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Aims To evaluate the impact of multiple arterial grafting (MAG) vs. single arterial grafting (SAG) in a post hoc analysis of 10-year outcomes in patients with diabetes mellitus (DM) from the Arterial Revascularization Trial (ART). Methods and results The primary endpoint was all-cause mortality and the secondary endpoint was a composite of major adverse cardiac events (MACE) at 10-year follow-up. Patients were stratified by diabetes status (non-DM and DM) and grafting strategy (MAG vs. SAG). A total of 3020 patients were included in the analysis; 716 (23.7%) had DM. Overall, 55.8% non-DM patients received MAG and 44.2% received SAG, while 56.6% DM patients received MAG and 43.4% received SAG. The use of MAG compared with SAG was associated with lower 10-year mortality for both non-DM [17.7 vs. 21.0%, adjusted hazard ratio (HR) 0.87, 95% confidence interval (CI) 0.72–1.06] and DM patients (21.5 vs. 29.9%, adjusted HR 0.65, 95% CI 0.48–0.89; P for interaction = 0.12). For both groups, the rate of 10-year MACE was also lower for MAG vs. SAG. Overall, deep sternal wound infections (DSWIs) were uncommon but more frequent in the MAG vs. SAG group in both non-DM (3.3 vs. 2.1%) and DM patients (7.9 vs. 4.8%). The highest rates of DSWI were in insulin-treated patients receiving MAG (9.6 vs. 6.3%, when compared with SAG). Conclusion In this post hoc analysis of the ART, MAG was associated with substantially lower mortality rates at 10 years after coronary artery bypass grafting in patients with DM. Patients with DM receiving MAG had a higher incidence of DSWI, especially if insulin dependent.

BACKGROUND Early Warning Scores (EWS) are commonly used in hospitals to assess a patient’s risk of deterioration. EWS are traditionally recorded on paper observation charts but are increasingly recorded digitally. In either case, evidence for the clinical effectiveness of such scores is mixed. OBJECTIVE We examine whether the introduction of a digital Early Warning Score (EWS) system was associated with more frequent observation of patients with abnormal vital signs, a precursor to earlier clinical intervention. METHODS We conducted a two-armed stepped-wedge study from February 2015-December 2016, over four hospitals in one UK hospital trust. In the control arm, vital signs were recorded using paper observation charts. In the intervention arm, a digital EWS system was used. The primary outcome measure was Time To Next Observation (TTNO), defined as the time between a patient’s first elevated EWS (EWS ≥ 3) and subsequent observations set. Secondary outcomes were time to death in hospital, length of stay, and time to unplanned ICU admission. Differences between the two arms were analysed using a mixed effects Cox model. RESULTS The median TTNO in the control and intervention arms were 128 minutes (IQR: 73-218) and 131 minutes (IQR: 73-223), respectively. The corresponding hazard ratio for TTNO was 0.99 (95% CI: 0.91 - 1.07, P = .73). CONCLUSIONS There were no significant difference in the primary and secondary outcomes, despite evidence of strong clinical engagement with the system. One possible explanation is that the system did not provide sufficient or timely enough feedback to effect changes to clinical decision making. Our findings contrast with previous claims that digital EWS systems are associated with improvement in clinical outcomes. Future research should investigate the causal mechanisms by which such systems alter staff behaviours and patient outcomes.

Outcomes following endovascular thrombectomy (EVT) for large vessel occlusion stroke remain variable. Clinical predictors include presenting NIHSS and age, surrogate metrics of stroke severity and pre-stroke brain health, respectively. Imaging biomarkers can also predict outcome, but prognostic models typically only include biomarkers of acute stroke severity. This study aimed at exploring how incorporating both imaging biomarkers of stroke severity and brain frailty, automatically derived from routine imaging, impacts outcome prediction following successful EVT. In this single-center retrospective study of 215 patients presenting with anterior circulation stroke, we evaluated prognostic significance of automated analysis outputs from e-Stroke. Acute ischemic volume (AIV) and e-ASPECTS were used to define stroke severity. Cerebral atrophy was used as a marker of brain frailty. Models incorporating imaging biomarkers, clinical features, procedural factors, and combinations of these were evaluated using multivariate regression models predicting mRS 0-2 at 30 and 90-days, NIHSS improvement, mortality and sICH. Incorporation of brain atrophy into models negated the effect of age on patient outcome. The interaction of stroke severity with age was similar to that of infarct volume and brain atrophy. Models incorporating age, presenting NIHSS, AIV, atrophy, reperfusion status and time to recanalization outperformed clinical models at predicting NIHSS improvement (ROC AUC 0.81 and 0.57, respectively) and 90-day mRS. Combinations of imaging and clinical features were superior for predicting any outcome compared with clinical or imaging features in isolation. Models incorporating automated image analysis of acute infarct volume and atrophy outperform models based solely on clinical characteristics for predicting short- and long-term outcome following EVT. Atrophy as a marker of brain frailty is associated with poorer long-term outcomes and negates the effect of age in multivariate models. AIV tempers the effect of intervention on early neurological improvement. Better understanding the relationship between stroke severity and baseline health status may improve patient selection strategies for reperfusion therapies.

Purpose New onset atrial fibrillation (NOAF) in critically ill patients has been associated with increased short-term mortality. Analyses that do not take into account the time-varying nature of NOAF can underestimate its association with hospital outcomes. We investigated the prognostic association of NOAF with hospital outcomes using competing risks methods. Materials and methods We undertook a retrospective cohort study in three general adult intensive care units (ICUs) in the UK from June 2008 to December 2015. We excluded patients with known prior atrial fibrillation or an arrhythmia within four hours of ICU admission. To account for the effect of NOAF on the rate of death per unit time and the rate of discharge alive per unit time we calculated subdistribution hazard ratios (SDHRs). Results Of 7541 patients that fulfilled our inclusion criteria, 831 (11.0%) developed NOAF during their ICU admission. NOAF was associated with an increased duration of hospital stay (CSHR 0.68 (95% CI 0.63–0.73)) and an increased rate of in-hospital death per unit time (CSHR 1.57 (95% CI 1.37–1.1.81)). This resulted in a strong prognostic association with dying in hospital (adjusted SDHR 2.04 (1.79–2.32)). NOAF lasting over 30 min was associated with increased hospital mortality. Conclusions Using robust methods we demonstrate a stronger prognostic association between NOAF and hospital outcomes than previously reported.

Objective: To estimate normal ranges for maternal vital signs throughout pregnancy, which have not been well defined in a large contemporary population. Methods: We conducted a three-center, prospective, longitudinal cohort study in the United Kingdom from August 2012 to September 2017. We recruited women at less than 20 weeks of gestation without significant comorbidities with accurately dated singleton pregnancies. We measured participants' blood pressure (BP), heart rate, respiratory rate, oxygen saturation and temperature following standardized operating procedures at 4–6 weekly intervals throughout pregnancy. Results: We screened 4,279 pregnant women, 1,041 met eligibility criteria and chose to take part. Systolic and diastolic BP decreased slightly from 12 weeks of gestation: median or 50th centile (3rd–97th centile) 114 (95–138); 70 (56–87) mm Hg to reach minimums of 113 (95–136); 69 (55–86) mm Hg at 18.6 and 19.2 weeks of gestation, respectively, a change (95% CI) of −1.0 (−2 to 0); −1 (−2 to −1) mm Hg. Systolic and diastolic BP then rose to a maximum median (3rd–97th centile) of 121 (102–144); 78 (62–95) mm Hg at 40 weeks of gestation, a difference (95% CI) of 7 (6–9) and9 (8–10) mm Hg, respectively. The median (3rd–97th centile) heart rate was lowest at 12 weeks of gestation: 82 (63–105) beats per minute (bpm), rising progressively to a maximum of 91 (68–115) bpm at 34.1 weeks. SpO2 decreased from 12 weeks of gestation: median (3rd–97th centile) 98% (94–99%) to 97% (93–99%) at 40 weeks. The median (3rd–97th centile) respiratory rate at 12 weeks of gestation was 15 (9–22), which did not change with gestation. The median (3rd–97th centile) temperature at 12 weeks of gestation was 36.7 (35.6–37.5)°C, decreasing to a minimum of 36.5 (35.3–37.3)°C at 33.4 weeks. Conclusion: We present widely relevant, gestation-specific reference ranges for detecting abnormal BP, heart rate, respiratory rate, oxygen saturation and temperature during pregnancy. Our findings refute the existence of a clinically significant BP drop from 12 weeks of gestation. Clinical Trial Registration: ISRCTN, ISRCTN10838017.

