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Background. In the early 1980s there emerged in nursing a self-conscious and well-articulated concern to articulate nursing's contribution to patient care. This has fostered the production of a large volume of practice narratives that today form the basis of professional self-understanding. First-person practice narratives are now widely used as the evidence base for nursing expertise, not only in their natural home, the world of interpretative research, but also in the bureaucratic-judicial domain of professional regulation, health care organizations, trades unions and professional associations. Aim. The aim of this paper is to question the use of individual narrative accounts of nursing practice as evidence of nursing expertise. Method. We examine the model, method, and continuing consequences of these discursive formations of practice. First, we present a methodological discussion of how personal narratives are produced by the interplay between discourse and subjectivity. Second, we explore clinical narratives of expertise in the work of Patricia Benner and others to uncover the common template for contemporary narrative. Discussion. Narrative production in nursing has led to particular constructions, rather than free representations of practice. It is these particular constructions that we call into question. Rather than viewing these narratives as revelatory of nursing practice, we argue that they place a 'spotlight' on the individual actor - the nurse - with an absence of structural practice context. Conclusion. We make the case that treatment of these narratives as individual evidence of expertise fundamentally misunderstands their function and purpose, and reduces the constitution of nursing expertise to the performance of a palatable and highly desirable discourse for a nursing audience. [ABSTRACT FROM AUTHOR]

AIM AND BACKGROUND: Same-day surgeries are becoming routine for many surgical procedures. However, the degree to which patients need help with pain management at home following laparoscopic cholecystectomy (LC), shoulder, or hand ambulatory day surgery has received minimal examination. This study examined pain and related interference, analgesic use and adverse events, complications and resources utilized, and adequacy of postdischarge information at four time periods. METHODS: Data were collected from 180 patients by telephone interviews at 24, 48 and 72 hours, and 7 days after discharge. Patients (n = 78 hand, 48 shoulder, 54 LC surgery) were on average 41 years old. RESULTS: For all patients, worst 24-hour pain was reported as moderate to severe at all time periods. Using repeated measures anova demonstrated that shoulder patients had significantly more pain and overall pain-related interference, particularly in sleep and work, from 24 hours to day 7 than did hand or LC patients. The main analgesic taken was acetaminophen (paracetamol) with codeine 30 mg; 50% took no analgesia from 72 hours. About 20% experienced analgesic adverse events within 72 hours, mainly constipation and nausea. Only

Background: Cardiac pain arising from an acute coronary syndrome (ACS) has been described as a complex phenomenon. Lacking are cardiac pain assessments that describe acute ACS pain using a multi-factoral pain assessment tool during the first eight hours of an emergent ACS-related pain episode. Aim: To examine the sensory-discriminative, motivational-affective and cognitive-evaluative dimensions of an emergent ACS-related pain episode. Methods: A descriptive, correlational, cross-sectional design was used to collect data on cardiac pain intensity scores (numeric rating scale-NRS; McGill Pain Questionnaire MPQ-SF) and state anxiety (Speilberger State-Anxiety Inventory-SAI) on 121 ACS patients. Results: The mean age was 67.6 ± 13,50% were female, 40% had Non-ST-Elevation myocardial infarction and 60% had unstable angina. Patients' cardiac pain intensity scores (NRS) remained in the mild range from 1.1 ± 2.2 to 2.4 ±2.7. MPQ-66% of the sample described their global pain as distressing (moderate pain), and 26% reported ACS pain as excruciating (severe pain). ACS pain was described as a mixture of acute injury (nociceptive) and nerve damage (neuropathic) pain. State anxiety was persistent at a high level and ranged from 44.0 ± 7.2 to 46.2 ± 6.6. Conclusions: ACS patients reported both nociceptive and neuropathic types of cardiac pain. It is unclear if individual pain perceptions are due to: i) the pathophysiology of clot formation, ii) co-morbidities, iii) occurrence of a first or repeat ACS episode, or iv) the equivocal relationship of angina pain and myocardial ischemia. Significance: Management of ACS-related pain requires an understanding of the interplay of ischemic, metabolic and neuropathophysiological mechanisms that contribute to individuals' cardiac pain experiences. Use of a multi-dimensional pain assessment tool is necessary to screen those at risk for development of persistent cardiac pain. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Surgical site infections (SSIs) occur frequently and impact patients and health care systems. Remote surveillance of surgical wounds is currently limited by the need for manual assessment by clinicians. Machine learning (ML)-based methods have recently been used to address various aspects of the postoperative wound healing process and may be used to improve the scalability and cost-effectiveness of remote surgical wound assessment., Objective: The objective of this review was to provide an overview of the ML methods that have been used to identify surgical wound infections from images., Methods: We conducted a scoping review of ML approaches for visual detection of SSIs following the JBI (Joanna Briggs Institute) methodology. Reports of participants in any postoperative context focusing on identification of surgical wound infections were included. Studies that did not address SSI identification, surgical wounds, or did not use image or video data were excluded. We searched MEDLINE, Embase, CINAHL, CENTRAL, Web of Science Core Collection, IEEE Xplore, Compendex, and arXiv for relevant studies in November 2022. The records retrieved were double screened for eligibility. A data extraction tool was used to chart the relevant data, which was described narratively and presented using tables. Employment of TRIPOD (Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis) guidelines was evaluated and PROBAST (Prediction Model Risk of Bias Assessment Tool) was used to assess risk of bias (RoB)., Results: In total, 10 of the 715 unique records screened met the eligibility criteria. In these studies, the clinical contexts and surgical procedures were diverse. All papers developed diagnostic models, though none performed external validation. Both traditional ML and deep learning methods were used to identify SSIs from mostly color images, and the volume of images used ranged from under 50 to thousands. Further, 10 TRIPOD items were reported in at least 4 studies, though 15 items were reported in fewer than 4 studies. PROBAST assessment led to 9 studies being identified as having an overall high RoB, with 1 study having overall unclear RoB., Conclusions: Research on the image-based identification of surgical wound infections using ML remains novel, and there is a need for standardized reporting. Limitations related to variability in image capture, model building, and data sources should be addressed in the future., (©Juan Pablo Tabja Bortesi, Jonathan Ranisau, Shuang Di, Michael McGillion, Laura Rosella, Alistair Johnson, PJ Devereaux, Jeremy Petch. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 18.01.2024.)

