Topical Versus Intravenous Tranexamic Acid in Patients Undergoing Cardiac Surgery: The DEPOSITION Randomized Controlled Trial.

BACKGROUND: Although intravenous tranexamic acid is used in cardiac surgery to reduce bleeding and transfusion, topical tranexamic acid results in lower plasma concentrations compared with intravenous tranexamic acid, which may lower the risk of seizures. We aimed to determine whether topical tranexamic acid reduces the risk of in-hospital seizure without increasing the risk of transfusion among cardiac surgery patients. METHODS: We conducted a multicenter, double dummy, blinded, randomized controlled trial of patients recruited by convenience sampling in academic hospitals undergoing cardiac surgery with cardiopulmonary bypass. Between September 17, 2019, and November 28, 2023, a total of 3242 patients from 16 hospitals in 6 countries were randomly assigned (1:1 ratio) to receive either intravenous tranexamic acid (control) through surgery or topical tranexamic acid (treatment) at the end of surgery. The primary outcome was seizure, and the secondary outcome was red blood cell transfusion. After the last planned interim analysis, when 75% of anticipated participants had completed follow up, the data and safety monitoring board recommended to terminate the trial, and upon unblinding, the operations committee stopped the trial for safety. RESULTS: Among 3242 randomized patients (mean age, 66.0 years; 77.7% male), in-hospital seizure occurred in 4 of 1624 patients (0.2%) in the topical group, and 11 of 1628 patients (0.7%) in the intravenous group (absolute risk difference, -0.5% [95% CI, -0.9 to 0.03]; P=0.07). Red blood cell transfusion occurred in 570 patients (35.1%) in the topical group and in 433 (26.8%) in the intravenous group (absolute risk difference, 8.3% [95% CI, 5.2-11.5]; P=0.007). The absolute risk difference in transfusion of ≥4 units of red blood cells in the topical group compared with the intravenous group was 8.2% (95% CI, 3.4-12.9). CONCLUSIONS: Among patients undergoing cardiac surgery, topical administration of tranexamic acid resulted in an 8.3% absolute increase in transfusion without reducing the incidence of seizure, compared with intravenous tranexamic acid. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03954314.

Tranexamic Acid in Patients Undergoing Noncardiac Surgery.

BACKGROUND: Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS: We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS: A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.67 to 0.87; absolute difference, -2.6 percentage points; 95% CI, -3.8 to -1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 percentage points; 95% CI, -1.1 to 1.7; one-sided P = 0.04 for noninferiority). CONCLUSIONS: Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established. (Funded by the Canadian Institutes of Health Research and others; POISE-3 ClinicalTrials.gov number, NCT03505723.).

High-Sensitivity Troponin I after Cardiac Surgery and 30-Day Mortality.

BACKGROUND: Consensus recommendations regarding the threshold levels of cardiac troponin elevations for the definition of perioperative myocardial infarction and clinically important periprocedural myocardial injury in patients undergoing cardiac surgery range widely (from >10 times to ≥70 times the upper reference limit for the assay). Limited evidence is available to support these recommendations. METHODS: We undertook an international prospective cohort study involving patients 18 years of age or older who underwent cardiac surgery. High-sensitivity cardiac troponin I measurements (upper reference limit, 26 ng per liter) were obtained 3 to 12 hours after surgery and on days 1, 2, and 3 after surgery. We performed Cox analyses using a regression spline that explored the relationship between peak troponin measurements and 30-day mortality, adjusting for scores on the European System for Cardiac Operative Risk Evaluation II (which estimates the risk of death after cardiac surgery on the basis of 18 variables, including age and sex). RESULTS: Of 13,862 patients included in the study, 296 (2.1%) died within 30 days after surgery. Among patients who underwent isolated coronary-artery bypass grafting or aortic-valve replacement or repair, the threshold troponin level, measured within 1 day after surgery, that was associated with an adjusted hazard ratio of more than 1.00 for death within 30 days was 5670 ng per liter (95% confidence interval [CI], 1045 to 8260), a level 218 times the upper reference limit. Among patients who underwent other cardiac surgery, the corresponding threshold troponin level was 12,981 ng per liter (95% CI, 2673 to 16,591), a level 499 times the upper reference limit. CONCLUSIONS: The levels of high-sensitivity troponin I after cardiac surgery that were associated with an increased risk of death within 30 days were substantially higher than levels currently recommended to define clinically important periprocedural myocardial injury. (Funded by the Canadian Institutes of Health Research and others; VISION Cardiac Surgery ClinicalTrials.gov number, NCT01842568.).

Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery : An International Randomized Controlled Trial.

BACKGROUND: Among patients having noncardiac surgery, perioperative hemodynamic abnormalities are associated with vascular complications. Uncertainty remains about what intraoperative blood pressure to target and how to manage long-term antihypertensive medications perioperatively. OBJECTIVE: To compare the effects of a hypotension-avoidance and a hypertension-avoidance strategy on major vascular complications after noncardiac surgery. DESIGN: Partial factorial randomized trial of 2 perioperative blood pressure management strategies (reported here) and tranexamic acid versus placebo. (ClinicalTrials.gov: NCT03505723). SETTING: 110 hospitals in 22 countries. PATIENTS: 7490 patients having noncardiac surgery who were at risk for vascular complications and were receiving 1 or more long-term antihypertensive medications. INTERVENTION: In the hypotension-avoidance strategy group, the intraoperative mean arterial pressure target was 80 mm Hg or greater; before and for 2 days after surgery, renin-angiotensin-aldosterone system inhibitors were withheld and the other long-term antihypertensive medications were administered only for systolic blood pressures 130 mm Hg or greater, following an algorithm. In the hypertension-avoidance strategy group, the intraoperative mean arterial pressure target was 60 mm Hg or greater; all antihypertensive medications were continued before and after surgery. MEASUREMENTS: The primary outcome was a composite of vascular death and nonfatal myocardial injury after noncardiac surgery, stroke, and cardiac arrest at 30 days. Outcome adjudicators were masked to treatment assignment. RESULTS: The primary outcome occurred in 520 of 3742 patients (13.9%) in the hypotension-avoidance group and in 524 of 3748 patients (14.0%) in the hypertension-avoidance group (hazard ratio, 0.99 [95% CI, 0.88 to 1.12]; P = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term. LIMITATION: Adherence to the assigned strategies was suboptimal; however, results were consistent across different adherence levels. CONCLUSION: In patients having noncardiac surgery, our hypotension-avoidance and hypertension-avoidance strategies resulted in a similar incidence of major vascular complications. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong.

Preparing for patient partnership: A scoping review of patient partner engagement and evaluation in research.

BACKGROUND: Realizing patient partnership in research requires a shift from patient participation in ancillary roles to engagement as contributing members of research teams. While engaging patient partners is often discussed, impact is rarely measured. OBJECTIVE: Our primary aim was to conduct a scoping review of the impact of patient partnership on research outcomes. The secondary aim was to describe barriers and facilitators to realizing effective partnerships. SEARCH STRATEGY: A comprehensive bibliographic search was undertaken in EBSCO CINAHL, and Embase, MEDLINE and PsycINFO via Ovid. Reference lists of included articles were hand-searched. INCLUSION CRITERIA: Included studies were: (a) related to health care; (b) involved patients or proxies in the research process; and (c) reported results related to impact/evaluation of patient partnership on research outcomes. DATA EXTRACTION AND SYNTHESIS: Data were extracted from 14 studies meeting inclusion criteria using a narrative synthesis approach. MAIN RESULTS: Patient partners were involved in a range of research activities. Results highlight critical barriers and facilitators for researchers seeking to undertake patient partnerships to be aware of, such as power imbalances between patient partners and researchers, as well as valuing of patient partner roles. DISCUSSION: Addressing power dynamics in patient partner-researcher relationships and mitigating risks to patient partners through inclusive recruitment and training strategies may contribute towards effective engagement. Further guidance is needed to address evaluation strategies for patient partnerships across the continuum of patient partner involvement in research. CONCLUSIONS: Research teams can employ preparation strategies outlined in this review to support patient partnerships in their work.

Self-Management of Cardiac Pain in Women: A Meta-Summary of the Qualitative Literature.

