Retraction speed and chronic poststernotomy pain: A randomized controlled trial.

OBJECTIVES: Approximately 30% of patients develop chronic poststernotomy pain (CPSP) following cardiac surgery with sternal retraction. Risk factors have been described but no causal determinants identified. Investigators hypothesized that opening the sternum slowly would impart less force (and thereby less nerve/tissue damage) and translate to a reduced incidence of CPSP. The main objectives were to determine whether or not slower sternal retraction would reduce the incidence of CPSP and improve health-related quality of life. METHODS: Patients undergoing coronary artery bypass graft surgery were recruited to this randomized controlled trial. Patients were randomized to slow or standard retraction (ie, sternum opened over 15 minutes vs 30 seconds, respectively). Although the anesthesiologist and surgeon were aware of the randomization, the patients, assessors, and postoperative nursing staff remained blinded. Sternotomy pain and analgesics were measured in hospital. At 3, 6, and 12 months postoperatively, all patients completed the Medical Outcomes Survey Short Form and reported on CPSP and complications requiring rehospitalization. Thirty-day rehospitalizations and mortality were recorded. RESULTS: In total, 326 patients consented to participate and 313 were randomized to slow (n = 159) versus standard retraction (n = 154). No clinically relevant differences were detected in acute pain, analgesic consumption, or the incidence of CPSP or health-related quality of life. Although the slow group had significantly more hospitalizations at 3 and 12 months postoperatively, the reasons were unrelated to retraction speed. No differences were observed in 30-day rehospitalizations or mortality. CONCLUSIONS: All outcomes were consistent with previous reports, but no clinically significant differences were observed with retraction speed.

Benzodiazepine-Free Cardiac Anesthesia for Reduction of Postoperative Delirium (B-Free): A Protocol for a Multi-centre Randomized Cluster Crossover Trial.

Delirium is common after cardiac surgery and is associated with adverse outcomes. Administration of benzodiazepines before and after cardiac surgery is associated with delirium; guidelines recommend minimizing their use. Benzodiazepine administration during cardiac surgery remains common because of its recognized benefits. The Benzodiazepine-Free Cardiac Anesthesia for Reduction of Postoperative Delirium (B-Free) trial is a randomized cluster crossover trial evaluating whether an institutional policy of restricting intraoperative benzodiazepine administration (ie, ≥ 90% of patients do not receive benzodiazepines during cardiac surgery), as compared with a policy of liberal intraoperative benzodiazepine administration (ie, ≥ 90% of patients receive ≥ 0.03 mg/kg midazolam equivalent), reduces delirium. Hospitals performing ≥ 250 cardiac surgeries a year are included if their cardiac anesthesia group agrees to apply both benzodiazepine policies per their randomization, and patients are assessed for postoperative delirium every 12 hours in routine clinical care. Hospitals apply the restricted or liberal benzodiazepine policy during 12 to 18 crossover periods of 4 weeks each. Randomization for all periods takes place in advance of site startup; sites are notified of their allocated policy during the last week of each crossover period. Policies are applied to all patients undergoing cardiac surgery during the trial period. The primary outcome is the incidence of delirium at up to 72 hours after surgery. The B-Free trial will enroll ≥ 18,000 patients undergoing cardiac surgery at 20 hospitals across North America. Delirium is common after cardiac surgery, and benzodiazepines are associated with the occurrence of delirium. The B-Free trial will determine whether an institutional policy restricting the administration of benzodiazepines during cardiac surgery reduces the incidence of delirium after cardiac surgery. Clinicaltrials.gov registration number: NCT03928236 (First registered April 26, 2019).