Background: In previous analyses, myocardial injury after noncardiac surgery, major bleeding, and sepsis were independently associated with most deaths in the 30 days after noncardiac surgery, but most of these deaths occurred during the index hospitalization for surgery. The authors set out to describe outcomes after discharge from hospital up to 1 yr after inpatient noncardiac surgery and associations between predischarge complications and postdischarge death up to 1 yr after surgery., Methods: This study was an analysis of patients discharged after inpatient noncardiac surgery in a large international prospective cohort study across 28 centers from 2007 to 2013 of patients aged 45 yr or older followed to 1 yr after surgery. The study estimated (1) the cumulative postdischarge incidence of death and other outcomes up to a year after surgery and (2) the adjusted time-varying associations between postdischarge death and predischarge complications including myocardial injury after noncardiac surgery, major bleeding, sepsis, infection without sepsis, stroke, congestive heart failure, clinically important atrial fibrillation or flutter, amputation, venous thromboembolism, and acute kidney injury managed with dialysis., Results: Among 38,898 patients discharged after surgery, the cumulative 1-yr incidence was 5.8% (95% CI, 5.5 to 6.0%) for all-cause death and 24.7% (95% CI, 24.2 to 25.1%) for all-cause hospital readmission. Predischarge complications were associated with 33.7% (95% CI, 27.2 to 40.2%) of deaths up to 30 days after discharge and 15.0% (95% CI, 12.0 to 17.9%) up to 1 yr. Most of the association with death was due to myocardial injury after noncardiac surgery (15.6% [95% CI, 9.3 to 21.9%] of deaths within 30 days, 6.4% [95% CI, 4.1 to 8.7%] within 1 yr), major bleeding (15.0% [95% CI, 8.3 to 21.7%] within 30 days, 4.7% [95% CI, 2.2 to 7.2%] within 1 yr), and sepsis (5.4% [95% CI, 2.2 to 8.6%] within 30 days, 2.1% [95% CI, 1.0 to 3.1%] within 1 yr)., Conclusions: One in 18 patients 45 yr old or older discharged after inpatient noncardiac surgery died within 1 yr, and one quarter were readmitted to the hospital. The risk of death associated with predischarge perioperative complications persists for weeks to months after discharge., (Copyright © 2023 American Society of Anesthesiologists. All Rights Reserved.)

Purpose: Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery. Although the evidence suggests that beta blockers prevent POAF, they often cause hypotension. Landiolol, an ultra-short-acting β 1 blocker, may prevent POAF, without adverse hemodynamic consequences., Source: We searched MEDLINE, CENTRAL, Embase, and trial registries between January 1970 and March 2022. We included randomized controlled trials (RCTs) that evaluated the effect of landiolol for the prevention of POAF after cardiac surgery. Two reviewers independently assessed eligibility, extracted data, and assessed risk of bias using the Risk of Bias 2.0 tool. We pooled data using random-effects models. We used the Grading of Recommendations, Assessment, Development and Evaluations framework to assess certainty of evidence., Principal Findings: Nine RCTs including 868 participants met the eligibility criteria. Patients randomized to landiolol (56/460) had less POAF compared with controls (133/408) with a relative risk (RR) of 0.40 (95% confidence interval [CI], 0.30 to 0.54; I 2  = 0%;) and an absolute risk of 12.2% vs 32.6% (absolute risk difference, 20.4%; 95% CI, 15.0 to 25.0). Landiolol resulted in a shorter hospital length-of-stay (LOS) (268 patients; mean difference, -2.32 days; 95% CI, -4.02 to -0.57; I 2  = 0%). We found no significant difference in bradycardia (RR, 1.11; 95% CI, 0.48 to 2.56; I 2  = 0%). No hypotension was reported with landiolol. We judged the certainty of evidence as moderate for POAF (because of indirectness as outcomes were not clearly defined) and low for LOS (because of imprecision and concern of reporting bias)., Conclusion: In patients undergoing cardiac surgery, landiolol likely reduces POAF and may reduce LOS. A definitive large RCT is needed to confirm these findings., Study Registration: PROSPERO (CRD42021262703); registered 25 July 2021., (© 2023. The Author(s).)

Background: How often a child naps, during infancy, is believed to reflect both intrinsic factors, that is, the need of an immature brain to consolidate information soon after it is acquired, and environmental factors. Difficulty accounting for important environmental factors that interfere with a child's sleep needs (e.g., attending daycare) has clouded our ability to understand the role of intrinsic drivers of napping frequency., Methods: Here we investigate sleep patterns in association with two measures of cognitive ability, vocabulary size, measured with the Oxford-Communicative Development Inventory ( N  = 298) and cognitive executive functions (EF), measured with the Early EF Questionnaire ( N  = 463), in a cohort of 8-38-month-olds. Importantly, because of the social distancing measures imposed during the Covid-19 Spring 2020 lockdown, in the UK, measures of sleep were taken when children did not access daycare settings., Results: We find that children with more frequent but shorter naps than expected for their age had lower concurrent receptive vocabularies, lower cognitive EF and a slower increase in expressive vocabulary from spring to winter 2020, when age, sex, and SES were accounted for. The negative association between vocabulary and frequency of naps became stronger with age., Conclusions: These findings suggest that the structure of daytime sleep is an indicator of cognitive development and highlight the importance of considering environmental perturbations and age when investigating developmental correlates of sleep., Competing Interests: The authors have declared that they have no competing or potential conflicts of interest., (© 2023 The Authors. JCPP Advances published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.)

Objective: The objective of this review is to provide an overview of the existing literature on psychosocial interventions aimed at addressing suicidality among adults in the context of an inpatient psychiatric admission., Introduction: For individuals admitted to a psychiatric inpatient unit, their risk of suicide in the period following discharge is significantly higher compared with the prevalence of death by suicide in the general population. During an inpatient admission, there is opportunity for supportive interventions that may lead to reduced risks of suicide. Yet, interventions that directly address suicidality have primarily been studied in outpatient settings. A broader understanding of inpatient interventions will assist clinicians in understanding key considerations when implementing suicide-related interventions in this setting., Inclusion Criteria: Studies involving adult patients (≥18 years) that describe psychosocial interventions aiming to address suicidality in the context of inpatient psychiatry will be considered. Studies that only describe pharmacological interventions will be excluded, as will studies that describe psychosocial interventions initiated in the context of an outpatient setting., Methods: We will search MEDLINE (Ovid), CINAHL (EBSCO), APA PsycINFO (EBSCOhost), the Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and Web of Science for studies in English and Spanish. Gray literature and materials will also be searched for using Google and websites relevant to the review topic. No date limit will be set. Two independent reviewers will screen titles and abstracts from studies that meet the inclusion criteria and review eligible studies at full text. Data will be extracted and synthesized and then presented in tabular and graphical formats accompanied by a narrative summary., Details of the Review Available at: Open Science Framework https://osf.io/5cwhx., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 JBI.)