Symptom recognition and self-management is instrumental in reducing the number of deaths related to coronary artery disease (CAD) in women. The purpose of this study was to synthesize qualitative research evidence on the self-management of cardiac pain and associated symptoms in women. Seven databases were systematically searched, and the concepts of the Individual and Family Self-Management Theory were used as the framework for data extraction and analysis. Search strategies yielded 22,402 citations, from which 35 qualitative studies were included in a final meta-summary, comprising data from 769 participants, including 437 (57%) women. The available literature focused cardiac pain self-management from a binary sex and gender perspective. Ethnicity was indicated in 19 (54%) studies. Results support individualized intervention strategies that promote goal setting and action planning, management of physical and emotional responses, and social facilitation provided through social support.

Risk Factors for Hospital Readmission Following Noncardiac Surgery: International Cohort Study.

Objective: To determine timing and risk factors associated with readmission within 30 days of discharge following noncardiac surgery. Background: Hospital readmission after noncardiac surgery is costly. Data on the drivers of readmission have largely been derived from single-center studies focused on a single surgical procedure with uncertainty regarding generalizability. Methods: We undertook an international (28 centers, 14 countries) prospective cohort study of a representative sample of adults ≥45 years of age who underwent noncardiac surgery. Risk factors for readmission were assessed using Cox regression (ClinicalTrials.gov, NCT00512109). Results: Of 36,657 eligible participants, 2744 (7.5%; 95% confidence interval [CI], 7.2-7.8) were readmitted within 30 days of discharge. Rates of readmission were highest in the first 7 days after discharge and declined over the follow-up period. Multivariable analyses demonstrated that 9 baseline characteristics (eg, cancer treatment in past 6 months; adjusted hazard ratio [HR], 1.44; 95% CI, 1.30-1.59), 5 baseline laboratory and physical measures (eg, estimated glomerular filtration rate or on dialysis; HR, 1.47; 95% CI, 1.24-1.75), 7 surgery types (eg, general surgery; HR, 1.86; 95% CI, 1.61-2.16), 5 index hospitalization events (eg, stroke; HR, 2.21; 95% CI, 1.24-3.94), and 3 other factors (eg, discharge to nursing home; HR, 1.61; 95% CI, 1.33-1.95) were associated with readmission. Conclusions: Readmission following noncardiac surgery is common (1 in 13 patients). We identified perioperative risk factors associated with 30-day readmission that can help frontline clinicians identify which patients are at the highest risk of readmission and target them for preventive measures.

A Novel Hospital-to-Home System for Children With Medical Complexities: Usability Testing Study.

BACKGROUND: Children with medical complexity (CMC) are a group of young people who have severe complex chronic conditions, substantial family-identified service needs, functional limitations, and high health care resource use. Technology-enabled hospital-to-home interventions designed to deliver comprehensive care in the home setting are needed to ease CMC family stress, provide proactive and comprehensive care to this fragile population, and avoid hospital admissions, where possible. OBJECTIVE: In this usability testing study, we aimed to assess areas of strength and opportunity within the DigiComp Kids system, a hospital-to-home intervention for CMC and their families and care providers. METHODS: Hospital-based clinicians, family members of medically complex children, and home-based clinicians participated in DigiComp Kids usability testing. Participants were recorded and tasked to think aloud while completing usability testing tasks. Participants were scored on the metrics of effectiveness, efficiency, and satisfaction, and the total usability score was calculated using the Single Usability Metric. Participants also provided insights into user experiences during the postusability testing interviews. RESULTS: A total of 15 participants (5 hospital-based clinicians, 6 family members, and 4 home-based clinicians) participated in DigiComp Kids usability testing. The participants were able to complete all assigned tasks independently. Error-free rates for tasks ranged from 58% to 100%; the average satisfaction rating across groups was ≥80%, as measured by the Single Ease Question. Task times of participants were variable compared with the task times of an expert DigiComp Kids user. Single Usability Metric scores ranged from 80.5% to 89.5%. In qualitative interviews, participants stressed the need to find the right fit between user needs and the effort required to use the system. Interviews also revealed that the value of the DigiComp Kids system was in its ability to create a digital bridge between hospital and home, enabling participants to foster and maintain connections across boundaries. CONCLUSIONS: Usability testing revealed strong scores across the groups. Insights gained include the importance of tailoring the implementation of the system to match individual user needs, streamlining key system features, and consideration of the meaning attached to system use by participants to allow for insight into system adoption and sustainment.