L'état confusionnel est fréquent après une chirurgie cardiaque et il est associé à des complications. L'administration de benzodiazépines avant et après une chirurgie cardiaque est associée à l'état confusionnel; dans les lignes directrices, on recommande de réduire leur utilisation au minimum. L'administration de benzodiazépines pendant une chirurgie cardiaque demeure fréquente, en raison des leurs bienfaits reconnus. L'essai B-Free (Benzodiazepine-Free Cardiac Anesthesia for Reduction of Postoperative Delirium ou l'anesthésie sans benzodiazépine en contexte de chirurgie cardiaque pour la réduction de l'état confusionnel postopératoire) est un essai à répartition aléatoire par grappes et avec permutation, visant à évaluer si une politique institutionnelle de restriction de l'administration peropératoire de benzodiazépines (c.-à-d. que ≥ 90 % des patients ne reçoivent pas de benzodiazépines durant une chirurgie cardiaque) réduit l'état confusionnel, comparativement à une politique d'administration peropératoire libérale de benzodiazépines (c.-à-d. que ≥ 90 % des patients reçoivent ≥ 0,03 mg/kg d'équivalent du midazolam). Des hôpitaux effectuant au moins 250 chirurgies cardiaques par année sont inclus dans l'essai si leurs équipes d'anesthésie cardiaque acceptent d'appliquer les deux politiques relatives aux benzodiazépines en vertu de la répartition aléatoire et si les patients sont évalués toutes les 12 heures, en ce qui a trait à l'état confusionnel postopératoire, dans le cadre des soins cliniques habituels. Les hôpitaux mettent en œuvre la politique d'administration restreinte ou libérale de benzodiazépines durant 12 à 18 périodes de permutation de 4 semaines chacune. La répartition aléatoire de l'ensemble des périodes a lieu avant le début de l'essai à l'hôpital; les établissements sont avisés de la politique qui leur est attribuée au cours de la dernière semaine de chaque période de permutation. Les politiques sont appliquées à tous les patients qui subissent une chirurgie cardiaque durant la période de l'essai. Le critère d'évaluation principal est l'incidence de l'état confusionnel dans les 72 heures suivant l'intervention chirurgicale. L'étude B-Free inclura au moins 18 000 patients qui subiront une chirurgie cardiaque dans 20 hôpitaux en l'Amérique du Nord. L'état confusionnel est fréquent après une chirurgie cardiaque, et les benzodiazépines sont associées à la survenue de l'état confusionnel. L'essai B-Free permettra de déterminer si une politique institutionnelle de restriction de l'administration de benzodiazépines durant une chirurgie cardiaque réduit l'incidence de l'état confusionnel après une telle chirurgie.Clinicaltrials.gov registration number: NCT03928236 (First registered April 26, 2019).

Are we ready for a sustainable approach? A qualitative study of the readiness of the public health system to provide STI services to the key populations at risk of HIV in Bangladesh.

INTRODUCTION: In Bangladesh, sexually transmitted infection (STI) services are available for all populations in public health facilities. However, STI services for key populations (KPs) at risk of HIV need specifically designed approaches that are predominantly administered to KPs through donor-supported service centers operated by non-government organizations (NGOs) and community-based organisations (CBOs). However, the steady decline in donor funding warrants a sustainable transition of STI services for the KPs into public health facilities. This article aimed to explore the service availability and readiness of public health facilities to provide STI services for the KPs. METHODS: This qualitative study explored the service availability and readiness of public health facilities in three districts of Bangladesh by adapting the Service Availability and Readiness Assessment tool. We conducted 34 in-depth interviews,11 focus group discussions with KPs, and 29 key-informant interviews with healthcare providers, researchers, programme implementers and policy planners, in addition to series of direct observations at the public healthcare facilities. Data were analysed through thematic analysis, and categorised in relation to the WHO building blocks. RESULTS: This study revealed that the public health system was generally not ready to serve the KPs' needs in terms of providing them with quality STI services. The 'service delivery' component, which is the most crucial facet of the public health system, was not ready to provide STI services to KPs. Findings also indicated that health workforce availability was limited in the primary and secondary healthcare layers but adequate in the tertiary layer, but needed to be oriented on providing culturally sensitised treatment. Counseling, an essential component of STI services, was neither ready nor available. However, health information systems and a few other components were partially ready, although this warrants systematic approaches to address these challenges. CONCLUSION: The findings show that public health facilities are yet to be fully ready to render STI services to KPs, especially in terms of service delivery and human and health resources. Therefore, it is not only integral to mobilize communities towards the uptake of public health services, but health systems need to be prepared to cater to their needs.

Methemoglobin as a marker of acute anemic stress in cardiac surgery.

Biological evidence supports plasma methemoglobin as a biomarker for anemia-induced tissue hypoxia. In this translational planned substudy of the multinational randomized controlled transfusion thresholds in cardiac surgery (TRICS-III) trial, which included adults undergoing cardiac surgery requiring cardiopulmonary bypass with a moderate-to-high risk of death, we investigated the relationship between perioperative hemoglobin concentration (Hb) and methemoglobin; and evaluated its association with postoperative outcomes. The primary endpoint was a composite of death, myocardial infarction, stroke, and severe acute kidney injury at 28 days. We observe weak non-linear associations between decreasing Hb and increasing methemoglobin, which were strongest in magnitude at the post-surgical time point. Increased levels of post-surgical methemoglobin were associated with a trend toward an elevated risk for stroke and exploratory neurological outcomes. Our generalizable study demonstrates post-surgical methemoglobin may be a marker of anemia-induced organ injury/dysfunction, and may have utility for guiding personalized approaches to anemia management. Clinicaltrials.gov registration NCT02042898.