Background: Myocardial injury after non-cardiac surgery (MINS), based on measurement of troponin T, is associated with perioperative major adverse cardiovascular events (MACE). We therefore determined the high-sensitivity troponin I (hsTnI) thresholds associated with 30 day MACE after non-cardiac surgery., Methods: We performed a nested biobank cohort study of 4553 patients from the Vascular Events in Non-Cardiac Surgery Patients Cohort Evaluation (VISION) Study. We measured hsTnI (ADVIA Centaur® hsTnI assay) on postoperative days 1 to 3 in patients ≥45 years undergoing non-cardiac surgery. An iterative Cox proportional hazard model determined peak postoperative hsTnI thresholds independently associated with MACE (i.e., death, myocardial infarction occurring on postoperative day 4 or after, non-fatal cardiac arrest, or congestive heart failure) within 30 days after surgery., Results: MACE occurred in 89/4545 (2.0%) patients. Peak hsTnI values of <75 ng/L, 75 ng/L to <1000 ng/L, and ≥1000 ng/L were associated with 1.2% (95% CI, 0.9-1.6), 7.1% (95% CI, 4.8-10.5), and 25.9% (95% CI, 16.3-38.4) MACE, respectively. Compared to peak hsTnI <75 ng/L, values 75 ng/L to <1000 ng/L and ≥1000 ng/L were associated with adjusted hazard ratios (aHR) of 4.53 (95% CI, 2.75-7.48) and 16.17 (95% CI, 8.70-30.07), respectively. MACE was observed in 9% of patients with peak hsTnI ≥75 ng/L vs 1% in patients with peak hsTnI <75 ng/L (aHR 5.76; 95% CI, 3.64-9.11). A peak hsTnI ≥75 ng/L was associated with MACE in the presence (aHR 9.35; 95% CI, 5.28-16.55) or absence (aHR 3.99; 95% CI, 2.19-7.25) of ischemic features of myocardial injury., Conclusion: A peak postoperative hsTnI ≥75 ng/L was associated with >5-fold increase in the risk of 30 days MACE compared to levels <75 ng/L. This threshold could be used for MINS diagnosis when the ADVIA Centaur hsTnI assay is used.Clinicaltrials.gov Registration Number: NCT00512109., (© American Association for Clinical Chemistry 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background Diagnosis of shockable rhythms leading to defibrillation remains integral to improving out-of-hospital cardiac arrest outcomes. New machine learning techniques have emerged to diagnose arrhythmias on ECGs. In out-of-hospital cardiac arrest, an algorithm within an automated external defibrillator is the major determinant to deliver defibrillation. This study developed and validated the performance of a convolution neural network (CNN) to diagnose shockable arrhythmias within a novel, miniaturized automated external defibrillator. Methods and Results There were 26 464 single-lead ECGs that comprised the study data set. ECGs of 7-s duration were retrospectively adjudicated by 3 physician readers (N=18 total readers). After exclusions (N=1582), ECGs were divided into training (N=23 156), validation (N=721), and test data sets (N=1005). CNN performance to diagnose shockable and nonshockable rhythms was reported with area under the receiver operating characteristic curve analysis, F1, and sensitivity and specificity calculations. The duration for the CNN to output was reported with the algorithm running within the automated external defibrillator. Internal and external validation analyses included CNN performance among arrhythmias, often mistaken for shockable rhythms, and performance among ECGs modified with noise to mimic artifacts. The CNN algorithm achieved an area under the receiver operating characteristic curve of 0.995 (95% CI, 0.990-1.0), sensitivity of 98%, and specificity of 100% to diagnose shockable rhythms. The F1 scores were 0.990 and 0.995 for shockable and nonshockable rhythms, respectively. After input of a 7-s ECG, the CNN generated an output in 383±29 ms (total time of 7.383 s). The CNN outperformed adjudicators in classifying atrial arrhythmias as nonshockable (specificity of 99.3%-98.1%) and was robust against noise artifacts (area under the receiver operating characteristic curve range, 0.871-0.999). Conclusions We demonstrate high diagnostic performance of a CNN algorithm for shockable and nonshockable rhythm arrhythmia classifications within a digitally connected automated external defibrillator. Registration URL: https://clinicaltrials.gov/ct2/show/NCT03662802; Unique identifier: NCT03662802.

Previous studies have shown that caregivers' sensitive, responsive interactions with young children can boost language development. We explored the association between caregivers' sensitivity and the vocabulary development of their 8-to-36-month-olds during COVID-19 when family routines were unexpectedly disrupted. Measuring caregivers' sensitivity from home interaction videos at three timepoints, we found that children who experienced more-sensitive concurrent interactions had higher receptive and expressive vocabularies (N=100). Children whose caregivers showed more-sensitive interactions at the beginning of the pandemic showed greater expressive vocabulary growth six (but not 12) months later (n=58). Significant associations with receptive vocabulary growth were not observed. Our findings highlight the importance of sensitivity at a time when other positive influences on language development were compromised.

Variation in infants' home environment is implicated in their cognitive and psycho-social development. The pandemic has intensified variations in home environments through exacerbating socioeconomic inequalities, and increasing psychological stressors for some families. This study investigates the effects of parental (predominantly maternal) mental health, enriching activities and screen use on 280 24- to 52-month-olds' executive functions, internalising and externalising problems, and pro-social behaviour; with socioeconomic status and social support as contextual factors. Our results indicate that aspects of the home environment are differentially associated with children's cognitive and psycho-social development. Parents who experienced sustained mental distress during the pandemic tended to report higher child externalising and internalising problems, and executive function difficulties at follow-up. Children who spent more time engaged in enriching activities with their parents showed stronger executive functions and social competence six months later. Screen use levels during the first year of the pandemic were not associated with outcomes. To mitigate the risk of persistent negative effects for this 'pandemic generation' of infants, our study highlights the importance of supporting parents' mental health. As our results demonstrate the impact of social support on mental health, investing in support services and interventions promoting building support networks are likely to be beneficial., (© 2022 The Authors. Infancy published by Wiley Periodicals LLC on behalf of International Congress of Infant Studies.)

Objective: Factors that physicians and patients consider when making decisions about using or recommending health apps are not well understood. We explored these factors to better assess how to support such decision making., Methods: We conducted an exploratory cross-sectional study in Ontario using qualitative focus groups and quantitative surveys. 133 physicians and 94 community dwelling adults completed online surveys and we held two focus groups of nine community dwelling participants who had cardiovascular risk factors and an interest in using mHealth apps. Quantitative survey data was analyzed descriptively. Focus groups were audio-recorded and transcribed verbatim prior to inductive thematic content analysis. We integrated the results from the surveys and focus groups to understand factors that influence physicians' and patients' selection and use of such apps., Results: Physicians recommend apps to patients but the level of evidence they prefer to use to guide selection did not align with what they were currently using. Patients trusted recommendations and reviews from medical organizations and healthcare professionals when selecting apps and were motivated to continue using apps when they supported goal setting and tracking, data sharing, decision making, and empowerment., Conclusions: The findings highlight the significance of evaluating mHealth apps based on metrics that patients and physicians value beyond usage and clinical outcome data. Patients engage with apps that support them in confidently managing their health. Increased training and awareness of apps and creating a more rigorous evidence base showing the value of apps to supporting health goals will support greater adoption and acceptance of mHealth apps., Competing Interests: Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article. VB reports honoraria and an educational grant from Pfizer, honoraria from Bayer and loan of devices from Apple for research purposes., (© The Author(s) 2022.)

Background: For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes., Methods: The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients ≥45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on ≥ 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization., Discussion: Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality., Trial Registration: ClinicalTrials.gov NCT03505723. Registered on 23 April 2018., (© 2022. The Author(s).)