"Her Heart Matters"-Making Visible the Cardiac Pain Experiences of Women with Physical Disabilities and Heart Disease: A Qualitative Study.

BACKGROUND: Women with physical disabilities are faced with challenges in many aspects of life-education, work, income, relationships, as well as their general health. These women are at a greater risk of developing heart disease. This study aimed to explore the cardiac pain experiences of women with physical disabilities and heart disease within a Canadian healthcare context. METHODS: In this qualitative study, 8 women with physical disabilities and heart disease from across Canada were interviewed. They were asked about their pre-, peri-, and post-diagnostic experiences in the Canadian healthcare system. Transcripts of the interviews were analyzed using a hermeneutic phenomenological approach inspired by Ricoeur. RESULTS: Two main themes were uncovered in the analysis of the transcripts, as follows: (i) the diagnostic journey; and (ii) life with cardiac symptoms and a disability. The women indicated that they had experienced difficulties in utilizing the Canadian healthcare system prior to receiving a cardiac diagnosis, including long waitlists, expensive and unreliable transport, issues with accessibility, and dealing with providers' attitudinal barriers regarding disability. Receiving a diagnosis was challenging due to poor relationships with healthcare providers; however, having a same-sex provider seemed essential to receiving adequate care. Self-managing a disability and heart disease had significant physical and psychological impact, which was lightened by financial and social supports, modified lifestyle choices, and self-advocacy. CONCLUSIONS: Women with physical disabilities are often forgotten in discussions encompassing equity and inclusion. The participants' experiences offer insight into what changes are needed within the Canadian healthcare system in order to improve outcomes for these women.

CONTEXTE: Les femmes qui présentent une incapacité physique doivent composer avec des défis dans de nombreux aspects de leur vie, notamment en ce qui touche l'éducation, le travail, le revenu, les relations et la santé en général. Le risque de cardiopathie est plus important dans leur cas. Cette étude visait à examiner comment la douleur cardiaque est vécue par les femmes présentant une incapacité physique et une cardiopathie dans le contexte des soins de santé au Canada. MÉTHODOLOGIE: Dans le cadre de cette étude qualitative, huit femmes présentant une incapacité physique et une cardiopathie ont participé à des entrevues menées à l'échelle du Canada. Elles ont été interrogées sur leurs expériences au sein du système de santé canadien au cours des périodes précédant, entourant et suivant le diagnostic. Les transcriptions des entrevues ont été analysées en fonction d'une approche phénoménologique herméneutique inspirée par Ricœur. RÉSULTATS: Deux grands thèmes ressortent de l'analyse des transcriptions, à savoir : (i) le parcours diagnostique; (ii) la vie avec des symptômes cardiaques et une incapacité physique. Les femmes interrogées ont indiqué qu'elles avaient éprouvé des difficultés dans leur parcours au sein du système de santé canadien avant de recevoir un diagnostic en cardiologie, évoquant à cet égard les longues listes d'attente, les services de transport coûteux et peu fiables, les problèmes d'accessibilité et les obstacles liés à l'attitude des fournisseurs de soins vis-à-vis de l'incapacité physique. Le fait de recevoir un diagnostic a été éprouvant en raison de rapports difficiles avec les fournisseurs de soins de santé; cependant, le fait d'avoir un fournisseur de soins de sexe féminin semblait être une condition essentielle à une prestation de soins adéquate. L'autoprise en charge d'une incapacité physique et d'une cardiopathie a eu des répercussions physiques et psychologiques importantes qui ont pu être allégées par le soutien financier et social, des modifications des habitudes de vie et l'autonomie sociale. CONCLUSIONS: Les femmes qui présentent une incapacité physique sont souvent laissées pour compte dans les discussions portant sur l'équité et l'inclusion. Le vécu des participantes donne un aperçu des changements qui doivent être apportés au sein du système de santé canadien afin d'améliorer les résultats chez ces femmes.

Continuous Noninvasive Remote Automated Blood Pressure Monitoring With Novel Wearable Technology: A Preliminary Validation Study.