Quantifying neurological function in patients undergoing transcatheter aortic valve implantation.

Background: Transcatheter aortic valve implantation (TAVI) is a routine procedure that is often performed on older adults that are high-risk patients with severe aortic stenosis. Patients after TAVI may experience neurological complications. However, there is a lack of objective neurological testing available for patients undergoing cardiac surgery. Objective: This brief communication seeks to explore the use of robotic technology to quantify distinctive patterns of visuospatial, sensorimotor, and cognitive functioning in patients undergoing TAVI. Methods: Patients undergoing TAVI were recruited for this prospective observational study. Prior to their procedure, study participants performed four robotic reaching tasks using the Kinarm robotic system. Patients repeated the assessment three months after their TAVI procedure. Significant changes in overall task score and parameters were determined. Results: Ten patients were recruited and included in this brief report. In a simple reaching task, patients show significant improvement in performance post-TAVI. However, patients do not improve nor worsen in a complex reaching task after TAVI. Similarly, patients demonstrate impairments in both trail making tasks before and after their TAVI procedure. Conclusions: This study captures the variability in neurological functioning in older patients undergoing TAVI. Robotic technology and quantified assessment procedures can be extremely valuable for detecting perioperative neurological impairments in this patient population.

Prolonged mechanical ventilation after cardiac surgery: substudy of the Transfusion Requirements in Cardiac Surgery III trial.

PURPOSE: Prolonged mechanical ventilation (MV) is a major complication following cardiac surgery. We conducted a secondary analysis of the Transfusion Requirements in Cardiac Surgery (TRICTS) III trial to describe MV duration, identify factors associated with prolonged MV, and examine associations of prolonged MV with mortality and complications. METHODS: Four thousand, eight hundred and nine participants undergoing cardiac surgery at 71 hospitals worldwide were included. Prolonged MV was defined based on the Society of Thoracic Surgeons definition as MV lasting 24 hr or longer. Adjusted associations of patient and surgical factors with prolonged MV were examined using multivariable logistic regression. Associations of prolonged MV with complications were assessed using odds ratios, and adjusted associations between prolonged MV and mortality were evaluated using multinomial regression. Associations of shorter durations of MV with survival and complications were explored. RESULTS: Prolonged MV occurred in 15% (725/4,809) of participants. Prolonged MV was associated with surgical factors indicative of complexity, such as previous cardiac surgery, cardiopulmonary bypass duration, and separation attempts; and patient factors such as critical preoperative state, left ventricular impairment, renal failure, and pulmonary hypertension. Prolonged MV was associated with perioperative but not long-term complications. After risk adjustment, prolonged MV was associated with perioperative mortality; its association with long-term mortality among survivors was weaker. Shorter durations of MV were not associated with increased risk of mortality or complications. CONCLUSION: In this substudy of the TRICS III trial, prolonged MV was common after cardiac surgery and was associated with patient and surgical risk factors. Although prolonged MV showed strong associations with perioperative complications and mortality, it was not associated with long-term complications and had weaker association with long-term mortality among survivors. STUDY REGISTRATION: www. CLINICALTRIALS: gov (NCT02042898); registered 23 January 2014. This is a substudy of the Transfusion Requirements in Cardiac Surgery (TRICS) III trial.