Frailty is an established risk factor for adverse outcomes following non-cardiac surgery. The Hospital Frailty Risk Score (HFRS) is a recently described frailty assessment tool that harnesses administrative data and is composed of 109 International Classification of Disease variables. We aimed to examine the incremental prognostic utility of the HFRS in a generalizable surgical population. Using linked administrative databases, a retrospective cohort of patients admitted for non-cardiac surgery between October 1st, 2008 and September 30th, 2019 in Alberta, Canada was created. Our primary outcome was a composite of death, myocardial infarction or cardiac arrest at 30-days. Multivariable logistic regression was undertaken to assess the impact of HFRS on outcomes after adjusting for age, sex, components of the Charlson Comorbidity Index (CCI), Revised Cardiac Risk Index (RCRI) and peri-operative biomarkers. The final cohort consisted of 712,808 non-cardiac surgeries, of which 55·1% were female and the average age was 53·4 +/- 22·4 years. Using the HFRS, 86.3% were considered low risk, 10·7% were considered intermediate risk and 3·1% were considered high risk for frailty. Intermediate and high HFRS scores were associated with increased risk of the primary outcome with an adjusted odds ratio of 1·61 (95% CI 1·50-1.74) and 1·55 (95% CI 1·38-1·73). Intermediate and high HFRS were also associated with increased adjusted odds of prolonged hospital stay, in-hospital mortality, and 1-year mortality. The HFRS is a minimally onerous frailty assessment tool that can complement perioperative risk stratification in identifying patients at high risk of short- and long-term adverse events., Competing Interests: The authors have declared that no competing interests exist.

Background: Most patients who take antihypertensive medications continue taking them on the morning of surgery and during the perioperative period. However, growing evidence suggests this practice may contribute to perioperative hypotension and a higher risk of complications. This protocol describes an acute kidney injury substudy of the Perioperative Ischemic Evaluation-3 (POISE-3) trial, which is testing the effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy in patients undergoing noncardiac surgery., Objective: To conduct a substudy of POISE-3 to determine whether a perioperative hypotension-avoidance strategy reduces the risk of acute kidney injury compared with a hypertension-avoidance strategy., Design: Randomized clinical trial with 1:1 randomization to the intervention (a perioperative hypotension-avoidance strategy) or control (a hypertension-avoidance strategy)., Intervention: If the presurgery systolic blood pressure (SBP) is <130 mmHg, all antihypertensive medications are withheld on the morning of surgery. If the SBP is ≥130 mmHg, some medications (but not angiotensin receptor blockers [ACEIs], angiotensin receptor blockers [ARBs], or renin inhibitors) may be continued in a stepwise manner. During surgery, the patients' mean arterial pressure (MAP) is maintained at ≥80 mmHg. During the first 48 hours after surgery, some antihypertensive medications (but not ACEIs, ARBs, or renin inhibitors) may be restarted in a stepwise manner if the SBP is ≥130 mmHg., Control: Patients receive their usual antihypertensive medications before and after surgery. The patients' MAP is maintained at ≥60 mmHg from anesthetic induction until the end of surgery., Setting: Recruitment from 108 centers in 22 countries from 2018 to 2021., Patients: Patients (~6800) aged ≥45 years having noncardiac surgery who have or are at risk of atherosclerotic disease and who routinely take antihypertensive medications., Measurements: The primary outcome of the substudy is postoperative acute kidney injury, defined as an increase in serum creatinine concentration of either ≥26.5 μmol/L (≥0.3 mg/dL) within 48 hours of randomization or ≥50% within 7 days of randomization., Methods: The primary analysis (intention-to-treat) will examine the relative risk and 95% confidence interval of acute kidney injury in the intervention versus control group. We will repeat the primary analysis using alternative definitions of acute kidney injury and examine effect modification by preexisting chronic kidney disease, defined as a prerandomization estimated glomerular filtration rate <60 mL/min/1.73 m 2 ., Results: Substudy results will be analyzed in 2022., Limitations: It is not possible to mask patients or providers to the intervention; however, objective measures will be used to assess acute kidney injury., Conclusions: This substudy will provide generalizable estimates of the effect of a perioperative hypotension-avoidance strategy on the risk of acute kidney injury., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2022.)

Surgical interventions can elicit neuroendocrine and sympathovagal responses, leading to cardiac autonomic imbalance. Cardiac complications account for approximately 30% of postoperative complications. Altered heart rate variability (HRV) was initially described in the 1970s as a predictor of acute coronary syndromes and has more recently been shown to be an independent predictor of postoperative morbidity and mortality after noncardiac surgery. In general, HRV reflects autonomic balance, and altered HRV measures have been associated with anesthetic use, chronic pain conditions, and experimental pain. Despite the well-documented relationship between altered HRV and postsurgical outcomes and various pain conditions, there has not been a review of available evidence describing the association between postsurgical pain and HRV. We examined the relationship between postsurgical pain and HRV. MEDLINE and EMBASE databases were searched until December 2020 and included all studies with primary data. Two reviewers independently assessed risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Review of Interventions. A total of 8 studies and 1002 participants were included. Studies examined the association of postsurgical pain and HRV or analgesia nociception index derived from HRV. There was a statistically significant association between HRV measures and postsurgical pain in 6 of 8 studies. Heterogeneity of studies precluded meta-analyses. No studies reported cardiovascular outcomes. There is a potential association between postsurgical pain and HRV or analgesia nociception index, although results are likely impacted by confounding variables. Future studies are required to better delineate the relationship between postsurgical pain and HRV and impacts on cardiovascular outcomes., Competing Interests: The authors have no conflict of interest to declare. Supported, in part, by the CIHR SPOR Chronic Pain Network.Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.)

Background: We present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer., Objective: This study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive randomized controlled trial. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context., Methods: Participants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61). Primary outcomes were rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants' positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer). The intervention and data collection took place on the web., Results: The recruitment rate was 77% (47/61). A total of 41 participants completed the baseline questionnaires and were randomized to either the IG (n=21) or the waitlist CG (n=20). The retention rate (attending all program sessions) was greater than 50% (all: 21/41, 51%, IG: 10/21, 48%; and CG: 11/20, 55%). The follow-up rate (completing all questionnaires) was greater than 80% (all: 33/41, 80%; IG: 16/21, 76%; and CG: 17/20, 85%). The completion rate (attending ≥3 sessions and completing all questionnaires) was greater than 60% (all: 25/41, 61%; IG: 13/21, 62%; and CG: 12/20, 60%). Engagement data showed that participants viewed between half (5.1/10, 51%) and three-quarters (12.2/16, 76%) of the pages in each session., Conclusions: All progression criteria for a definitive trial were met, as supported by the primary outcome data. The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation. A full-scale trial of the digital HOPE program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a CG., Trial Registration: ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250., International Registered Report Identifier (irrid): RR2-10.2196/24264., (©Hayley Wright, Faith Martin, Wendy Clyne, Cain C T Clark, Gabriela Matouskova, Michael McGillion, Andrew Turner. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 05.11.2021.)