BACKGROUND: Wearable continuous monitoring biosensor technologies have the potential to transform postoperative care with early detection of impending clinical deterioration. OBJECTIVE: Our aim was to validate the accuracy of Cloud DX Vitaliti continuous vital signs monitor (CVSM) continuous noninvasive blood pressure (cNIBP) measurements in postsurgical patients. A secondary aim was to examine user acceptance of the Vitaliti CVSM with respect to comfort, ease of application, sustainability of positioning, and aesthetics. METHODS: Included participants were ≥18 years old and recovering from surgery in a cardiac intensive care unit (ICU). We targeted a maximum recruitment of 80 participants for verification and acceptance testing. We also oversampled to minimize the effect of unforeseen interruptions and other challenges to the study. Validation procedures were according to the International Standards Organization (ISO) 81060-2:2018 standards for wearable, cuffless blood pressure (BP) measuring devices. Baseline BP was determined from the gold-standard ICU arterial catheter. The Vitaliti CVSM was calibrated against the reference arterial catheter. In static (seated in bed) and supine positions, 3 cNIBP measurements, each 30 seconds, were taken for each patient with the Vitaliti CVSM and an invasive arterial catheter. At the conclusion of each test session, captured cNIBP measurements were extracted using MediCollector BEDSIDE data extraction software, and Vitaliti CVSM measurements were extracted to a secure laptop through a cable connection. The errors of these determinations were calculated. Participants were interviewed about device acceptability. RESULTS: The validation analysis included data for 20 patients. The average times from calibration to first measurement in the static position and to first measurement in the supine position were 133.85 seconds (2 minutes 14 seconds) and 535.15 seconds (8 minutes 55 seconds), respectively. The overall mean errors of determination for the static position were -0.621 (SD 4.640) mm Hg for systolic blood pressure (SBP) and 0.457 (SD 1.675) mm Hg for diastolic blood pressure (DBP). Errors of determination were slightly higher for the supine position, at 2.722 (SD 5.207) mm Hg for SBP and 2.650 (SD 3.221) mm Hg for DBP. The majority rated the Vitaliti CVSM as comfortable. This study was limited to evaluation of the device during a very short validation period after calibration (ie, that commenced within 2 minutes after calibration and lasted for a short duration of time). CONCLUSIONS: We found that the Cloud DX's Vitaliti CVSM demonstrated cNIBP measurement in compliance with ISO 81060-2:2018 standards in the context of evaluation that commenced within 2 minutes of device calibration; this device was also well-received by patients in a postsurgical ICU setting. Future studies will examine the accuracy of the Vitaliti CVSM in ambulatory contexts, with attention to assessment over a longer duration and the impact of excessive patient motion on data artifacts and signal quality. TRIAL REGISTRATION: ClinicalTrials.gov NCT03493867; https://clinicaltrials.gov/ct2/show/NCT03493867.

Beyond Wellness Monitoring: Continuous Multiparameter Remote Automated Monitoring of Patients.

The pursuit of more efficient patient-friendly health systems and reductions in tertiary health services use has seen enormous growth in the application and study of remote patient monitoring systems for cardiovascular patient care. While there are many consumer-grade products available to monitor patient wellness, the regulation of these technologies varies considerably, with most products having little to no evaluation data. As the science and practice of virtual care continues to evolve, clinicians and researchers can benefit from an understanding of more comprehensive solutions capable of monitoring multiple biophysical parameters (eg, oxygen saturation, heart rate) continuously and simultaneously. These devices, herein referred to as continuous multiparameter remote automated monitoring (CM-RAM) devices, have the potential to revolutionise virtual patient care. Through seamless integration of multiple biophysical signals, CM-RAM technologies can allow for the acquisition of high-volume big data for the development of algorithms to facilitate early detection of negative changes in patient health status and timely clinician response. In this article, we review key principles, architecture, and components of CM-RAM technologies. Work to date in this field and related implications are also presented, including strategic priorities for advancing the science and practice of CM-RAM.

Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM): protocol for a randomized controlled trial.