RéSUMé: OBJET: La ventilation mécanique (VM) prolongée est une complication majeure après chirurgie cardiaque. Nous avons effectué une analyze secondaire de l'étude TRICS III sur les besoins de transfusion au cours de la chirurgie cardiaque pour décrire la durée de la VM, identifier les facteurs associés à une VM prolongée et examiner les associations de la VM prolongée avec la mortalité et les complications. MéTHODES: Quatre mille huit cent neuf participants subissant une chirurgie cardiaque dans 71 hôpitaux à travers le monde ont été inclus. La VM prolongée a été définie à partir de la définition de la Society of Thoracic Surgeons comme un événement durant 24 heures ou plus. Des associations ajustées de facteurs liés aux patients et à la chirurgie avec la VM prolongée ont été examinées en utilisant une régression logistique multifactorielle. Des associations de la VM prolongée avec des complications ont été évaluées en utilisant des rapports de cotes; les associations ajustées entre VM prolongée et mortalité ont été évaluées au moyen d'une régression multinominale. Les associations d'une VM de plus courte durée avec la survie et des complications ont été explorées. RéSULTATS: La VM prolongée est survenue chez 15 % (725/4 809) des participants. Une VM prolongée a été associée à des facteurs chirurgicaux indicateurs de complexité (comme une chirurgie cardiaque antérieure, la durée de la circulation extracorporelle et les tentatives de débranchement) et à des facteurs liés au patient (comme un état préopératoire critique, une défaillance ventriculaire gauche, une insuffisance rénale et une hypertension pulmonaire). La VM prolongée a été associée à des complications périopératoires, mais pas à des complications à long terme. Après ajustement pour le risque, la VM prolongée a été associée à la mortalité périopératoire; son association avec la mortalité à long terme des survivants a été plus faible. Les durées plus courtes de VM n'ont pas été associées à une augmentation du risque de mortalité ou à des complications. CONCLUSION: Dans cette étude auxiliaire de l'essai TRICS III, la VM prolongée a été fréquente après chirurgie cardiaque et a été associée à des facteurs de risque liés au patient et à la chirurgie. Bien que la VM prolongée ait présenté de fortes associations avec les complications périopératoires et la mortalité, elle n'a pas été associée avec des complications à long terme et était plus faiblement associée à la mortalité à long terme parmi les survivants. ENREGISTREMENT DE L'éTUDE: www.ClinicalTrials.gov (NCT02042898); enregistrée le 23 janvier 2014. Il s'agit d'une étude auxiliaire de l'étude TRICS III sur les besoins de transfusion en chirurgie cardiaque.

Restrictive versus liberal transfusion in patients with diabetes undergoing cardiac surgery: An open-label, randomized, blinded outcome evaluation trial.

AIM: To characterize the association between diabetes and transfusion and clinical outcomes in cardiac surgery, and to evaluate whether restrictive transfusion thresholds are harmful in these patients. MATERIALS AND METHODS: The multinational, open-label, randomized controlled TRICS-III trial assessed a restrictive transfusion strategy (haemoglobin [Hb] transfusion threshold <75 g/L) compared with a liberal strategy (Hb <95 g/L for operating room or intensive care unit; or <85 g/L for ward) in patients undergoing cardiac surgery on cardiopulmonary bypass with a moderate-to-high risk of death (EuroSCORE ≥6). Diabetes status was collected preoperatively. The primary composite outcome was all-cause death, stroke, myocardial infarction, and new-onset renal failure requiring dialysis at 6 months. Secondary outcomes included components of the composite outcome at 6 months, and transfusion and clinical outcomes at 28 days. RESULTS: Of the 5092 patients analysed, 1396 (27.4%) had diabetes (restrictive, n = 679; liberal, n = 717). Patients with diabetes had more cardiovascular disease than patients without diabetes. Neither the presence of diabetes (OR [95% CI] 1.10 [0.93-1.31]) nor the restrictive strategy increased the risk for the primary composite outcome (diabetes OR [95% CI] 1.04 [0.68-1.59] vs. no diabetes OR 1.02 [0.85-1.22]; Pinteraction  = .92). In patients with versus without diabetes, a restrictive transfusion strategy was more effective at reducing red blood cell transfusion (diabetes OR [95% CI] 0.28 [0.21-0.36]; no diabetes OR [95% CI] 0.40 [0.35-0.47]; Pinteraction  = .04). CONCLUSIONS: The presence of diabetes did not modify the effect of a restrictive transfusion strategy on the primary composite outcome, but improved its efficacy on red cell transfusion. Restrictive transfusion triggers are safe and effective in patients with diabetes undergoing cardiac surgery.

Effect of Continuous Electrocardiogram Monitoring on Detection of Undiagnosed Atrial Fibrillation After Hospitalization for Cardiac Surgery: A Randomized Clinical Trial.