Background: The purpose of this study was to determine the incidence, characteristics, impact, and risk factors associated with persistent incisional pain. The hypothesis was that patient demographics and perioperative interventions are associated with persistent pain., Methods: This was a secondary analysis of an international prospective cohort study from 2012 to 2014. This study included patients who were 45 yr of age or older who underwent major inpatient noncardiac surgery. Data were collected perioperatively and at 1 yr after surgery to assess for the development of persistent incisional pain (pain present around incision at 1 yr after surgery)., Results: Among 14,831 patients, 495 (3.3%; 95% CI, 3.1 to 3.6) reported persistent incisional pain at 1 yr, with an average pain intensity of 3.6 ± 2.5 (0 to 10 numeric rating scale), with 35% and 14% reporting moderate and severe pain intensities, respectively. More than half of patients with persistent pain reported needing analgesic medications, and 85% reported interference with daily activities (denominator = 495 in the above proportions). Risk factors for persistent pain included female sex (P = 0.007), Asian ethnicity (P < 0.001), surgery for fracture (P < 0.001), history of chronic pain (P < 0.001), coronary artery disease (P < 0.001), history of tobacco use (P = 0.048), postoperative patient-controlled analgesia (P < 0.001), postoperative continuous nerve block (P = 0.010), insulin initiation within 24 h of surgery (P < 0.001), and withholding nonsteroidal anti-inflammatory medication or cyclooxygenase-2 inhibitors on the day of surgery (P = 0.029 and P < 0.001, respectively). Older age (P < 0.001), endoscopic surgery (P = 0.005), and South Asian (P < 0.001), Native American/Australian (P = 0.004), and Latin/Hispanic ethnicities (P < 0.001) were associated with a lower risk of persistent pain., Conclusions: Persistent incisional pain is a common complication of inpatient noncardiac surgery, occurring in approximately 1 in 30 adults. It results in significant morbidity, interferes with daily living, and is associated with persistent analgesic consumption. Certain demographics, ethnicities, and perioperative practices are associated with increased risk of persistent pain., (Copyright © 2021, the American Society of Anesthesiologists. All Rights Reserved.)

High-quality, centre-based education and care during the early years benefit cognitive development, especially in children from disadvantaged backgrounds. During the COVID-19 pandemic and its associated lockdowns, access to early childhood education and care (ECEC) was disrupted. We investigate how this period affected the developmental advantages typically offered by ECEC. Using parent-report data from 189 families living in the UK, we explore associations between time spent in ECEC by 8-to-36-month-olds, their socioeconomic background, and their growth in language and executive functions between Spring and Winter 2020. Receptive vocabulary growth was greater in children who continued to attend ECEC during the period, with a stronger positive effect for children from less advantaged backgrounds. The growth of cognitive executive functions (CEFs) was boosted by ECEC attendance during the period, regardless of socioeconomic background. Our findings highlight the importance of high-quality ECEC for the development of key skills and for levelling socioeconomic inequalities., Competing Interests: The authors report no conflicts of interest., (© 2021 The Authors. Infant and Child Development published by John Wiley & Sons Ltd.)

Aims: Implantable cardioverter-defibrillators (ICDs) deliver therapy for life-threatening arrhythmias. Evidence suggests that ICD candidates have misconceptions regarding ICD therapy and unmet information needs. We undertook a pilot feasibility trial comparing a nurse-led educational intervention plus standard care, vs. standard pre-ICD implantation care. Secondary aims included examination of anxiety, quality of life, and shock anxiety., Methods and Results: Implantable cardioverter-defibrillator candidates were consented and randomized to standard pre-ICD implantation care vs. standard care plus a nurse-led educational intervention. The primary feasibility outcomes included: recruitment rate, consent rate, randomization rate, proportion of participants able to complete all questionnaires, time to deliver intervention, and intervention topics completion. At baseline, demographic and Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scores were collected. Four weeks post-ICD implantation, participants completed the PROMIS, Florida Patient Acceptance Survey (FPAS), and Florida Shock Anxiety Scale (FSAS). Twenty patients consented (10 per group). Feasibility targets were achieved for all but two outcomes: consent rate was 87% vs. 95% target, and completion of data collection measures was 85% vs. 90% target. Consent rate was lower than expected as one patient declined, and two could not be approached. Completion rate was lower than expected as two patients were lost to follow-up, and one did not receive an ICD during the study period, leading to incomplete post-implantation survey collections., Conclusion: The results demonstrate the feasibility of conducting a trial comparing a nurse-led pre-implantation educational intervention to standard care in an outpatient setting. Further study to evaluate the effectiveness of this intervention on patient-reported outcomes is warranted., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Introduction: Surgical interventions can elicit neuroendocrine responses and sympathovagal imbalance, ultimately affecting cardiac autonomic function. Cardiac complications account for 30% of postoperative complications and are the leading cause of morbidity and mortality following non-cardiac surgery. One cardiovascular parameter, heart rate variability (HRV), has been found to be predictive of postoperative morbidity and mortality. HRV is defined as variation in time intervals between heartbeats and is affected by cardiac autonomic balance. Furthermore, altered HRV has been shown to predict cardiovascular events in non-surgical settings. In multiple studies, experimentally induced pain in healthy humans leads to reduced HRV suggesting a causal relationship. In a different studies, chronic pain has been associated with altered HRV, however, in the setting of clinical pain conditions, it remains unclear how much HRV impairment is due to pain itself versus autonomic changes related to analgesia. We aim to review the available evidence describing the association between postsurgical pain and HRV alterations in the early postoperative period., Methods and Analysis: We will conduct a scoping review of relevant studies using detailed searches of MEDLINE and EMBASE, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Included studies will involve participants undergoing non-cardiac surgery and investigate outcomes of (1) measures of pain intensity; (2) measures of HRV and (3) statistical assessment of association between #1 and #2. As secondary review outcomes included studies will also be examined for other cardiovascular events and for their attempts to control for analgesic treatment and presurgical HRV differences among treatment groups in the analysis. This work aims to synthesise available evidence to inform future research questions related to postsurgical pain and cardiac complications., Ethics and Dissemination: Ethics review and approval is not required for this review. The results will be submitted for publication in peer-reviewed journals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

In the field of digital health research, nurse leaders have an opportunity to be integral to the design, implementation and evaluation of virtual care interventions. This case study details the experiences of two emerging nurse leaders during the COVID-19 pandemic in providing research and clinical leadership for a national virtual health trial. These nurse leaders trained and led a national team of 70 nurses across eight participating centres delivering the virtual care and remote monitoring intervention, using the normalization process theory. This case study presents a theoretically informed approach to training and leadership and discusses the experiences and lessons learned., (Copyright © 2021 Longwoods Publishing.)