Supplemental Digital Content is available in the text., Objectives: Prolonged admissions to an ICU are associated with high resource utilization and personal cost to the patient. Previous reports suggest increasing length of stay may be associated with poor outcomes. Conditional survival represents the probability of future survival after a defined period of treatment on an ICU providing a description of how prognosis evolves over time. Our objective was to describe conditional survival as length of ICU stay increased. Design: Retrospective observational cohort study of three large intensive care databases. Setting: Three intensive care databases, two in the United States (Medical Information Mart for Intensive Care III and electronic ICU) and one in United Kingdom (Post Intensive Care Risk-Adjusted Alerting and Monitoring). Patients: Index admissions to intensive care for patients 18 years or older. Interventions: None. Measurements and Main Results: A total of 11,648, 38,532, and 165,125 index admissions were analyzed from Post Intensive Care Risk-Adjusted Alerting and Monitoring, Medical Information Mart for Intensive Care III and electronic ICU databases respectively. In all three cohorts, conditional survival declined over the first 5–10 days after ICU admission and changed little thereafter. In patients greater than or equal to 75 years old conditional survival continued to decline with increasing length of stay. Conclusions: After an initial period of 5–10 days, probability of future survival does not decrease with increasing length of stay in unselected patients admitted to ICUs. These findings were consistent between the three populations and suggest that a prolonged admission to an ICU is not a reason for a pessimism in younger patients but may indicate a poor prognosis in the older population.

Background There is level 1 evidence for cerebral thrombectomy with thrombolysis in acute large vessel occlusion. Many hospitals are now contemplating setting up this life-saving service. For the hospital, however, the first treatment is associated with an initial high cost to cover the procedure. Whilst the health economic benefit of treating stroke is documented, this is the only study to date performing matched-pair, patient-level costing to determine treatment cost within the first hospital episode and up to 90 days post-event. Methods We conducted a retrospective coarsened exact matched-pair analysis of 50 acute stroke patients eligible for thrombectomy. Results Thrombectomy resulted in significantly more good outcomes (mRS 0–2) compared to matched controls (56% vs 8%, p = 0.001). More patients in the thrombectomy group could be discharged home (60% vs 28%), fewer were discharged to nursing homes (4% vs 16%), residential homes (0% vs 12%) or rehabilitation centres (8% vs 20%). Thrombectomy patients had fewer serious adverse events (n = 30 vs 86) and were, on average, discharged 36 days earlier. They required significantly fewer physiotherapy sessions (18.72 vs 46.49, p = 0.0009) resulting in a median reduction in total rehabilitation cost of £4982 (p = 0.0002) per patient. The total cost of additional investigations was £227 lower (p = 0.0369). Overall, the median cost without thrombectomy was £39,664 per case vs £22,444, resulting in median savings of £17,221 (p = 0.0489). Conclusions Mechanical thrombectomy improved patient outcome, reduced length of hospitalisation and, even without procedural reimbursement, significantly reduced cost to the thrombectomy providing hospital.

We aimed to generate a model to predict the risk of a woman having normal, abnormally adherent (AAP) or abnormally invasive placentation (AIP) based on the presence of recently codified ultrasound (US) markers and disease definitions of placenta accreta spectrum (PAS). We recruited women with anterior low-lying placenta or placenta previa and a history of previous caesarean delivery to a prospective cohort study. US markers of abnormal placentation were recorded on a standardized pro forma. The presence and International Federation of Gynecology and Obstetrics grade of PAS was evaluated clinically and histologically at delivery. Markers demonstrating a predictive relationship to PAS were incorporated into a logistic regression model. A total of 106 women were included, of whom 42 (40%) were normal, 24 (23%) had AAP and 40 (38%) had AIP. A model including just four key variables (loss of clear zone, abnormal placental lacunae, placental bulge and bladder wall interruption) was shown to reliably predict presence and severity of PAS, with an optimism-corrected C-index of 0.901. A simple model incorporating four US markers can predict likelihood and severity of PAS with high accuracy. This is the first time this has been demonstrated using the recently codified definitions of the US signs and disease definitions. Further work will see our model applied prospectively to a large patient cohort, ideally through a smartphone-based application, for external validation.

BackgroundDespite the exponential growth of wearable technology, previous research indicates a lack of statistically significant evidence to support the hypothesis that implementation of wearable ambulatory vital sign monitoring systems impact early patient deterioration detection and clinical outcomes. This highlights the need for large, rigorous studies to address this gap. The objective of this feasibility trial is to assess the impact of an ambulatory monitoring system (AMS) on deterioration detection and clinical outcomes in hospitalised patients, compared to standard care. As a secondary objective we will assess the feasibility of conducting a full randomised controlled trial (RCT).MethodsBetween 120 and 240 patients will be recruited and randomised equally to either an AMS or standard care group. Wearable devices will include a pulse oximeter (monitoring pulse rate and oxygen saturation), a chest patch (monitoring heart rate, respiratory rate and temperature) and a wireless blood pressure cuff (monitoring systolic and diastolic blood pressure). Both groups will wear the devices during their ward length of stay, however only data and alerts from the AMS group will be visible to clinical staff.DiscussionRecruitment of participants is expected to start in January 2022, with an anticipated completion date of December 2022. This feasibility RCT will test the early impact of our AMS implementation in a non-intensive care ward and provide data to support the design and deployment of a full RCT which will provide much-needed evidence of the impact of AMS on early deterioration detection and clinical outcomes.

Purpose We performed a systematic review and meta-analysis to investigate the long-term outcomes of patients who develop new-onset atrial fibrillation (NOAF) during an intensive care unit (ICU) admission. Methods We searched the MEDLINE and EMBASE databases from 2000 to 2022. We included studies of adults based in general ICUs that evaluated long-term outcomes (at least 30 days after hospital discharge) of NOAF. We excluded studies involving patients with a history of atrial fibrillation (AF). We performed risk of bias assessment of the included studies based on a modified Newcastle Ottawa score (NOS). We extracted summary data for long-term outcomes. Where the outcome was reported in three or more studies we pooled effect sizes. Results We screened 2206 studies and included 15 studies reporting data from 561,797 patients. Pooled analysis of 4 studies using a random effects model revealed an association between NOAF acquired in an ICU and 90-day mortality (including ICU and hospital mortality) (RR 1.53, 95% CI 1.12–2.08). We also found an association between NOAF and 1-year mortality from 7 studies (RR 1.79, 95% CI 1.65–1.96), which remained when analysing 1-year mortality in hospital survivors (RR 1.72 (95% CI 1.49–1.98). Conclusions In patients who develop NOAF in an ICU, both 90-day and 1-year mortality are increased in comparison to those who do not develop NOAF. Current evidence suggests an increased risk of thromboembolic events after hospital discharge in patients who develop NOAF in an ICU.