BACKGROUND: After nonelective (i.e., semiurgent, urgent and emergent) surgeries, patients discharged from hospitals are at risk of readmissions, emergency department visits or death. During the coronavirus disease 2019 (COVID-19) pandemic, we are undertaking the Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM) trial to determine if virtual care with remote automated monitoring (RAM) compared with standard care will increase the number of days adult patients remain alive at home after being discharged following nonelective surgery. METHODS: We are conducting a randomized controlled trial in which 900 adults who are being discharged after nonelective surgery from 8 Canadian hospitals are randomly assigned to receive virtual care with RAM or standard care. Outcome adjudicators are masked to group allocations. Patients in the experimental group learn how to use the study's tablet computer and RAM technology, which will measure their vital signs. For 30 days, patients take daily biophysical measurements and complete a recovery survey. Patients interact with nurses via the cellular modem-enabled tablet, who escalate care to preassigned and available physicians if RAM measurements exceed predetermined thresholds, patients report symptoms, a medication error is identified or the nurses have concerns they cannot resolve. The primary outcome is number of days alive at home during the 30 days after randomization. INTERPRETATION: This trial will inform management of patients after discharge following surgery in the COVID-19 pandemic and offer insights for management of patients who undergo nonelective surgery in a nonpandemic setting. Knowledge dissemination will be supported through an online multimedia resource centre, policy briefs, presentations, peer-reviewed journal publications and media engagement. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT04344665.

Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial.

OBJECTIVE: To determine if virtual care with remote automated monitoring (RAM) technology versus standard care increases days alive at home among adults discharged after non-elective surgery during the covid-19 pandemic. DESIGN: Multicentre randomised controlled trial. SETTING: 8 acute care hospitals in Canada. PARTICIPANTS: 905 adults (≥40 years) who resided in areas with mobile phone coverage and were to be discharged from hospital after non-elective surgery were randomised either to virtual care and RAM (n=451) or to standard care (n=454). 903 participants (99.8%) completed the 31 day follow-up. INTERVENTION: Participants in the experimental group received a tablet computer and RAM technology that measured blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, and body weight. For 30 days the participants took daily biophysical measurements and photographs of their wound and interacted with nurses virtually. Participants in the standard care group received post-hospital discharge management according to the centre's usual care. Patients, healthcare providers, and data collectors were aware of patients' group allocations. Outcome adjudicators were blinded to group allocation. MAIN OUTCOME MEASURES: The primary outcome was days alive at home during 31 days of follow-up. The 12 secondary outcomes included acute hospital care, detection and correction of drug errors, and pain at 7, 15, and 30 days after randomisation. RESULTS: All 905 participants (mean age 63.1 years) were analysed in the groups to which they were randomised. Days alive at home during 31 days of follow-up were 29.7 in the virtual care group and 29.5 in the standard care group: relative risk 1.01 (95% confidence interval 0.99 to 1.02); absolute difference 0.2% (95% confidence interval -0.5% to 0.9%). 99 participants (22.0%) in the virtual care group and 124 (27.3%) in the standard care group required acute hospital care: relative risk 0.80 (0.64 to 1.01); absolute difference 5.3% (-0.3% to 10.9%). More participants in the virtual care group than standard care group had a drug error detected (134 (29.7%) v 25 (5.5%); absolute difference 24.2%, 19.5% to 28.9%) and a drug error corrected (absolute difference 24.4%, 19.9% to 28.9%). Fewer participants in the virtual care group than standard care group reported pain at 7, 15, and 30 days after randomisation: absolute differences 13.9% (7.4% to 20.4%), 11.9% (5.1% to 18.7%), and 9.6% (2.9% to 16.3%), respectively. Beneficial effects proved substantially larger in centres with a higher rate of care escalation. CONCLUSION: Virtual care with RAM shows promise in improving outcomes important to patients and to optimal health system function. TRIAL REGISTRATION: ClinicalTrials.gov NCT04344665.

Health-Related Quality of Life in Patients With Atrial Fibrillation Treated With Catheter Ablation or Antiarrhythmic Drug Therapy: A Systematic Review and Meta-analysis.