Background: Timely identification of patients at a high risk of clinical deterioration is key to prioritizing care, allocating resources effectively, and preventing adverse outcomes. Vital signs-based, aggregate-weighted early warning systems are commonly used to predict the risk of outcomes related to cardiorespiratory instability and sepsis, which are strong predictors of poor outcomes and mortality. Machine learning models, which can incorporate trends and capture relationships among parameters that aggregate-weighted models cannot, have recently been showing promising results., Objective: This study aimed to identify, summarize, and evaluate the available research, current state of utility, and challenges with machine learning-based early warning systems using vital signs to predict the risk of physiological deterioration in acutely ill patients, across acute and ambulatory care settings., Methods: PubMed, CINAHL, Cochrane Library, Web of Science, Embase, and Google Scholar were searched for peer-reviewed, original studies with keywords related to "vital signs," "clinical deterioration," and "machine learning." Included studies used patient vital signs along with demographics and described a machine learning model for predicting an outcome in acute and ambulatory care settings. Data were extracted following PRISMA, TRIPOD, and Cochrane Collaboration guidelines., Results: We identified 24 peer-reviewed studies from 417 articles for inclusion; 23 studies were retrospective, while 1 was prospective in nature. Care settings included general wards, intensive care units, emergency departments, step-down units, medical assessment units, postanesthetic wards, and home care. Machine learning models including logistic regression, tree-based methods, kernel-based methods, and neural networks were most commonly used to predict the risk of deterioration. The area under the curve for models ranged from 0.57 to 0.97., Conclusions: In studies that compared performance, reported results suggest that machine learning-based early warning systems can achieve greater accuracy than aggregate-weighted early warning systems but several areas for further research were identified. While these models have the potential to provide clinical decision support, there is a need for standardized outcome measures to allow for rigorous evaluation of performance across models. Further research needs to address the interpretability of model outputs by clinicians, clinical efficacy of these systems through prospective study design, and their potential impact in different clinical settings., (©Sankavi Muralitharan, Walter Nelson, Shuang Di, Michael McGillion, PJ Devereaux, Neil Grant Barr, Jeremy Petch. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 04.02.2021.)

Background: Mobile health (mHealth) interventions can improve health by improving cardiovascular risk factors, but their adoption in care by physicians and patients is untapped. Few mHealth apps have been evaluated in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available. Given the rapid pace of change in this field, it is not feasible to rigorously evaluate mHealth apps with current methodologies., Objective: The overall aim of this pilot study was to test the feasibility of using a web research platform called Trial My App to conduct efficient and rigorous web-based randomized controlled trials (RCTs) of mHealth apps relevant to patients with cardiovascular risk factors by evaluating an app that targets hypertension., Methods: For this study, 200 participants with suboptimally controlled hypertension will be recruited through advertisements in newsletters, media, and the internet, as well as through referrals from their health care providers. Screening, consent, randomization, and collection of patient-important health confidence and self-management ability outcomes will be conducted online through the Trial My App research platform. Participants will be randomized into 2 groups: 100 that will use an mHealth app for tracking hypertension and 100 that will be considered as an educational control. All participants will complete questionnaires at 0, 1, 3 and 6 months after enrolment. A substudy to validate the method of blood pressure readings and the consistency of data entered through Trial My App will be conducted with 40 participants., Results: The development of the Trial My App web platform has been completed. The creation of survey instruments has been completed in collaboration with our patient partners and advisory board. Recruitment is expected to begin in the first quarter of 2021; data collection and analysis are expected to be completed approximately 1 year after study commencement. Results will be disseminated through conferences and publications. The primary outcomes of this study include the feasibility of conducting an RCT using the Trial My App platform by reporting recruitment, retention, and completion statistics. We will validate app-entered data with a standard 7-day home blood pressure measurement method. Lastly, the pilot, nonblinded RCT will assess the effectiveness of the mHealth app in improving the control of hypertension compared with the control of hypertension in the educational control group., Conclusions: This study will determine if it is feasible to use the Trial My App web-based platform to evaluate the effectiveness of mHealth apps for patients with cardiovascular risk factors. As more mHealth apps are evaluated in RCTs, patients will be able to select apps that meet their needs and physicians will be able to make evidence-based recommendations to their patients for apps aimed at improving cardiovascular health., Trial Registration: ClinicalTrials.gov NCT04528654; https://clinicaltrials.gov/ct2/show/NCT04528654., International Registered Report Identifier (irrid): PRR1-10.2196/26155., (©Cynthia Lokker, Rita Jezrawi, Itzhak Gabizon, Jobin Varughese, Michael Brown, Dan Trottier, Elizabeth Alvarez, Jon-David Schwalm, Michael McGillion, Jinhui Ma, Vinai Bhagirath. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.02.2021.)

Background: Perioperative myocardial injury after noncardiac surgery affects more than 10% of individuals, with increased morbidity and mortality. Perioperative cardiac risk assessment targets the identification of this high-risk population using preoperative natriuretic peptides and postoperative troponin measurements. Our objective was to assess the use of these biomarkers in the province of Alberta., Methods: A retrospective cohort of all patients who underwent noncardiac surgery in Alberta from January 2013 to December 2017 was created using linked provincial administrative databases. Inclusion criteria were modified from recommendations for perioperative cardiac screening including: patients with a Revised Cardiac Risk Index score ≥ 1 and age 65 years or older, or 45 years of age or older with history of cardiovascular disease, with planned overnight hospital stay., Results: In our cohort of 59,506 patients, only 6.8% underwent preoperative natriuretic peptide screening. Rates of appropriate preoperative natriuretic peptide testing increased marginally from 5.7% to 8.8% over the study period. Postoperative troponin was measured at least once in 19.5% of patients. Patients with elevated perioperative screening biomarkers showed increased 6-month mortality, and increased hospitalizations for heart failure and acute coronary syndromes., Conclusions: The use of biomarkers to assist in cardiac risk stratification and postoperative monitoring remains low. Addressing access to these tests and improving physician education regarding the asymptomatic nature of postoperative cardiac events might improve compliance with national guidelines., (Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: We aimed to establish diagnostic criteria for bleeding independently associated with mortality after noncardiac surgery (BIMS) defined as bleeding during or within 30 days after noncardiac surgery that is independently associated with mortality within 30 days of surgery, and to estimate the proportion of 30-day postoperative mortality potentially attributable to BIMS., Methods: This was a prospective cohort study of participants ≥45 yr old having inpatient noncardiac surgery at 12 academic hospitals in eight countries between 2007 and 2011. Cox proportional hazards models evaluated the adjusted relationship between candidate diagnostic criteria for BIMS and all-cause mortality within 30 days of surgery., Results: Of 16 079 participants, 2.0% (315) died and 36.1% (5810) met predefined screening criteria for bleeding. Based on independent association with 30-day mortality, BIMS was identified as bleeding leading to a postoperative haemoglobin <70 g L -1 , transfusion of ≥1 unit of red blood cells, or that was judged to be the cause of death. Bleeding independently associated with mortality after noncardiac surgery occurred in 17.3% of patients (2782). Death occurred in 5.8% of patients with BIMS (161/2782), 1.3% (39/3028) who met bleeding screening criteria but not BIMS criteria, and 1.1% (115/10 269) without bleeding. BIMS was associated with mortality (adjusted hazard ratio: 1.87; 95% confidence interval: 1.42-2.47). We estimated the proportion of 30-day postoperative deaths potentially attributable to BIMS to be 20.1-31.9%., Conclusions: Bleeding independently associated with mortality after noncardiac surgery (BIMS), defined as bleeding that leads to a postoperative haemoglobin <70 g L -1 , blood transfusion, or that is judged to be the cause of death, is common and may account for a quarter of deaths after noncardiac surgery., Clinical Trial Registration: NCT00512109., (Copyright © 2020 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)