Importance Recent evidence has suggested that skeletonization of the internal thoracic artery (ITA) is associated with worse clinical outcomes in patients undergoing coronary artery bypass surgery (CABG). Objective To compare the long-term clinical outcomes of skeletonized and pedicled ITA for CABG. Design, Setting, and Participants The Arterial Revascularization Trial (ART) was a 2-group, multicenter trial comparing the use of a bilateral ITA vs a single ITA for CABG at 10 years. Patients in the ART trial were stratified by ITA harvesting technique: skeletonized vs pedicled. Data were collected from June 2004 to December 2017, and data were analyzed from June to July 2021. Interventions In this analysis, the 10-year clinical outcomes were compared between patients who received skeletonized vs pedicled ITAs. Main Outcomes and Measures The primary outcome was all-cause mortality. The secondary outcomes were a composite of major adverse cardiac events (MACE) including all-cause mortality, myocardial infarction, and repeated revascularization and a composite including MACE and sternal wound complication (SWC). Cox regression and propensity score matching were used. Results Of 2161 included patients, 295 (13.7%) were female, and the median (interquartile range) age was 65.0 (58.0-70.0) years. At 10 years, the risk of all-cause mortality was not significantly different between the pedicled and skeletonized groups (hazard ratio [HR], 1.12; 95% CI, 0.92-1.36;P = .27). However, the long-term risks of the secondary outcomes were significantly higher in the skeletonized group compared with the pedicled group (MACE: HR, 1.25; 95% CI, 1.06-1.47;P = .01; MACE and SWC: HR, 1.22; 95% CI, 1.05-1.43;P = .01). The difference was not seen when considering only patients operated on by surgeons who enrolled 51 patients or more in the trial (MACE: HR, 1.07; 95% CI, 0.82-1.39;P = .62; MACE and SWC: HR, 1.04; 95% CI, 0.80-1.34;P = .78). Conclusions and Relevance While the long-term survival of patients was not different between groups, the rate of adverse cardiovascular events was consistently higher in the skeletonized group and the difference was associated with surgeon-related factors. Further evidence on the outcome of skeletonized ITA is needed.

BackgroundTimely recognition of the deteriorating inpatient remains challenging. Wearable monitoring systems (WMS) may augment current monitoring practices. However, there are many barriers to implementation in the hospital environment, and evidence describing the clinical impact of WMS on deterioration detection and patient outcome remains unclear.ObjectiveTo assess the impact of vital-sign monitoring on detection of deterioration and related clinical outcomes in hospitalised patients using WMS, in comparison with standard care.MethodsA systematic search was conducted in August 2020 using MEDLINE, Embase, CINAHL, Cochrane Database of Systematic Reviews, CENTRAL, Health Technology Assessment databases and grey literature. Studies comparing the use of WMS against standard care for deterioration detection and related clinical outcomes in hospitalised patients were included. Deterioration related outcomes (primary) included unplanned intensive care admissions, rapid response team or cardiac arrest activation, total and major complications rate. Other clinical outcomes (secondary) included in-hospital mortality and hospital length of stay. Exploratory outcomes included alerting system parameters and clinical trial registry information.ResultsOf 8706 citations, 10 studies with different designs met the inclusion criteria, of which 7 were included in the meta-analyses. Overall study quality was moderate. The meta-analysis indicated that the WMS, when compared with standard care, was not associated with significant reductions in intensive care transfers (risk ratio, RR 0.87; 95% confidence interval, CI 0.66–1.15), rapid response or cardiac arrest team activation (RR 0.84; 95% CI 0.69–1.01), total (RR 0.77; 95% CI 0.44–1.32) and major (RR 0.55; 95% CI 0.24–1.30) complications prevalence. There was also no statistically significant association with reduced mortality (RR 0.48; 95% CI 0.18–1.29) and hospital length of stay (mean difference, MD − 0.09; 95% CI − 0.43 to 0.44).ConclusionThis systematic review indicates that there is no current evidence that implementation of WMS impacts early deterioration detection and associated clinical outcomes, as differing design/quality of available studies and diversity of outcome measures make it difficult to reach a definite conclusion. Our narrative findings suggested that alarms should be adjusted to minimise false alarms and promote rapid clinical action in response to deterioration.PROSPERO Registration number:CRD42020188633.

Background: Timely recognition of the deteriorating inpatient remains challenging. Ambulatory monitoring systems (AMS) may augment current monitoring practices. However, there are many challenges to implementation in the hospital environment, and evidence describing the clinical impact of AMS on deterioration detection and patient outcome remains unclear. Objective: To assess the impact of vital signs monitoring on detection of deterioration and related clinical outcomes in hospitalised patients using ambulatory monitoring systems, in comparison with standard care.Methods: A systematic search was conducted in August 2020 using MEDLINE, Embase, CINAHL, Cochrane Database of Systematic Reviews, CENTRAL and Health Technology Assessment databases, as well as grey literature. Studies comparing the use of AMS against standard care for deterioration detection and related clinical outcomes in hospitalised patients were included. Deterioration related outcomes (primary) included unplanned intensive care admissions, rapid response team or cardiac arrest activation, total and major complications rate. Other clinical outcomes (secondary) included in-hospital mortality and hospital length of stay. Exploratory outcomes included alerting system parameters and clinical trial registry information. Results: Of 8706 citations, 10 studies with different designs met the inclusion criteria, of which 7 were included in the meta-analyses. Overall study quality was moderate. The meta-analysis indicated that the AMS, when compared with standard care, was associated with a reduction in intensive care transfers (risk ratio, RR, 0.87; 95% confidence interval, CI, 0.66 to 1.15), rapid response or cardiac arrest team activation (RR, 0.84; 95% CI 0.69 to 1.01), total (RR, 0.77; 95% CI 0.44 to 1.32) and major (RR, 0.55; 95% CI 0.24 to 1.30) complications prevalence. There was also association with reduced mortality (RR, 0.48; 95% CI 0.18 to 1.29) and hospital length of stay (mean difference, MD, -0.09; 95% CI -0.43 to 0.44). However, none were statistically significant.Conclusion: This systematic review indicates that implementation of AMS may have a positive impact on early deterioration detection and associated clinical outcomes, but differing design/quality of available studies and diversity of outcomes measures limits a definite conclusion. Our narrative findings suggested that alarms should be adjusted to minimise false alerts and promote rapid clinical action in response to deterioration.PROSPERO Registration number: CRD42020188633

Background Pleural infection is a common and severe disease with high morbidity and mortality worldwide. The knowledge of pleural infection bacteriology remains incomplete, as pathogen detection methods based on culture have insufficient sensitivity and are biased to selected microbes. We designed a study with the aim to discover and investigate the total microbiome of pleural infection and assess the correlation between bacterial patterns and 1-year survival of patients. Methods We assessed 243 pleural fluid samples from the PILOT study, a prospective observational study on pleural infection, with 16S rRNA next generation sequencing. 20 pleural fluid samples from patients with pleural effusion due to a non-infectious cause and ten PCR-grade water samples were used as controls. Downstream analysis was done with the DADA2 pipeline. We applied multivariate Cox regression analyses to investigate the association between bacterial patterns and 1-year survival of patients with pleural infection. Findings Pleural infection was predominately polymicrobial (192 [79%] of 243 samples), with diverse bacterial frequencies observed in monomicrobial and polymicrobial disease and in both community-acquired and hospital-acquired infection. Mixed anaerobes and other Gram-negative bacteria predominated in community-acquired polymicrobial infection whereas Streptococcus pneumoniae prevailed in monomicrobial cases. The presence of anaerobes (hazard ratio 0·46, 95% CI 0·24–0·86, p=0·015) or bacteria of the Streptococcus anginosus group (0·43, 0·19–0·97, p=0·043) was associated with better patient survival, whereas the presence (5·80, 2·37–14·21, p Interpretation Pleural infection is a predominantly polymicrobial infection, explaining the requirement for broad spectrum antibiotic cover in most individuals. High mortality infection associated with S aureus and Enterobacteriaceae favours more aggressive, with a narrower spectrum, antibiotic strategies. Funding UK Medical Research Council, National Institute for Health Research Oxford Biomedical Research Centre, Wellcome Trust, Oxfordshire Health Services Research Committee, Chinese Academy of Medical Sciences, and John Fell Fund.

