: To determine whether preoperative NT-proBNP has additional predictive value beyond a clinical risk score for the composite of vascular death and myocardial injury after noncardiac surgery (MINS) within 30 days after surgery.Design: Prospective cohort study.Setting: 16 hospitals in 9 countries.Patients: 10 402 patients aged 45 years or older having inpatient noncardiac surgery.Measurements: All patients had NT-proBNP levels measured before surgery and troponin T levels measured daily for up to 3 days after surgery.Results: In multivariable analyses, compared with preoperative NT-proBNP values less than 100 pg/mL (the reference group), those of 100 to less than 200 pg/mL, 200 to less than 1500 pg/mL, and 1500 pg/mL or greater were associated with adjusted hazard ratios of 2.27 (95% CI, 1.90 to 2.70), 3.63 (CI, 3.13 to 4.21), and 5.82 (CI, 4.81 to 7.05) and corresponding incidences of the primary outcome of 12.3% (226 of 1843), 20.8% (542 of 2608), and 37.5% (223 of 595), respectively. Adding NT-proBNP thresholds to clinical stratification (that is, the Revised Cardiac Risk Index [RCRI]) resulted in a net absolute reclassification improvement of 258 per 1000 patients. Preoperative NT-proBNP values were also statistically significantly associated with 30-day all-cause mortality (less than 100 pg/mL [incidence, 0.3%], 100 to less than 200 pg/mL [incidence, 0.7%], 200 to less than 1500 pg/mL [incidence, 1.4%], and 1500 pg/mL or greater [incidence, 4.0%]).Limitation: External validation of the identified NT-proBNP thresholds in other cohorts would reinforce our findings.Conclusion: Preoperative NT-proBNP is strongly associated with vascular death and MINS within 30 days after noncardiac surgery and improves cardiac risk prediction in addition to the RCRI.Primary Funding Source: Canadian Institutes of Health Research. [ABSTRACT FROM AUTHOR]

Background: The 3 Wishes Project (3WP) is an end-of-life program that aims to honor the dignity of dying patients by creating meaningful patient- and family-centered memories while promoting humanistic interprofessional care.Objective: To determine whether this palliative intervention could be successfully implemented-defined as demonstrating value, transferability, affordability, and sustainability-beyond the intensive care unit in which it was created.Design: Mixed-methods formative program evaluation. (ClinicalTrials.gov: NCT04147169).Setting: 4 North American intensive care units.Participants: Dying patients, their families, clinicians, hospital managers, and administrators.Intervention: Wishes from dying patients, family members, and clinicians were elicited and implemented.Measurements: Patient characteristics and processes of care; the number, type, and cost of each wish; and semistructured interviews and focus groups with family members, clinicians, and managers.Results: A total of 730 patients were enrolled, and 3407 wishes were elicited. Qualitative data were gathered from 75 family members, 72 clinicians, and 20 managers or hospital administrators. Value included intentional comforting of families as they honored the lives and legacies of their loved ones while inspiring compassionate clinical care. Factors promoting transferability included family appreciation and a collaborative intensive care unit culture committed to dignity-conserving end-of-life care. Staff participation evolved from passive support to professional agency. Program initiation required minimal investment for reusable materials; thereafter, the mean cost was $5.19 (SD, $17.14) per wish. Sustainability was demonstrated by the continuation of 3WP at each site after study completion.Limitation: This descriptive formative evaluation describes tertiary care center-specific experiences rather than aiming for generalizability to all jurisdictions.Conclusion: The 3WP is a transferrable, affordable, and sustainable program that provides value to dying patients, their families, clinicians, and institutions.Primary Funding Source: Greenwall Foundation. [ABSTRACT FROM AUTHOR]