Background: Diagnostic criteria for Bleeding Independently associated with Mortality after noncardiac Surgery (BIMS) have been defined as bleeding that leads to a postoperative haemoglobin <70 g L -1 , leads to blood transfusion, or is judged to be the direct cause of death. Preoperative prediction guides for BIMS can facilitate informed consent and planning of perioperative care., Methods: In a prospective cohort study of 16 079 participants aged ≥45 yr having inpatient noncardiac surgery at 12 academic hospitals in eight countries between 2007 and 2011, 17.3% (2782) experienced BIMS. An electronic risk calculator for BIMS was developed and internally validated by logistic regression with bootstrapping, and further simplified to a risk index. Decision curve analysis assessed the potential utility of each prediction guide compared with a strategy of identifying risk of BIMS based on preoperative haemoglobin <120 g L -1 ., Results: With information about the type of surgery, preoperative haemoglobin, age, sex, functional status, kidney function, history of high-risk coronary artery disease, and active cancer, the risk calculator accurately predicted BIMS (bias-corrected C-statistic, 0.84; 95% confidence interval, 0.837-0.852). A simplified index based on preoperative haemoglobin <120 g L -1 , open surgery, and high-risk surgery also predicted BIMS, but less accurately (C-statistic, 0.787; 95% confidence interval, 0.779-0.796). Both prediction guides could improve decision making compared with knowledge of haemoglobin <120 g L -1 alone., Conclusions: BIMS, defined as bleeding that leads to a postoperative haemoglobin <70 g L -1 , leads to blood transfusion, or that is judged to be the direct cause of death, can be predicted by a simple risk index before surgery., Clinical Trial Registration: NCT00512109., (Copyright © 2020 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)

Background: During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies., Objective: We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being., Methods: Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram., Results: All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020., Conclusions: This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times., Trial Registration: ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250., International Registered Report Identifier (irrid): DERR1-10.2196/24264., (©Hayley Wright, Faith Martin, Wendy Clyne, Cain C T Clark, Michael McGillion, Gabriela Matouskova, Andrew Turner. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 04.12.2020.)

The interplay of virtual care and cancer care in the context of the COVID-19 pandemic is unique and unprecedented. Patients with cancer are at increased risk of SARS-CoV-2 infection and have worse outcomes than patients with COVID-19 who do not have cancer. Virtual care has been introduced quickly and extemporaneously in cancer treatment centers worldwide to maintain COVID-19-free zones. The outbreak of COVID-19 in a cancer center could have devastating consequences. The virtual care intervention that was first used in our cancer center, as well as many others, was a landline telephone in an office or clinic that connected a clinician with a patient. There is a lack of virtual care evaluation from the perspectives of patients and oncology health care providers. A number of factors for assessing oncology care delivered through a virtual care intervention have been described, including patient rapport, frailty, delicate conversations, team-based care, resident education, patient safety, technical effectiveness, privacy, operational effectiveness, and resource utilization. These factors are organized according to the National Quality Forum framework for the assessment of telehealth in oncology. This includes the following 4 domains of assessing outcomes: experience, access to care, effectiveness, and financial impact or cost. In terms of virtual care and oncology, the pandemic has opened the door to change. The lessons learned during the initial period of the pandemic have given rise to opportunities for the evolution of long-term virtual care. The opportunity to evaluate and improve virtual care should be seized upon., (©Oren Hannun Levine, Michael McGillion, Mark Levine. Originally published in JMIR Cancer (http://cancer.jmir.org), 24.11.2020.)

Background: Primary percutaneous coronary intervention is used to restore blood flow in the infarct-related coronary artery, followed by immediate stenting to prevent reocclusion. Stents implanted in thrombus-laden arteries cause distal embolization, which paradoxically impairs myocardial reperfusion and ventricular function. Whether a strategy of delayed stenting improves outcomes in patients with acute ST-elevation myocardial infarction (STEMI) is uncertain., Methods: The Primary Reperfusion Secondary Stenting (PRIMACY) is a Bayesian prospective, randomized, open-label, blinded end point trial in which delayed vs immediate stenting in patients with STEMI were compared for prevention of cardiovascular death, nonfatal myocardial infarction, heart failure, or unplanned target vessel revascularization at 9 months. All participants were immediately reperfused, but those assigned to the delayed arm underwent stenting after an interval of 24 to 48 hours. This interval was bridged with antithrombin therapy to reduce thrombus burden. In the principal Bayesian hierarchical random effects analysis, data from exchangeable trials will be combined into a study prior and updated with PRIMACY into a posterior probability of efficacy., Results: A total of 305 participants were randomized across 15 centres in France and Canada between April 2014 and September 2017. At baseline, the median age of participants was 59 years, 81% were male, and 3% had a history of percutaneous coronary intervention. Results from PRIMACY will be updated from the patient-level data of 1568 participants enrolled in the Deferred Stent Trial in STEMI (DEFER; United Kingdom), Minimalist Immediate Mechanical Intervention (MIMI; France), Danish Trial in Acute Myocardial Infarction-3 (DANAMI-3; Denmark), and Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST Segment-Elevation Myocardial Infarction (INNOVATION, South Korea) trials., Conclusions: We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI., (Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: The prevalence and intensity of persistent post-surgical pain (PPSP) after breast cancer surgery are uncertain. We conducted a systematic review and meta-analysis to further elucidate this issue., Methods: We searched MEDLINE, Embase, CINAHL, and PsycINFO, from inception to November 2018, for observational studies reporting persistent pain (≥3 months) after breast cancer surgery. We used random-effects meta-analysis and the Grading of Recommendations, Assessment, Development and Evaluations approach to rate quality of evidence., Results: We included 187 observational studies with 297 612 breast cancer patients. The prevalence of PPSP ranged from 2% to 78%, median 37% (inter-quartile range: 22-48%); the pooled prevalence was 35% (95% confidence interval [CI]: 32-39%). The pooled pain intensity was 3.9 cm on a 10 cm visual analogue scale (95% CI: 3.6-4.2 cm). Moderate-quality evidence supported the subgroup effects of PPSP prevalence for localized pain vs any pain (29% vs 44%), moderate or greater vs any pain (26% vs 44%), clinician-assessed vs patient-reported pain (23% vs 36%), and whether patients underwent sentinel lymph node biopsy vs axillary lymph node dissection (26% vs 43%). The adjusted analysis found that the prevalence of patient-reported PPSP (any severity/location) was 46% (95% CI: 36-56%), and the prevalence of patient-reported moderate-to-severe PPSP at any location was 27% (95% CI: 10-43%)., Conclusions: Moderate-quality evidence suggests that almost half of all women undergoing breast cancer surgery develop persistent post-surgical pain, and about one in four develop moderate-to-severe persistent post-surgical pain; the higher prevalence was associated with axillary lymph node dissection. Future studies should explore whether nerve sparing for axillary procedures reduces persistent post-surgical pain after breast cancer surgery., (Copyright © 2020 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)