Introduction Arterial graft physiology influences the long‐term outcome of coronary artery bypass grafting (CABG). We studied factors that can affect the overall resistance to flow using internal mammary artery grafting to the left anterior descending artery. Methods This was a prospective, nonrandomized observational study of 100 consecutive patients who underwent elective on‐pump isolated or combined valve surgery and CABG. Coronary stenoses were assessed using conventional and quantitative coronary angiography assessment. The flow and pulsatility index (PI) of the grafts were assessed by transit‐time flowmetry during cardioplegic arrest and at the end of the operation. Fractional polynomials were used to explore linearity, followed by multivariable regression analysis. Results Univariate analysis demonstrated higher flows at the end of the operation in patients who had higher flows with the cross‐clamp on (P

Computed tomography angiography (CTA) collateral scoring can identify patients most likely to benefit from mechanical thrombectomy and those more likely to have good outcomes and ranges from 0 (no collaterals) to 3 (complete collaterals). In this study, we used a machine learning approach to categorise the degree of collateral flow in 98 patients who were eligible for mechanical thrombectomy and generate an e-CTA collateral score (CTA-CS) for each patient (e-STROKE SUITE, Brainomix Ltd., Oxford, UK). Three experienced neuroradiologists (NRs) independently estimated the CTA-CS, first without and then with knowledge of the e-CTA output, before finally agreeing on a consensus score. Addition of the e-CTA improved the intraclass correlation coefficient (ICC) between NRs from 0.58 (0.46–0.67) to 0.77 (0.66–0.85, p = 0.003). Automated e-CTA, without NR input, agreed with the consensus score in 90% of scans with the remaining 10% within 1 point of the consensus (ICC 0.93, 0.90–0.95). Sensitivity and specificity for identifying favourable collateral flow (collateral score 2–3) were 0.99 (0.93–1.00) and 0.94 (0.70–1.00), respectively. e-CTA correlated with the Alberta Stroke Programme Early CT Score (Spearman correlation 0.46, p < 0.001) highlighting the value of good collateral flow in maintaining tissue viability prior to reperfusion. In conclusion, ­e-CTA provides a real-time and fully automated approach to collateral scoring with the potential to improve consistency of image interpretation and to independently quantify collateral scores even without expert rater input.

Introduction and Objectives Primary Spontaneous Pneumothorax (PSP) is a common condition with a high recurrence rate (28–33%).1, 2, 3 Current guidelines suggest referral for recurrence prevention surgery after the second episode. Identifying patients at greater risk of recurrence would allow a more stratified approach. A number of factors have been proposed previously, but none have been robustly proven. This study used a large prospectively collected dataset from the RAMPP (Randomised Ambulatory Management of Primary Pneumothorax) Trial1 in the UK to assess risk factors for pneumothorax recurrence up to 12 months. Methods The RAMPP dataset included 423 patients: 236 were managed actively (either ambulatory or standard care arms) and an observational cohort of 187 patients with small, minimally symptomatic pneumothoraces managed conservatively. A Cox proportional hazards model was used to assess risk of recurrence by the following variables: patient age, sex, size of initial pneumothorax, smoking history (tobacco and marijuana), personal history of prior pneumothorax history, family history and treatments given. Results The overall recurrence rate at 12 months was 20.6% (87/423) with a significantly lower rate in the conservatively-managed observational cohort (22/187, 11.8%), than the ambulatory and standard care arms (28/117, 23.9%, and 37/119, 31.1%, respectively) (p Conclusion Patients with small, minimally symptomatic pneumothorax have a low recurrence rate (11.8%). Previous history of pneumothorax is associated with increased risk of recurrence. Further work is required to identify other risk factors to determine who may benefit from early recurrence prevention procedures. References Hallifax RJ. Lancet 2020;396:39–49. Hallifax RJ. JAMA 2018;320(14):1471–1480. Bobbio A. Thorax 2015;70:653–58.

Background Pleural infection (PI) is a common and complicated disease. Empirical antibiotic usage has been correlated to poor clinical outcomes. Although the identification of the pathogen is essential for successful treatment, conventional culture-based pathogen detection techniques fail in approximately 40% of cases. Therefore, the bacteriology of PI remains incomplete. Next generation sequencing (NGS) is a molecular-based methodology which could be applied to metagenomics studies and improve pathogen recognition. Aim To investigate and characterise the bacterial patterns of PI. Methods Pleural fluid specimens from the ‘Pleural Infection Longitudinal Outcome Study’1 (PILOT, n=243) were subjected to bacterial DNA extraction followed by 16S rRNA NGS. The DADA2 and Phyloseq R packages were used for the analysis of the data. Results We identified 363 distinct species of bacteria, with various abundances among the samples. Diverse patterns between monomicrobial and polymicrobial PI were detected. 131 (54%) samples had one pathogen with abundance over 50% and 89 (36%) samples had at least three pathogens with relative abundance over 10%, suggesting a polymicrobial infection. Discussion We developed a methodology to extract bacterial DNA from pleural fluid specimens derived from patients with PI and the quality was satisfactory to be used for NGS. 16S rRNA gene NGS has the potential to detect the total microbiome of pleural fluid samples1 from complex PI. Funding National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). Reference Corcoran, J.P., et al. Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study. Eur Respir J ( 2020).

Objectives The Arterial Revascularization Trial (ART) was designed to compare 10-year survival in bilateral versus single internal thoracic artery grafts. The intention-to-treat analysis has showed comparable outcomes between the 2 groups but an explanatory analysis suggested that those receiving 2 or more arterial grafts had better survival. Whether the exclusive use of arterial grafts provide further benefit is unclear. Methods We performed an exploratory analysis of the ART based on conduits actually received (as-treated principle). From ART cohort, only patients receiving at least 3 grafts were included. The final population consisted of 1084, 1010, and 390 patients in the single arterial graft (SAG) group, in the multiple arterial graft (MAG) group (2 or more arterial grafts with additional saphenous veins) and total arterial graft (TAG) group (3 or more arterial grafts only) respectively. Inverse probability of treatment weighting was used for comparison. Results When compared with the SAG group, there was a significant trend toward a reduction of 10-year mortality in the MAG and TAG group (test for trend P = .02). The TAG group was associated with the lowest risk of late mortality (hazard ratio, 0.68; 95% confidence interval, 0.48-0.96; P = .03) and with a significant risk reduction of the composite of death/myocardial infarction/stroke and repeat revascularization (hazard ratio, 0.71; 95% confidence interval, 0.53-0.94; P = .02). Conclusions When compared with SAG, both MAG and TAG represent valuable strategies to improve clinical outcomes following coronary artery bypass grafting but TAG can potentially provide further benefit.