Background: Critical care research coordinators implement study protocols in intensive care units, yet little is known about their experiences. Objective: To identify the responsibilities, stressors, motivators, and job satisfaction of critical care research coordinators in Canada. Methods: Responses to a self-administered survey were collected in order to identify and understand factors that motivate and stress research coordinators and enhance their job satisfaction. Items were generated in 5 domains (demographics, job responsibilities, stressors, motivators, and satisfaction). Face validity pretesting was conducted and clinical sensibility was evaluated. Items were rated on 5-point Likert scales. Descriptive analyses were used to report results. Results: The response rate was 78% (66 of 85). Most critical care research coordinators (71%) were employed full time; they were engaged in 9 studies (7 academic, 2 industry); and 49% were nurses. Of 30 work responsibilities, the most frequently cited were submitting ethics applications (89%), performing data entry (89%), and attending meetings (87%). Highest-rated stressors were unrealistic workload and weekend/holiday screening; highest-rated motivators were a positive work environment and team spirit. Overall, 26% were "very satisfied" and 53% were "satisfied" with their jobs. Conclusions: Critical care research coordinators in Canada indicate that, despite significant work responsibilities, they are satisfied with their jobs thanks to positive work environments and team spirit. [ABSTRACT FROM AUTHOR]

Introduction Ventilator-associated pneumonia (VAP) is the most common healthcare-associated infection in critically ill patients. Prior studies suggest that probiotics may reduce VAP and other infections in critically ill patients; however, most previous randomised trials were small, single centre studies. The Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT) aims to determine the impact of the probiotic Lactobacillus rhamnosus GG on VAP and other clinically important outcomes in critically ill adults. Methods PROSPECT is a multicentre, concealed, randomised, stratified, blinded, controlled trial in patients ≥18 years old, anticipated to be mechanically ventilated ≥72 hours, in intensive care units (ICUs) in Canada, the USA and Saudi Arabia. Patients receive either 1×1010 colony forming units of L. rhamnosus GG twice daily or an identical appearing placebo. Those at increased risk of probiotic infection are excluded. The primary outcome is VAP. Secondary outcomes are other ICU-acquired infections including Clostridioides difficile infection, diarrhoea (including antibiotic-associated diarrhoea), antimicrobial use, ICU and hospital length of stay and mortality. The planned sample size of 2650 patients is based on an estimated 15% VAP rate and will provide 80% power to detect a 25% relative risk reduction. Ethics and dissemination This protocol and statistical analysis plan outlines the methodology, primary and secondary analyses, sensitivity analyses and subgroup analyses. PROSPECT is approved by Health Canada (#9427-M1133-45C), the research ethics boards of all participating hospitals and Public Health Ontario. Results will be disseminated via academic channels (peer reviewed journal publications, professional healthcare fora including international conferences) and conventional and social media. The results of PROSPECT will inform practice guidelines worldwide. Introduction Human papillomaviruses (HPVs) are responsible for one-third of all cancers caused by infections. Most HPV studies focus on chronic infections and cancers, and we know little about the early stages of the infection. Our main objective is to better understand the course and natural history of cervical HPV infections in healthy, unvaccinated and vaccinated, young women, by characterising the dynamics of various infection-related populations (virus, epithelial cells, vaginal microbiota and immune effectors). Another objective is to analyse HPV diversity within hosts, and in the study population, in relation to co-factors (lifestyle characteristics, vaccination status, vaginal microbiota, human genetics). Methods and analysis The PAPCLEAR study is a single center longitudinal study following 150 women, aged 18-25 years, for up to 2 years. Visits occur every 2 or 4 months (depending on HPV status) during which several variables are measured, such as behaviours (via questionnaires), vaginal pH, HPV presence and viral load (via qPCR), local concentrations of cytokines (via MesoScale Discovery technology) and immune cells (via flow cytometry). Additional analyses are outsourced, such as titration of circulating anti-HPV antibodies, vaginal microbiota sequencing (16S and ITS1 loci) and human genotyping. To increase the statistical power of the epidemiological arm of the study, an additional 150 women are screened cross-sectionally. Finally, to maximise the resolution of the time series, participants are asked to perform weekly self-samples at home. Statistical analyses will involve classical tools in epidemiology, genomics and virus kinetics, and will be performed or coordinated by the Centre National de la Recherche Scientifique (CNRS) in Montpellier. Ethics and dissemination This study has been approved by the Comité de Protection des Personnes Sud Méditerranée I (reference number 2016-A00712-49); by the Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le domaine de la Santé (reference number 16.504); by the Commission Nationale Informatique et Libertés (reference number MMS/ABD/ AR1612278, decision number DR-2016-488) and by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (reference 20160072000007). Results will be published in preprint servers, peer-reviewed journals and disseminated through conferences. [ABSTRACT FROM AUTHOR]