Background: People living with cancer face numerous psychosocial challenges, including cancer-related fatigue, fear of recurrence, and depression. There is a lack of digital interventions tailored to the needs of people living with all types of cancer. We developed a 6-week, digital, peer-delivered, self-management program: iHOPE (Help to Overcome Problems Effectively; where 'i' indicates the digital version of the program). The program is underpinned by positive psychology and cognitive behavioral therapy to meet these psychosocial challenges., Objective: This study aimed to assess the feasibility of the iHOPE program among people living with cancer. Program adherence and satisfaction along with changes in psychological distress and positive well-being were measured., Methods: A pre-post, acceptability, and feasibility design was used. People living with cancer (N=114) were recruited via a national cancer charity in the United Kingdom and were given access to the iHOPE program. Demographic and other participant characteristics were recorded. Participants completed digital measures at baseline and the end of the 6-week program for depression, anxiety, cancer-related fatigue, cancer worry or fear of cancer recurrence, positive mental well-being, hope, gratitude, and health status. The website's system recorded data on the usage of the program. Satisfaction with the program was also measured., Results: A total of 114 participants completed the baseline questionnaires. Of these, 70 people (61.4%) participated in all 6 sessions. The mean number of sessions undertaken was 5.0 (SD 1.5). Moreover, 44.7% (51/114) of participants completed at least three sessions and end-of-program outcome measures. A total of 59 participants completed the satisfaction questionnaire, where ≥90% (54/58) of participants reported that the program was easy to navigate and was well managed by the peer facilitators, and that they found the social networking tools useful. Preliminary efficacy testing among the 51 participants who completed baseline and postprogram outcome measures showed that postprogram scores decreased for depression, anxiety, cancer-related fatigue, and fear of recurrence (all P<.001) and increased for positive mental well-being (P<.001), hope (both P<.001), and gratitude (P=.02)., Conclusions: The feasibility evidence is promising, showing that the peer-delivered digital iHOPE program is acceptable and practical. Implementation of the iHOPE program on a wider scale will incorporate further research and development to maximize the completion rates of the measures. Initial effectiveness data suggest positive impacts on important cancer-related quality of life and mental well-being outcomes. A randomized controlled trial design with a longer follow-up is needed to confirm the potential of the iHOPE program for improving mental and physical health outcomes for cancer survivors., (©Faith Martin, Hayley Wright, Louise Moody, Becky Whiteman, Michael McGillion, Wendy Clyne, Gemma Pearce, Andy Turner. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 19.05.2020.)

The ability to make inferences is essential for effective language comprehension. While inferencing training benefits reading comprehension in school-aged children (see Elleman, 2017, for a review), we do not yet know whether it is beneficial to support the development of these skills prior to school entry. In a pre-registered randomised controlled trial, we evaluated the efficacy of a parent-delivered intervention intended to promote four-year-olds' oral inferencing skills during shared book-reading. One hundred children from socioeconomically diverse backgrounds were randomly assigned to inferencing training or an active control condition of daily maths activities. The training was found to have no effect on inferencing. However, inferencing measures were highly correlated with children's baseline language ability. This suggests that a more effective approach to scaffolding inferencing in the preschool years might be to focus on promoting vocabulary to develop richer and stronger semantic networks.

Background: Cardiac and major vascular surgeries are common surgical procedures associated with high rates of postsurgical complications and related hospital readmission. In-hospital remote automated monitoring (RAM) and virtual hospital-to-home patient care systems have major potential to improve patient outcomes following cardiac and major vascular surgery. However, the science of deploying and evaluating these systems is complex and subject to risk of implementation failure., Objective: As a precursor to a randomized controlled trial (RCT), this user testing study aimed to examine user performance and acceptance of a RAM and virtual hospital-to-home care intervention, using Philip's Guardian and Electronic Transition to Ambulatory Care (eTrAC) technologies, respectively., Methods: Nurses and patients participated in systems training and individual case-based user testing at two participating sites in Canada and the United Kingdom. Participants were video recorded and asked to think aloud while completing required user tasks and while being rated on user performance. Feedback was also solicited about the user experience, including user satisfaction and acceptance, through use of the Net Promoter Scale (NPS) survey and debrief interviews., Results: A total of 37 participants (26 nurses and 11 patients) completed user testing. The majority of nurse and patient participants were able to complete most required tasks independently, demonstrating comprehension and retention of required Guardian and eTrAC system workflows. Tasks which required additional prompting by the facilitator, for some, were related to the use of system features that enable continuous transmission of patient vital signs (eg, pairing wireless sensors to the patient) and assigning remote patient monitoring protocols. NPS scores by user group (nurses using Guardian: mean 8.8, SD 0.89; nurses using eTrAC: mean 7.7, SD 1.4; patients using eTrAC: mean 9.2, SD 0.75), overall NPS scores, and participant debrief interviews indicated nurse and patient satisfaction and acceptance of the Guardian and eTrAC systems. Both user groups stressed the need for additional opportunities to practice in order to become comfortable and proficient in the use of these systems., Conclusions: User testing indicated a high degree of user acceptance of Philips' Guardian and eTrAC systems among nurses and patients. Key insights were provided that informed refinement of clinical workflow training and systems implementation. These results were used to optimize workflows before the launch of an international RCT of in-hospital RAM and virtual hospital-to-home care for patients undergoing cardiac and major vascular surgery., (©Michael Hugh McGillion, Carley Ouellette, Amber Good, Marissa Bird, Shaunattonie Henry, Wendy Clyne, Andrew Turner, Paul Ritvo, Sarah Ritvo, Nazari Dvirnik, Andre Lamy, Richard Whitlock, Christopher Lawton, Jake Walsh, Ken Paterson, Janine Duquette, Karla Sanchez Medeiros, Fadi Elias, Ted Scott, Joseph Mills, Deborah Harrington, Mark Field, Prathiba Harsha, Stephen Yang, Elizabeth Peter, Sanjeev Bhavnani, PJ Devereaux. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 18.03.2020.)

Introduction: More women experience cardiac pain related to coronary artery disease and cardiac procedures compared with men. The overall goal of this programme of research is to develop an integrated smartphone and web-based intervention (HEARTPA♀N) to help women recognise and self-manage cardiac pain., Methods and Analysis: This protocol outlines the mixed methods strategy used for the development of the HEARTPA♀N content/core feature set (phase 2A), usability testing (phase 2B) and evaluation with a pilot randomised controlled trial (RCT) (phase 3). We are using the individual and family self-management theory, mobile device functionality and pervasive information architecture of mHealth interventions, and following a sequential phased approach recommended by the Medical Research Council to develop HEARTPA♀N. The phase 3 pilot RCT will enable us to refine the prototype, inform the methodology and calculate the sample size for a larger multisite RCT (phase 4, future work). Patient partners have been actively involved in setting the HEARTPA♀N research agenda, including defining patient-reported outcome measures for the pilot RCT: pain and health-related quality of life (HRQoL). As such, the guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols (SPIRIT-PRO) are used to report the protocol for the pilot RCT (phase 3). Quantitative data (eg, demographic and clinical information) will be summarised using descriptive statistics (phases 2AB and 3) and a content analysis will be used to identify themes (phase 2AB). A process evaluation will be used to assess the feasibility of the implementation of the intervention and a preliminary efficacy evaluation will be undertaken focusing on the outcomes of pain and HRQoL (phase 3)., Ethics and Dissemination: Ethics approval was obtained from the University of Toronto (36415; 26 November 2018). We will disseminate knowledge of HEARTPA♀N through publication, conference presentation and national public forums (Café Scientifique), and through fact sheets, tweets and webinars., Trial Registration Number: NCT03800082., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)