Background Most patients with malignant pleural mesothelioma (MPM) seek treatment with malignant pleural effusion (MPE). In vitro evidence suggests that MPE may not be a simple bystander of malignancy, but rather potentially has biological properties that improve cancer cell survival and promote cancer progression. If this is the case, MPE management may need to shift from current symptomatic strategies to aggressive fluid removal to impact survival. Research Question Is there an association between pleural fluid exposure and survival in MPM? Study Design and Methods Data from 761 patients who received a diagnosis of MPM between 2008 and 2018 were collected from patient medical records in three UK pleural units. Data included factors previously identified as influencing prognosis in MPM. Medical imaging was reviewed for presence, size, and duration of pleural effusion. Time-dependent covariate analysis of pleural fluid exposure and survival (model included weight loss, serum albumin, hemoglobin, MPM subtype, performance status, chemotherapy, and age) and multivariate Cox regression analysis of pleurodesis and survival were conducted. Results Median overall survival was 278 days (interquartile range, 127-505 days; 95% CI, 253-301 days). Pleural fluid exposure duration showed no association with survival (hazard ratio, 1.0; 95% CI, 1.0-1.0). Median survival was 473, 378, and 258 days with complete, partial, and no pleurodesis (P = .008). Interpretation Pleurodesis success seems to be associated with improved survival; however, it is unclear whether duration of MPM exposure to pleural fluid is associated with survival within the limitations of this retrospective study. Future prospective studies are required to assess this potentially important mechanism.

Background Coronary artery bypass graft (CABG) surgery is an effective way to manage advanced coronary heart disease. Diabetes is associated with higher risk of mortality in patients undergoing CABG but the effects of obesity, and the interactions between diabetes and obesity in the context of CABG, have not been fully explored. Methods The Arterial Revascularisation Trial (ART) compared ten-year mortality in patients undergoing CABG randomised to single or bilateral internal thoracic arterial grafts. Effects of diabetes and obesity on mortality and risk (sternal wound complications) were explored. Diabetes was defined according to clinical history at baseline and combined insulin and non-insulin dependent patients, and obesity was defined as body mass index (BMI) ≥30kg/m2 at baseline. Results Information on diabetes, obesity and ten-year mortality were documented for 3094 patients who were included in the analysis. Mean age was 64 years, 86% male, mean weight 82kg and BMI 28. Diabetes was documented in 24% and obesity in 30% and as expected obese patients were more likely to be diabetic. The hazard ratios (95% confidence intervals) for ten-year mortality using the no diabetes, non-obese group as a reference were 1.33 (1.08, 1.64) (diabetes, non-obese), 0.93 (0.75, 1.16) (no diabetes, obese) and 1.18 (0.91, 1.54) (diabetes, obese) groups (Figure 1). Similar patterns of risk were observed whether patients were randomised to receive single or bilateral internal thoracic arteries and diabetes appeared to be the main driver of elevated risk of early sternal wound complications following CABG. Conclusions Obesity and diabetes are closely associated but our analysis shows that patterns of risk of death after CABG are not additive for these characteristics, and obesity may actually be associated with lower death rates in patients with and without diabetes. These findings will be explored further to understand mechanisms and interactions with other factors. Figure 1. Hazard ratios at 10 years Funding Acknowledgement Type of funding source: None

Background Patients with diabetes and/or obesity are at higher risk of adverse outcomes following coronary artery bypass grafting (CABG). The use of bilateral internal thoracic arteries (BITA) can potentially offer survival benefit in higher risk patients compared to single internal thoracic artery (SITA) in patients undergoing CABG, but the overall evidence base for BITA has not influenced guidelines, and there are concerns over increased risk of sternal wound complications. Methods We conducted a systematic review of the literature to identify observational studies and randomised controlled trials (RCT) comparing the efficacy (mortality) and safety (sternal wound infection) of BITA and SITA in diabetic and obese patients. Results We identified 18 observational studies and one RCT to obtain data comparing BITA and SITA in 19,589 diabetic patients, and two observational studies and one RCT comparing BITA and SITA in 6972 obese patients. Pooled analysis demonstrated significant mortality benefit of BITA compared to SITA in diabetic patients (risk ratio [RR] 0.79; 95% confidence interval [CI] 0.70, 0.90; Z=3.62, p=0.0003; I2=88%) (Figure 1a). Pooled analysis in obese patients found no significant difference in mortality rates between BITA and SITA (RR 0.73, 95% CI 0.47, 1.12; Z=1.43, p=0.15; I2=78%) (Figure 1b). A significantly higher rate of sternal wound complications following BITA was observed in diabetic (RR 1.53, 95% CI 1.23, 1.90; Z=3.86, p=0.0001; I2=4%) and obese patients (RR 2.24, 95% CI 1.63, 3.07; Z=5.00, p Conclusions BITA is associated with better long-term survival in diabetic patients, but most of the supportive data comes from observational studies. The effects of BITA grafting in patients who are obese is uncertain due to low numbers. BITA is associated with higher rates of sternal wound complications than SITA in both diabetic and obese patients. Further research is needed to understand if BITA has a role in higher risk patients undergoing CABG. Figure 1. Pooled all-cause mortality Funding Acknowledgement Type of funding source: None

Background: Postoperative atrial fibrillation (pAF) after coronary artery bypass grafting is a common complication. Whether pAF is associated with an increased risk of cerebrovascular accident (CVA) remains uncertain. We investigated the association between pAF and long-term risk of CVA by performing a post hoc analysis of 10-year outcomes of the ART (Arterial Revascularization Trial). Methods: For the present analysis, among patients enrolled in the ART (n=3102), we excluded those who did not undergo surgery (n=25), had a history of atrial fibrillation (n=45), or had no information on the incidence of pAF (n=9). The final population consisted of 3023 patients, of whom 734 (24.3%) developed pAF with the remaining 2289 maintaining sinus rhythm. Competing risk and Cox regression analyses were used to investigate the association between pAF and the risk of CVA. Results: At 10 years, the cumulative incidence of CVA was 6.3% (4.6%–8.1%) versus 3.7% (2.9%–4.5%) in patients with pAF and sinus rhythm, respectively. pAF was an independent predictor of CVA at 10 years (hazard ratio, 1.53 [95% CI, 1.06–2.23]; P =0.025) even when CVAs that occurred during the index admission were excluded from the analysis (hazard ratio, 1.47 [95% 1.02–2.11]; P =0.04). Conclusions: Patients with pAF after coronary artery bypass grafting are at higher risk of CVA. These findings challenge the notion that pAF is a benign complication.

Objective: Malignant Pleural Mesothelioma (MPM) has a poor prognosis and high symptom burden. RESPECT-Meso was a multicenter randomized study examining the role of early specialist palliative care (SPC) on quality of life (QoL) with MPM. This is a post-hoc exploratory analysis of the symptom burden and unmet needs identified from RESPECT-Meso participants. Methods: Exploratory analysis from 174 participants using the General Health Status (GHS) measure (from the EORTC QLQ-C30 QoL questionnaire) and 87 participants using validated assessment questionnaires in those randomized to SPC. Eligibility for the study included confirmed MPM with diagnosis Results: Participants were predominantly male (79.9%), mean age 72.8 years, PS was 0 in 38%, 78% of MPM was epithelioid. At least 3 symptoms were reported in 69.8% of participants, including fatigue (81%), dyspnea (73.3%), pain (61.2%), weight loss (59.3%). Anxiety was reported by 54.7% of participants, 52.3% low mood and 48.8% anhedonia symptoms. After multivariable adjustment, only pain remained statistically significant with a hazard ratio (HR) 2.9 (95% CI 1.3-6.7; p = 0.01). For each 1 unit increase in GHS score, the HR for death was 0.987 (0.978-0.996; p = 0.006), indicating a worse reported QoL is related to shorter survival. Unmet needs were common: 25.9% wanted more information about their condition, 24.7% about their care and 21.2% about their treatment. 79.1% were concerned about the effect of their illness on family. Conclusion: There is a high symptom burden in mesothelioma despite good baseline performance status. A worse QoL is associated with a worse survival. Unmet needs are common, perhaps highlighting a need for improved communication and information sharing.