BACKGROUND: Catheter ablation (CA) is performed in patients with atrial fibrillation (AF) to reduce symptoms and improve health-related quality of life (HRQL). METHODS: This systematic review and meta-analysis of randomized controlled trials (RCTs) evaluated CA of any energy modality compared with antiarrhythmic drugs (AADs) using inverse-variance random-effects models. We searched for RCTs reporting HRQL and AF-related symptoms at 3, 6, 12, 24, 48, and 60 months after treatment as well as the number of repeat ablations. RESULTS: Of 15,878 records, we included 13 RCTs of CA vs AADs for the analyses of HRQL, 7 RCTs for the analyses of AF-related symptoms, and 13 RCTs for the number of repeat ablations. For the HRQL analyses at 3 months, there were significant increases in both the Physical Component Summary score (3 months' standardized mean difference = 0.58 [0.39-0.78]; P < 0.00001, I 2 = 6%, 3 trials, n = 443) and the Mental Component Summary score (3 months' standardized mean difference = 0.57 [0.37-0.77]; P < 0.00001, I 2 = 0%, 3 trials, n = 443), favouring CA over AADs. These differences were sustained at 12 months but not >24 months after randomization. Similar results were seen for AF-related symptoms. The number of repeat ablations and success rates after procedure varied considerably across trials. CONCLUSIONS: Evidence from few trials suggests that CA improves physical and mental health and AF-related symptoms in the short term, but these benefits decrease with time. More trials, reporting both HRQL and AF-related symptoms, at consistent time points are needed to assess the effectiveness of CA for the treatment of AF.

CONTEXTE: L'ablation par cathéter (AC) est réalisée chez les patients atteints de fibrillation auriculaire (FA) afin d'atténuer les symptômes et d'améliorer la qualité de vie liée à la santé (QVLS). MÉTHODOLOGIE: Cette revue systématique et méta-analyse d'essais contrôlés à répartition aléatoire (ECRA) a permis d'évaluer l'AC, toutes modalités énergétiques confondues, comparativement aux agents antiarythmiques (AA) à l'aide de modèles à effets aléatoires à variance inverse. Nous avons recherché les ECRA qui faisaient état de la QVLS et des symptômes liés à la FA à 3, 6, 12, 24, 48 et 60 mois après le traitement et qui précisaient le nombre d'ablations répétées. RÉSULTATS: À partir de 15 878 entrées, nous avons retenu 13 ECRA comparant l'AC à des AA pour l'analyse de la QVLS, 7 autres pour l'analyse des symptômes liés à la FA et 13 de plus aux fins de calcul du nombre d'ablations répétées. L'analyse de la QVLS à 3 mois indique une augmentation significative du score sommaire de la composante physique (différence moyenne normalisée à 3 mois = 0,58 [0,39-0,78]; p < 0,00001, I 2 = 6 %, 3 essais, n = 443) et du score sommaire de la composante mentale (différence moyenne normalisée à 3 mois = 0,57 [0,37-0,77]; p < 0,00001, I 2 = 0 %, 3 essais, n = 443), faisant pencher la balance en faveur de l'AC plutôt que des AA. Ces différences persistaient à 12 mois après la répartition aléatoire, mais pas aux moments d'évaluation ultérieurs (24, 48 et 60 mois). Des résultats similaires ont été observés au chapitre des symptômes liés à la FA. Le nombre d'ablations répétées et le taux de réussite postopératoire variaient considérablement d'un essai à l'autre. CONCLUSIONS: Les données probantes de quelques essais donnent à penser que l'AC améliore la santé physique et mentale ainsi que les symptômes liés à la FA à court terme, mais que ces bienfaits s'atténuent avec le temps. D'autres essais faisant état de la QVLS et des symptômes liés à la FA, à des moments d'évaluation constants, devront être réalisés pour évaluer l'efficacité réelle de l'AC dans le traitement de la FA.

Use of Synchronous Digital Health Technologies for the Care of Children With Special Health Care Needs and Their Families: Scoping Review.