Importance: Postoperative atrial fibrillation (POAF) occurring after cardiac surgery is associated with adverse outcomes. Whether POAF persists beyond discharge is not well defined. Objective: To determine whether continuous cardiac rhythm monitoring enhances detection of POAF among cardiac surgical patients during the first 30 days after hospital discharge compared with usual care. Design, Setting, and Participants: This study is an investigator-initiated, open-label, multicenter, randomized clinical trial conducted at 10 Canadian centers. Enrollment spanned from March 2017 to March 2020, with follow-up through September 11, 2020. As a result of the COVID-19 pandemic, enrollment stopped on July 17, 2020, at which point 85% of the proposed sample size was enrolled. Cardiac surgical patients with CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes, prior stroke or transient ischemic attack, vascular disease, age 65-74 years, female sex) score greater than or equal to 4 or greater than or equal to 2 with risk factors for POAF, no history of preoperative AF, and POAF lasting less than 24 hours during hospitalization were enrolled. Interventions: The intervention group underwent continuous cardiac rhythm monitoring with wearable, patch-based monitors for 30 days after randomization. Monitoring was not mandated in the usual care group within 30 days after randomization. Main Outcomes and Measures: The primary outcome was cumulative AF and/or atrial flutter lasting 6 minutes or longer detected by continuous cardiac rhythm monitoring or by a 12-lead electrocardiogram within 30 days of randomization. Prespecified secondary outcomes included cumulative AF lasting 6 hours or longer and 24 hours or longer within 30 days of randomization, death, myocardial infarction, ischemic stroke, non-central nervous system thromboembolism, major bleeding, and oral anticoagulation prescription. Results: Of the 336 patients randomized (163 patients in the intervention group and 173 patients in the usual care group; mean [SD] age, 67.4 [8.1] years; 73 women [21.7%]; median [interquartile range] CHA2DS2-VASc score, 4.0 [3.0-4.0] points), 307 (91.4%) completed the trial. In the intent-to-treat analysis, the primary end point occurred in 32 patients (19.6%) in the intervention group vs 3 patients (1.7%) in the usual care group (absolute difference, 17.9%; 95% CI, 11.5%-24.3%; P < .001). AF lasting 6 hours or longer was detected in 14 patients (8.6%) in the intervention group vs 0 patients in the usual care group (absolute difference, 8.6%; 95% CI, 4.3%-12.9%; P < .001). Conclusions and Relevance: In post-cardiac surgical patients at high risk of stroke, no preoperative AF history, and AF lasting less than 24 hours during hospitalization, continuous monitoring revealed a significant increase in the rate of POAF after discharge that would otherwise not be detected by usual care. Studies are needed to examine whether these patients will benefit from oral anticoagulation therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT02793895.

Cognitive Outcomes after DEXmedetomidine sedation in cardiac surgery: CODEX randomised controlled trial protocol.

INTRODUCTION: Older patients undergoing cardiac surgery carry the highest risk for developing major postoperative neurocognitive disorder (postoperative NCD or P-NCD) with up to 25% incidence 3 months after surgery. P-NCD is associated with significant morbidity, mortality, loss of independence, premature retirement and increased healthcare costs. This multicentre randomised trial is investigating the efficacy of postoperative dexmedetomidine sedation in reducing the incidence of major P-NCD after cardiac surgery compared with standard protocols. CODEX will be the largest interventional trial with major P-NCD as the primary outcome. METHODS AND ANALYSIS: CODEX is recruiting patients ≥60 years old, undergoing elective cardiac surgery and without pre-existing major cognitive dysfunction or dementia. Eligible participants are randomised to receive postoperative dexmedetomidine or standard institutional sedation protocols in the intensive care unit. Baseline preoperative cognitive function is assessed with the computer-based Cogstate Brief Battery. The primary outcome, major P-NCD, 3 months after surgery is defined as a decrease in cognitive function ≥1.96 SD below age-matched, non-operative controls. Secondary outcomes include delirium, major P-NCD at 6/12 months, depressive symptoms, mild P-NCD and quality of surgical recovery at 3/6/12 months. The specific diagnostic criteria used in this protocol are consistent with the recommendations for clinical assessment and management of NCD from the Nomenclature Consensus Working Group on perioperative cognitive changes. Intention-to-treat analysis will compare major P-NCD at 3 months between study groups. ETHICS AND DISSEMINATION: CODEX was approved by Sunnybrook Health Sciences Centre Research Ethics Board (REB) (Project ID 1743). This will be the first multicentre, randomised controlled trial to assess the efficacy of a pharmacological intervention to reduce the incidence of major P-NCD after cardiac surgery in patients ≥60 years old. Dissemination of the study results will include briefings of key findings and interpretation, conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT04289142.

Quantified pre-operative neurological dysfunction predicts outcome after coronary artery bypass surgery.