Background Diabetes is associated with higher risk of mortality in patients undergoing coronary artery bypass graft (CABG) but the effects of obesity, and the interactions between diabetes and obesity in the context of CABG, have not been fully explored. Methods The Arterial Revascularisation Trial (ART) randomised patients to single- or bilateral internal thoracic arterial graft plus other vein or arterial grafts as needed and followed them for 10 years to compare mortality, clinical outcomes and safety. In this analysis we explored the effects of diabetes and obesity on mortality and risk (sternal wound complications) . Diabetes was defined according to clinical history at baseline and combined insulin and non-insulin dependent patients, and obesity was defined as body mass index (BMI) ≥30kg/m2 at baseline. Results Data on diabetes, obesity and ten-year mortality were available for 3094 patients who were included in the analysis. Mean age was 64 years, 86% male, mean weight 82kg and BMI 28. Diabetes was documented in 24% and obesity in 30% and as expected obese patients were more likely to be diabetic. The hazard ratios (95% confidence intervals) for ten-year mortality using the no-diabetes, non-obese group as a reference were 1.33 (1.08, 1.64) (diabetes, non-obese), 0.93 (0.75, 1.16) (no diabetes, obese) and 1.18 (0.91, 1.54) (diabetes, obese) groups (Figure). Similar patterns of risk were observed whether patients were randomised to receive single or bilateral internal thoracic arteries and diabetes appeared to be the main driver of elevated risk of early sternal wound complications following CABG. Conclusions Obesity and diabetes often occur in the same patients, but our analysis shows that patterns of risk of death after CABG are not additive for these characteristics, and obesity may actually be associated with lower death rates in patients with and without diabetes. Sternal wound complications appeared to be driven more by diabetes than obesity. Further analyses will be presented to explore the possible mechanisms for these observations. Conflict of Interest None

Background Obesity and diabetes put patients are at higher risk of mortality and other adverse outcomes following coronary artery bypass grafting (CABG) and are becoming more common. The use of bilateral internal thoracic arteries (BITA) can potentially offer survival benefit in higher risk patients compared to single internal thoracic artery (SITA) in patients undergoing CABG. Current evidence does not support the routine use of BITA and this approach is associated with a higher risk of sternal wound complications. Methods We conducted a systematic review of the literature to identify observational studies and randomised controlled trials (RCT) comparing efficacy (mortality) and safety (sternal wound infection) of BITA and SITA in diabetic and obese patients. Results Eighteen observational studies and one RCT (subgroup analysis) were identified comparing BITA and SITA in 19,589 patients with diabetes. In contrast there were just two observational studies and one RCT (subgroup analysis) comparing BITA and SITA in 6972 obese patients. Pooled analysis demonstrated significant mortality benefit of BITA compared to SITA in diabetic patients (risk ratio [RR] 0.79; 95% confidence interval [CI] 0.70, 0.90; Z=3.62, p=0.0003; I2=88%) (Figure 1b). Pooled analysis in obese patients found no significant difference in mortality rates between BITA and SITA (RR 0.73, 95% CI 0.47, 1.12; Z=1.43, p=0.15; I2=78%), although the overall effect was for a beneficial trend for BITA (Figure 1a). A significantly higher rate of sternal wound complications following BITA was observed in diabetic (RR 1.53, 95% CI 1.23, 1.90; Z=3.86, p=0.0001; I2=4%) and obese patients (RR 2.24, 95% CI 1.63, 3.07; Z=5.00, p Conclusions In a pooled analysis, BITA is associated with better long-term survival in diabetic patients, but most of the supportive data comes from observational studies. The effects of BITA grafting in patients who are obese is uncertain due to low numbers of patients available for analysis. BITA is associated with higher rates of sternal wound complications than SITA in both diabetic and obese patients. Further studies are needed to understand the benefits and risks of multiple arterial grafting in patients with diabetes and/or obesity. Conflict of Interest None

Thoracic electrical bioimpedance (TEB) and transthoracic echocardiography (TTE) are non-invasive methods to estimate stroke volume (SV) and cardiac output (CO). Thoracic electrical bioimpedance is not in widespread clinical use with reports of inaccurate cardiac output estimation compared to invasive monitors, particularly in non-healthy populations. We explore its use as a trend monitor by comparing it against thoracic echocardiography in fifteen healthy volunteers undergoing two physical challenges designed to vary cardiac output. Of all paired values, 54.6% showed gross trend agreement and only 1.9% showed direct disagreement between the two monitors. Our results show thoracic bioimpedance may have a role as a non-invasive cardiac output trend monitor in healthy volunteer studies.

Background Primary spontaneous pneumothorax occurs in otherwise healthy young patients. Optimal management is not defined and often results in prolonged hospitalisation. Data on efficacy of ambulatory options are poor. We aimed to describe the duration of hospitalisation and safety of ambulatory management compared with standard care. Methods In this open-label, randomised controlled trial, adults (aged 16–55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years. Patients were randomly assigned (1:1) to treatment with either an ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both). The primary outcome was total length of hospital stay including re-admission up to 30 days after randomisation. Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis. The trial was prospectively registered with the International Standard Randomised Clinical Trials Number, ISRCTN79151659. Findings Of 776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119). At day 30, the median hospitalisation was significantly shorter in the 114 patients with available data who received ambulatory treatment (0 days [IQR 0–3]) than in the 113 with available data who received standard care (4 days [IQR 0–8]; p Interpretation Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events. This data suggests that primary spontaneous pneumothorax can be managed for outpatients, using ambulatory devices in those who require intervention. Funding UK National Institute for Health Research.

Background: RCTs (randomized controlled trials) are the preferred source of evidence to support professional societies’ guidelines. The fragility index (FI), defined as the minimum number of patients whose status would need to switch from nonevent to event to render a statistically significant result nonsignificant, quantitatively estimates the robustness of RCT results. We evaluate RCTs supporting current guidelines on myocardial revascularization using the FI and FI minus number of patients lost to follow-up. Methods and Results: The FI and FI minus number of patients lost to follow-up of RCTs supporting the 2012 American College of Cardiology/American Heart Association Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease, the 2014 Focused Update of the American College of Cardiology/American Heart Association Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease, and the 2018 European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines for Myocardial Revascularization were calculated. Of 414 RCTs identified, 160 were eligible for FI calculation. The median FI was 8.0 (95% CI, 5.0–9.0) and the median FI minus number of patients lost to follow-up was 1.0 (95% CI, 0.0–3.0). FI was ≤3, indicating very limited robustness, in 44 (27.5%) RCTs, and was lower than the number LTF, indicating limited robustness, in 68 (42.5%) RCTs. FI was significantly (all P P -value level. Conclusions: More than a quarter of RCTs that support current guidelines on myocardial revascularization have a FI of 3 or lower, and over 40% of trials reveal a FI that is lower than the number of patients lost to follow-up. These findings suggest that the robustness of the findings that support current myocardial revascularization guidelines is tenuous and vulnerable to change as new evidence from RCTs appears.