BACKGROUND: Use of synchronous digital health technologies for care delivery to children with special health care needs (having a chronic physical, behavioral, developmental, or emotional condition in combination with high resource use) and their families at home has shown promise for improving outcomes and increasing access to care for this medically fragile and resource-intensive population. However, a comprehensive description of the various models of synchronous home digital health interventions does not exist, nor has the impact of such interventions been summarized to date. OBJECTIVE: We aim to describe the various models of synchronous home digital health that have been used in pediatric populations with special health care needs, their outcomes, and implementation barriers. METHODS: A systematic scoping review of the literature was conducted, guided by the Arksey and O'Malley Scoping Review Framework. MEDLINE, CINAHL, and EMBASE databases were searched from inception to June 2018, and the reference lists of the included systematic reviews and high-impact journals were hand-searched. RESULTS: A total of 38 articles were included in this review. Interventional articles are described as feasibility studies, studies that aim to provide direct care to children with special health care needs, and studies that aim to support family members to deliver care to children with special health care needs. End-user involvement in the design and implementation of studies is evaluated using a human-centered design framework, and factors affecting the implementation of digital health programs are discussed in relation to technological, human, and systems factors. CONCLUSIONS: The use of digital health to care for children with special health care needs presents an opportunity to leverage the capacity of technology to connect patients and their families to much-needed care from expert health care providers while avoiding the expenses and potential harms of the hospital-based care system. Strategies to scale and spread pilot studies, such as involving end users in the co-design techniques, are needed to optimize digital health programs for children with special health care needs.

Examination of psychological risk factors for chronic pain following cardiac surgery: protocol for a prospective observational study.

INTRODUCTION: Approximately 400 000 Americans and 36 000 Canadians undergo cardiac surgery annually, and up to 56% will develop chronic postsurgical pain (CPSP). The primary aim of this study is to explore the association of pain-related beliefs and gender-based pain expectations on the development of CPSP. Secondary goals are to: (A) explore risk factors for poor functional status and patient-level cost of illness from a societal perspective up to 12 months following cardiac surgery; and (B) determine the impact of CPSP on quality-adjusted life years (QALYs) borne by cardiac surgery, in addition to the incremental cost for one additional QALY gained, among those who develop CPSP compared with those who do not. METHODS AND ANALYSES: In this prospective cohort study, 1250 adults undergoing cardiac surgery, including coronary artery bypass grafting and open-heart procedures, will be recruited over a 3-year period. Putative risk factors for CPSP will be captured prior to surgery, at postoperative day 3 (in hospital) and day 30 (at home). Outcome data will be collected via telephone interview at 6-month and 12-month follow-up. We will employ generalised estimating equations to model the primary (CPSP) and secondary outcomes (function and cost) while adjusting for prespecified model covariates. QALYs will be estimated by converting data from the Short Form-12 (version 2) to a utility score. ETHICS AND DISSEMINATION: This protocol has been approved by the responsible bodies at each of the hospital sites, and study enrolment began May 2015. We will disseminate our results through CardiacPain.Net, a web-based knowledge dissemination platform, presentation at international conferences and publications in scientific journals. TRIAL REGISTRATION NUMBER: NCT01842568.

Self-Management Interventions for Women With Cardiac Pain: A Systematic Review and Meta-analysis.

BACKGROUND: Cardiac pain is considered the primary indicator of coronary artery disease (CAD). Existing reviews lack appropriate numbers of women or sex-based subgroup analyses, or both; thus, the benefits of self-management (women with cardiac pain actively participating in their own care and treatment) remain uncertain. METHODS: Using methods described by the Evidence for Policy and Practice Information and Co-ordinating Centre at the Institute of Education, 7 databases were systematically searched to examine and synthesize the evidence on self-management interventions for women with cardiac pain and cardiac pain equivalents, such as fatigue, dyspnea, and exhaustion. RESULTS: Our search yielded 22,402 article titles and abstracts. Of these, 57 randomized controlled trials were included in a final narrative synthesis, comprising data from 13,047 participants, including 5299 (41%) women. Self-management interventions targeting cardiac pain in women compared with a control population reduced (1) cardiac pain frequency and cardiac pain proportion (obstructive and nonobstructive CAD), (2) fatigue at 12 months, and (3) dyspnea at 2 months. There was no evidence of group differences in postprocedural (percutaneous coronary intervention or cardiac surgery) pain. Results indicated that self-management interventions for cardiac pain were more effective if they included a greater proportion of women (standardized mean difference [SMD], -0.01; standard error, 0.003; P = 0.02), goal setting (SMD, -0.26; 95% confidence interval [CI], -0.49 to -0.03), and collaboration/support from health care providers (SMD, -0.57; 95% CI, -1.00 to -0.14). CONCLUSIONS: The results of this review suggest that self-management interventions reduce cardiac pain and cardiac pain equivalents.