AIMS: Patients undergoing coronary artery bypass grafting (CABG) surgery may experience neurological impairment. We examined whether intraoperative regional cerebral oxygen saturation (rSO2) and neurological dysfunction prior to surgery, measured by robotic technology, are important predictors of post-operative performance following CABG surgery. METHODS: Adult patients undergoing CABG surgery were recruited for this single-center prospective observational study. Intraoperative rSO2 was captured using the FORESIGHT cerebral oximeter. Neurological assessment was performed pre-operatively and 3 months following surgery using robotic technology and a standardized pen-and-paper assessment. Linear regression models were generated to determine the predictive ability of both intraoperative rSO2 and pre-operative performance on post-operative neurological outcome. RESULTS: Forty patients had complete data available for analysis. Quantified pre-operative performance accounted for a significantly larger amount of variance in post-operative outcome compared to intraoperative rSO2. In particular, pre-operative scoring on a cognitive visuospatial task accounted for 82.2% of variance in post-operative performance (b = 0.937, t(37) = 12.98, p = 1.28e-5). DISCUSSION: Our results suggest that pre-operative performance is a stronger indicator of post-operative neurological outcome than intraoperative rSO2, and should be included as an important variable when elucidating the relationship between cerebral oxygen levels and post-operative neurological impairment. Rigorous neurological assessment prior to surgery can provide valuable information about each individual patient's path to recovery. CONCLUSION: Using robotic technology, quantified neurological impairment prior to CABG surgery may better predict post-operative neurological outcomes, compared to intraoperative rSO2 values.

Road to recovery: a study protocol quantifying neurological outcome in cardiac surgery patients and the role of cerebral oximetry.

INTRODUCTION: Patients undergoing cardiac surgery may experience both short-term and long-term postoperative neurological problems. However, the underlying cause of this impairment is unclear. Regional cerebral oxygen saturation (rSO2) levels may play a role in the development of acute dysfunction, known as postoperative delirium, in addition to longer term outcomes after cardiac surgery. Yet the degree of impairment has been difficult to define, partly due to subjective methods of assessments. This study aims to fill this knowledge gap by determining the relationship between rSO2, postoperative delirium and long-term neurological outcome after cardiac surgery using quantitative robotic technology. METHODS AND ANALYSIS: 95 patients scheduled for elective cardiac surgery will be recruited for this single-centre prospective observational study. Patients will be assessed before as well as 3 and 12 months after their surgery using the Kinarm End-Point Lab and standardised tasks. Intraoperatively, rSO2 and other haemodynamic data will be collected for the duration of the procedure. Following their operation, patients will also be screened daily for delirium during their hospital stay. ETHICS AND DISSEMINATION: This study has been approved by the Health Sciences Research Ethics Board at Queen's University (DMED-1672-14). The results of this study will be published in a peer-review journal and presented at international and/or national conferences as poster or oral presentations. Participants wishing to know the results of this study will be contacted directly on data publication. TRIAL REGISTRATION NUMBER: NCT04081649.

Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery: The FIBRES Randomized Clinical Trial.

IMPORTANCE: Excessive bleeding is a common complication of cardiac surgery. An important cause of bleeding is acquired hypofibrinogenemia (fibrinogen level <1.5-2.0 g/L), for which guidelines recommend fibrinogen replacement with cryoprecipitate or fibrinogen concentrate. The 2 products have important differences, but comparative clinical data are lacking. OBJECTIVE: To determine if fibrinogen concentrate is noninferior to cryoprecipitate for treatment of bleeding related to hypofibrinogenemia after cardiac surgery. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial at 11 Canadian hospitals enrolling adult patients experiencing clinically significant bleeding and hypofibrinogenemia after cardiac surgery (from February 10, 2017, to November 1, 2018). Final 28-day follow-up visit was completed on November 28, 2018. INTERVENTIONS: Fibrinogen concentrate (4 g; n = 415) or cryoprecipitate (10 units; n = 412) for each ordered dose within 24 hours after cardiopulmonary bypass. MAIN OUTCOMES AND MEASURES: Primary outcome was blood components (red blood cells, platelets, plasma) administered during 24 hours post bypass. A 2-sample, 1-sided test for the ratio of the mean number of units was conducted to evaluate noninferiority (threshold for noninferiority ratio, <1.2). RESULTS: Of 827 randomized patients, 735 (372 fibrinogen concentrate, 363 cryoprecipitate) were treated and included in the primary analysis (median age, 64 [interquartile range, 53-72] years; 30% women; 72% underwent complex operations; 95% moderate to severe bleeding; and pretreatment fibrinogen level, 1.6 [interquartile range, 1.3-1.9] g/L). The trial met the a priori stopping criterion for noninferiority at the interim analysis after 827 of planned 1200 patients were randomized. Mean 24-hour postbypass allogeneic transfusions were 16.3 (95% CI, 14.9 to 17.8) units in the fibrinogen concentrate group and 17.0 (95% CI, 15.6 to 18.6) units in the cryoprecipitate group (ratio, 0.96 [1-sided 97.5% CI, -∞ to 1.09; P < .001 for noninferiority] [2-sided 95% CI, 0.84 to 1.09; P = .50 for superiority]). Thromboembolic events occurred in 26 patients (7.0%) in the fibrinogen concentrate group and 35 patients (9.6%) in the cryoprecipitate group. CONCLUSIONS AND RELEVANCE: In patients undergoing cardiac surgery who develop clinically significant bleeding and hypofibrinogenemia after cardiopulmonary bypass, fibrinogen concentrate is noninferior to cryoprecipitate with regard to number of blood components transfused in a 24-hour period post bypass. Use of fibrinogen concentrate may be considered for management of bleeding in patients with acquired hypofibrinogenemia in cardiac surgery. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03037424.