Summary Background The prevalence of malignant pleural effusion is increasing worldwide, but prognostic biomarkers to plan treatment and to understand the underlying mechanisms of disease progression remain unidentified. The PROMISE study was designed with the objectives to discover, validate, and prospectively assess biomarkers of survival and pleurodesis response in malignant pleural effusion and build a score that predicts survival. Methods In this multicohort study, we used five separate and independent datasets from randomised controlled trials to investigate potential biomarkers of survival and pleurodesis. Mass spectrometry-based discovery was used to investigate pleural fluid samples for differential protein expression in patients from the discovery group with different survival and pleurodesis outcomes. Clinical, radiological, and biological variables were entered into least absolute shrinkage and selection operator regression to build a model that predicts 3-month mortality. We evaluated the model using internal and external validation. Findings 17 biomarker candidates of survival and seven of pleurodesis were identified in the discovery dataset. Three independent datasets (n=502) were used for biomarker validation. All pleurodesis biomarkers failed, and gelsolin, macrophage migration inhibitory factor, versican, and tissue inhibitor of metalloproteinases 1 (TIMP1) emerged as accurate predictors of survival. Eight variables (haemoglobin, C-reactive protein, white blood cell count, Eastern Cooperative Oncology Group performance status, cancer type, pleural fluid TIMP1 concentrations, and previous chemotherapy or radiotherapy) were validated and used to develop a survival score. Internal validation with bootstrap resampling and external validation with 162 patients from two independent datasets showed good discrimination (C statistic values of 0·78 [95% CI 0·72–0·83] for internal validation and 0·89 [0·84–0·93] for external validation of the clinical PROMISE score). Interpretation To our knowledge, the PROMISE score is the first prospectively validated prognostic model for malignant pleural effusion that combines biological and clinical parameters to accurately estimate 3-month mortality. It is a robust, clinically relevant prognostic score that can be applied immediately, provide important information on patient prognosis, and guide the selection of appropriate management strategies. Funding European Respiratory Society, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants.

BackgroundChest drain displacement is a common clinical problem that occurs in 9–42% of cases and results in treatment failure or additional pleural procedures conferring unnecessary risk. A novel chest drain with an integrated intrapleural balloon may reduce the risk of displacement.MethodsA prospective randomised controlled trial comparing the balloon drain to standard care (12 F chest drain with no balloon) with the primary outcome of objectively defined unintentional or accidental chest drain displacement.Results267 patients were randomised (primary outcome data available in 257, 96.2%). Displacement occurred less frequently using the balloon drain (displacement 5 of 128, 3.9%; standard care displacement 13 of 129, 10.1%) but this was not statistically significant (OR for drain displacement 0.36, 95% CI 0.13–1.0, Chi-squared 1 degree of freedom (df)=2.87, p=0.09). Adjusted analysis to account for minimisation factors and use of drain sutures demonstrated balloon drains were independently associated with reduced drain fall-out rate (adjusted OR 0.27, 95% CI 0.08–0.87, p=0.028). Adverse events were higher in the balloon arm than the standard care arm (balloon drain 59 of 131, 45.0%; standard care 18 of 132, 13.6%; Chi-squared 1 df=31.3, pConclusionBalloon drains reduce displacement compared with standard drains independent of the use of sutures but are associated with increased adverse events specifically during drain removal. The potential benefits of the novel drain should be weighed against the risks, but may be considered in practices where sutures are not routinely used.

IntroductionMonitoring vital signs in hospital is an important part of safe patient care. However, there are no robust estimates of the workload it generates for nursing staff. This makes it difficult to plan adequate staffing to ensure current monitoring protocols can be delivered.ObjectiveTo estimate the time taken to measure and record one set of patient’s vital signs observations; and to identify factors associated with time to measure and record one set of patient’s vital signs observations.MethodsWe undertook a time-and-motion study of 16 acute medical or surgical wards across four hospitals in England. One hospital recorded vital signs on paper, while three recorded measurements on electronic devices. Two trained observers followed a standard operating procedure to record the time taken to measure and record vital sign observations. We used mixed-effects models to estimate the mean time using whole observation rounds, which included preparation time, or time spent taking observations at the bedside. We tested whether our estimates were influenced by nurse, ward and hospital factors.ResultsAfter excluding non-vital signs related interruptions, dividing the length of an observation round by the number of observations in that round yielded an estimated time per observation set of 5 minutes and 1 second (95% Confidence Interval (CI) = 4:39-5:24). If interruptions within the round were included, the estimated time was 6:26 (95% CI = 6:01-6:50). If only time taking each patient’s observations at the bedside was considered, after excluding non-vital signs related interruptions the estimated time was 3:45 (95% CI = 3:32-3:58). We found no substantial differences by hospital, ward or nurse characteristics, despite different systems for recording observations being used across the hospitals.DiscussionThe time taken to observe and record a patient’s vital signs is considerable, so changes to recommended observation frequency could have major workload implications. Variation in estimates derived from previous studies may, in part, arise from a lack of clarity about what was included in the reported times. We found no evidence that nurses save time when using electronic vital signs recording, or that the grade of staff taking the observation influenced the time taken.ConclusionsTaking and recording vital signs observations is time consuming and the impact of interruptions and preparation away from the bedside is considerable. When considering the nursing workload around vital signs observations, no assumption of relative efficiency should be made if different technologies or staff groups are deployed.

Background: Respiratory complications are common after cardiac surgery and the use of extracorporeal circulation is one of the main causes of lung injury. We hypothesized a better postoperative respiratory function in off-pump coronary artery bypass grafting (OPCABG) as compared with “on-pump coronary artery bypass grafting” (ONCABG). Methods: This is a retrospective, single-center study at a cardiothoracic intensive care unit (ICU) in a tertiary university hospital. Consecutive data on 339 patients undergoing elective CABG (n = 215 ONCABG, n = 124 OPCABG) were collected for 1 year from the ICU electronic medical records. We compared respiratory variables (Pao2, Pao2/Fio2 ratio, Sao2, and Paco2) at 7 predefined time points (ICU admission, postoperative hours 1, 3, 6, 12, 18, and 24). We also evaluated time to extubation, rates of reintubation, and use of noninvasive ventilation (NIV). We used mixed-effects linear regression models (with time as random effect for clustering of repeated measures) adjusted for a predetermined set of covariates. Results: The values of Pao2 and Pao2/Fio2 were significantly higher in the OPCABG group only at ICU admission (mean differences: 9.7 mm Hg, 95% confidence interval [CI] 3.1-16.2; and 27, 95% CI 6.1-47.7, respectively). The OPCABG group showed higher Paco2, overall ( P = .02) and at ICU admission (mean difference 1.8 mm Hg, 95% CI: 0.6-3), although mean values were always within normal range in both groups. No differences were seen in Sao2 values, time to extubation, rate of reintubation rate, and use of postoperative NIV. Extubation rate was higher in OPCABG only at postoperative hour 12 (92% vs ONCABG 82%, P = .02). Conclusion: The OPCABG showed only marginal improvements of unlikely clinical meaning in oxygenation as compared to ONCABG in elective low-risk patients.

BackgroundThe use of bilateral internal thoracic (mammary) arteries for coronary-artery bypass grafting (CABG) may improve long-term outcomes as compared with the use of a single internal-thoracic-artery plus vein grafts.MethodsWe randomly assigned patients scheduled for CABG to undergo single or bilateral internal-thoracic-artery grafting in 28 cardiac surgical centers in seven countries. The primary outcome was death from any cause at 10 years. The composite of death from any cause, myocardial infarction, or stroke was a secondary outcome. Interim analyses were prespecified at 5 years of follow-up.ResultsA total of 3102 patients were enrolled; 1554 were randomly assigned to undergo single internal-thoracic-artery grafting (the single-graft group) and 1548 to undergo bilateral internal-thoracic-artery grafting (the bilateral-graft group). At 5 years of follow-up, the rate of death was 8.7% in the bilateral-graft group and 8.4% in the single-graft group (hazard ratio, 1.04; 95% confidence interval [CI], 0.81 to 1.32; P=0.77), and the rate of the composite of death from any cause, myocardial infarction, or stroke was 12.2% and 12.7%, respectively (hazard ratio, 0.96; 95% CI, 0.79 to 1.17; P=0.69). The rate of sternal wound complication was 3.5% in the bilateral-graft group versus 1.9% in the single-graft group (P=0.005), and the rate of sternal reconstruction was 1.9% versus 0.6% (P=0.002).ConclusionsAmong patients undergoing CABG, there was no significant difference between those receiving single internal-thoracic-artery grafts and those receiving bilateral internal-thoracic-artery grafts with regard to mortality or the rates of cardiovascular events at 5 years of follow-up. There were more sternal wound complications with bilateral internal-thoracic-artery grafting than with single internal-thoracic-artery grafting. Ten-year follow-up is ongoing. (Funded by the British Heart Foundation and others; ART Current Controlled Trials number, ISRCTN46552265.)