The willingness to receive sexually transmitted infection services from public healthcare facilities among key populations at risk for human immunodeficiency virus infection in Bangladesh: A qualitative study.

BACKGROUND: In Bangladesh, community-based and peer-led prevention interventions for human immunodeficiency virus infection are provided to key populations (KPs) by drop-in centers (DICs), which are primarily supported by external donors. This intervention approach was adopted because public healthcare facilities were reportedly insensitive to the needs and culture of KPs, particularly with regard to the provision of sexually transmitted infection (STI) services. Nonetheless, in the absence of external funding, STI services need to be integrated into public healthcare systems. METHODS: A qualitative study was conducted in 2017 to understand the willingness of KPs to uptake the STI services of public healthcare facilities. Data were collected based on 34 in-depth interviews, 11 focus group discussions, and 9 key informant interviews. The social-ecological theoretical framework was used to analyze the data thematically and contextually. RESULTS: Most participants were either resistant or reluctant to uptake STI services from public healthcare facilities because of their previous firsthand experiences (e.g., disrespectful and judgmental attitudes and behaviors), perceived discrimination, anticipatory fear, and a lack of privacy. Very few participants who had visited these facilities to receive STI services were motivated to revisit them. Nevertheless, they emphasized their comfort in DICs over public healthcare facilities. Thus, it appears that KPs can be situated along a care-seeking continuum (i.e., resistance to complete willingness). Unless policymakers understand the context and reasons that underlie their movement along this continuum, it would be difficult to encourage KPs to access STI services from public healthcare facilities. CONCLUSION: KPs' willingness to uptake the STI services of public healthcare facilities depends not only on individual and community experiences but also on the nexus between socio-structural factors and health inequalities. Community mobilization and training about the needs and culture of KPs for healthcare professionals are essential. Therefore, addressal of a wide range of structural factors is required to motivate KPs into seeking STI services from public healthcare facilities.

Reporting preclinical anesthesia study (REPEAT): Evaluating the quality of reporting in the preclinical anesthesiology literature.

Poor reporting quality may contribute to irreproducibility of results and failed 'bench-to-bedside' translation. Consequently, guidelines have been developed to improve the complete and transparent reporting of in vivo preclinical studies. To examine the impact of such guidelines on core methodological and analytical reporting items in the preclinical anesthesiology literature, we sampled a cohort of studies. Preclinical in vivo studies published in Anesthesiology, Anesthesia & Analgesia, Anaesthesia, and the British Journal of Anaesthesia (2008-2009, 2014-2016) were identified. Data was extracted independently and in duplicate. Reporting completeness was assessed using the National Institutes of Health Principles and Guidelines for Reporting Preclinical Research. Risk ratios were used for comparative analyses. Of 7615 screened articles, 604 met our inclusion criteria and included experiments reporting on 52 490 animals. The most common topic of investigation was pain and analgesia (30%), rodents were most frequently used (77%), and studies were most commonly conducted in the United States (36%). Use of preclinical reporting guidelines was listed in 10% of applicable articles. A minority of studies fully reported on replicates (0.3%), randomization (10%), blinding (12%), sample-size estimation (3%), and inclusion/exclusion criteria (5%). Statistics were well reported (81%). Comparative analysis demonstrated few differences in reporting rigor between journals, including those that endorsed reporting guidelines. Principal items of study design were infrequently reported, with few differences between journals. Methods to improve implementation and adherence to community-based reporting guidelines may be necessary to increase transparent and consistent reporting in the preclinical anesthesiology literature.

Knowledge retention after focused cardiac ultrasound training: a prospective cohort pilot study / Retenção do conhecimento após treinamento de ultrassonografia cardíaca focada: estudo-piloto prospectivo de coorte

Abstract Background and objectives: Focused Cardiac Ultrasound (FoCUS) has proven instrumental in guiding anesthesiologists' clinical decision-making process. Training residents to perform and interpret FoCUS is both feasible and effective. However, the degree of knowledge retention after FoCUS training remains a subject of debate. We sought to provide a description of our 4-week FoCUS curriculum, and to assess the knowledge retention among anesthesia residents at 6 months after FoCUS rotation. Methods: A prospective analysis involving eleven senior anesthesia residents was carried out. At end of FoCUS Rotation (EOR) participants completed a questionnaire (evaluating the number of scans completed and residents' self-rated knowledge and comfort level with FoCUS), and a multiple-choice FoCUS exam comprised of written- and video-based questions. Six months later, participants completed a follow-up questionnaire and a similar exam. Self-rated knowledge and exam scores were compared at EOR and after 6 months. Spearman correlations were conducted to test the relationship between number of scans completed and exam scores, perceived knowledge and exam scores, and number of scans and perceived knowledge. Results: Mean exam scores (out of 50) were 44.1 at EOR and 43 at the 6-month follow-up. Residents had significantly higher perceived knowledge (out of 10) at EOR (8.0) than at the 6-month follow-up (5.5), p = 0.003. At the EOR, all trainees felt comfortable using FoCUS, and at 6 months 10/11 still felt comfortable. All the trainees had used FoCUS in their clinical practice after EOR, and the most cited reason for not using FoCUS more frequently was the lack of perceived clinical need. A strong and statistically significant (rho = 0.804, p = 0.005) correlation between number of scans completed during the FoCUS rotation and 6-month follow-up perceived knowledge was observed. Conclusion: Four weeks of intensive FoCUS training results in adequate knowledge acquisition and 6-month knowledge retention.

Resumo Justificativa e objetivos: A ultrassonografia cardíaca no local de atendimento (USCLA) provou ser importante para orientar o processo de tomada de decisão clínica dos anestesiologistas. Treinar os residentes para fazer e interpretar uma USCLA é viável e eficaz. No entanto, o grau de retenção do conhecimento após o treinamento permanece um assunto de debate. Procuramos fornecer uma descrição do currículo de quatro semanas do treinamento de USCLA e avaliar a retenção do conhecimento entre os residentes de anestesia seis meses após a rotação em USCLA. Métodos: Uma análise prospectiva foi realizada com 11 residentes seniores de anestesia. Ao final da rotação em USCLA, os participantes preencheram um questionário (avaliando o número de exames ultrassonográficos concluídos, o conhecimento adquirido e o nível de conforto dos residentes com a USCLA) e fizeram um exame de múltipla escolha para USCLA, composto por perguntas escritas e baseadas em vídeo. Seis meses depois, os participantes preencheram um questionário de acompanhamento e um exame similar. A autoavaliação do conhecimento e os escores do exame foram comparados no final da rotação e após seis meses. Correlações de Spearman foram usadas para testar a relação entre o número de exames concluídos e os escores dos exames, o conhecimento percebido, os escores dos exames, o número de exames e o conhecimento percebido. Resultados: Os escores médios dos exames (50) foram: 44,1 no final da rotação e 43 após seis meses. Os residentes tiveram conhecimento percebido significativamente maior (10) no final da rotação (8,0) que após seis meses (5,5), p = 0,003. No final da rotação, todos os residentes se sentiram confortáveis usando o aparelho de USCLA e, aos seis meses, 10/11 ainda se sentiam confortáveis. Todos os residentes haviam usado o USCLA em sua prática clínica após o final da rotação e a razão mais citada para não usar o USCLA com mais frequência foi a falta de necessidade clínica percebida. Uma correlação forte e estatisticamente significativa (rho = 0,804, p = 0,005) foi observada entre o número de exames realizados durante a rotação em USCLA e o conhecimento percebido em seis meses de seguimento. Conclusão: Quatro semanas de treinamento intensivo de USCLA resultaram em aquisição e retenção adequadas do conhecimento por seis meses.