Background and purpose We investigated whether automated and reader-based ASPECTS in acute stroke patients are affected by different CT image reconstruction algorithms. Methods ASPECTS were assessed by commercial software and four independent blinded readers (two residents and two consultants) from different CT reconstructions (filtered back projection and two different iterative reconstruction [IR] levels) in 43 acute stroke patients with proximal middle cerebral artery occlusion. Ground truth was provided by an expert with unrestricted data access. Results The residents showed significant variations between IR levels and had a significantly lower internal consistency across different reconstructions compared to the software, which performed similarly to the consultants. The consultant as well as the software also showed different deviations from ground truth with different IR levels, which were least at IR strength level 2. Conclusions CT image postprocessing affects either automated or human ASPECTS in acute stroke patients. This effect was most pronounced in the less experienced readers, while the software had the most robust performance.

Background Pleural infection (PI) is a common and complicated disease, bearing a heavy healthcare burden worldwide. Definitive pathogen identification based on current methods occurs in only 40% of cases, mainly due to prior antibiotic administration and special bacterial nutritional culture requirements. To this end PI microbiology knowledge remains incomplete. Novel deep sequencing techniques could increase the rate of reliable pathogen identification and shed light on the complex polymicrobial patterns of PI. Aim To investigate and further characterise the microbial nature of PI using next generation sequencing (NGS). Methods Pleural fluid samples from the ‘Pleural Infection Longitudinal Outcome Study’ (PILOT, ISRCTN50236700, n=243) underwent bacterial DNA extraction followed by 16S rRNA NGS using Illumina MiSeq. Data were analysed with DADA2 and Phyloseq R packages. Results Bacterial DNA from pleural fluid samples was successfully extracted and sequenced. NGS detected 391 diverse pathogens up to the genus level and analysis showed that PI is a polymicrobial disease. 131 (54%) samples had one pathogen with relative abundance over 50% and 89 (36%) samples had at least 3 pathogens with relative abundance over 10%. Streptococcus Pneumoniae was detected in 40 (16%) and Staphylococcus Aureus in 20 (8%) samples. Discussion It is feasible to extract and sequence bacterial DNA from pleural fluid samples from patients with PI. 16S rRNA NGS is a robust method for investigating the total bacteriology of pleural fluid samples. Funding National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC).

Background Current reference ranges for blood pressure and heart rate throughout pregnancy have a poor evidence base. Methods This is a systematic review and meta-analysis. We included studies measuring blood pressure or heart rate from healthy pregnant women within defined gestational periods of 16 weeks or less. We analysed systolic blood pressure, diastolic blood pressure and heart rate by gestational age. We assessed effects of measurement year and method. Results We included 39 studies undertaken in 1967–2017, containing 124,349 systolic measurements from 36,239 women, 124,291 diastolic measurements from 36,181 women and 10,948 heart rate measurements from 8317 women. Mean (95% CI) systolic blood pressure was lowest at 10 weeks gestation, 110.4 (108.5, 112.3) mmHg, rising to 116.0 (113.6, 118.4) mmHg at 40 weeks, mean (95% CI) change 5.6 (4.0, 7.2) mmHg. Mean (95% CI) diastolic blood pressure was lowest at 21 weeks gestation, 65.9 (64.2, 67.7) mmHg; rising to 72.8 (71.0, 74.6) mmHg at 40 weeks, mean (95% CI) change 6.9 (6.2, 7.5) mmHg. Mean (95% CI) heart rate rose from 79.3 (75.5, 83.1) beats/min at 10 weeks to 86.9 (82.2, 91.6) beats/min at 40 weeks gestation, mean (95% CI) change 7.6 (1.8, 13.4) beats/min. Studies using manual measurement reported higher diastolic blood pressures than studies using automated measurement, mean (95 CI) difference 4.9 (0.8, 8.9) mmHg. Diastolic blood pressure increased by 0.26 (95% CI 0.10–0.43) mmHg/year. Including only higher-quality studies had little effect on findings, with heterogeneity remaining high (I2 statistic > 50%). Conclusions Significant gestational blood pressure and heart rate changes occur that should be taken into account when assessing pregnant women. Commonly taught substantial decreases in blood pressure mid-pregnancy were not seen and heart rate increases were lower than previously thought. Manual and automated blood pressure measurement cannot be used interchangeably. Increases in diastolic blood pressure over the last half-century and differences between published studies show contemporary data are required to define current normal ranges. Study registration PROSPERO CRD42014009673

Objective: Over the last 15 years, developments in camera technology have coincided with increased availability and affordability. This has led to an increasing interest in using these technologies in healthcare settings. Image-based monitoring methods potentially allow multiple vital signs to be measured concurrently using a non-contact sensor. We have undertaken a systematic review of the current availability and performance of these monitoring methods. Approach: A multiple database search was conducted using MEDLINE, Embase, CINAHL, Cochrane Library, OpenGrey, IEEE Xplore Library and ACM Digital Library to July 2018. We included studies comparing image-based heart rate, respiratory rate, oxygen saturation and blood pressure monitoring methods against one or more validated reference device(s). Each included study was assessed using the modified GRRAS criteria for reporting bias. Main results: Of 30 279 identified studies, 161 were included in the final analysis. Twenty studies (20/161, 12%) were carried out on patients in clinical settings, while the remainder were conducted in academic settings using healthy volunteer populations. The 18–40 age group was best represented across the identified studies. One hundred and twenty studies (120/161, 75%) estimated heart rate, followed by 62 studies (62/161, 39%) estimating respiratory rate. Fewer studies focused on oxygen saturation (11/161, 7%) or blood pressure (6/161, 4%) estimation. Fifty-one heart rate studies (51/120, 43%) and 24 respiratory rate studies (24/62, 39%) used Bland–Altman analysis to report their results. Of the heart rate studies, 28 studies (28/51, 55%) showed agreement within industry standards of 5 beats per minute. Only two studies achieved this within clinical settings. Of the respiratory rate studies, 13 studies (13/24, 54%) showed agreement within industry standards of 3 breaths per minute, but only one study achieved this in a clinical setting. Statistical analysis was heterogeneous across studies with frequent inappropriate use of correlation. The majority of studies (99/161, 61%) monitored subjects for under 5 min. Three studies (3/161, 2%) monitored subjects for over 60 min, all of which were conducted in hospital settings. Significance: Heart rate and respiratory rate monitoring using video images is currently possible and performs within clinically acceptable limits under experimental conditions. Camera-derived estimates were less accurate in the proportion of studies conducted in clinical settings. We would encourage thorough reporting of the population studied, details of clinically relevant aspects of methodology, and the use of appropriate statistical methods in future studies. Systematic review registration: PROSPERO CRD42016029167 Protocol: https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-017-0615-3

Background: Malignant pleural effusion (MPE) is a common condition that indicates advanced malignancy as it signals incurability, shortened life expectancy, and severely compromised quality of life. While MPE incidence is increasing worldwide, the discovery of prognostic biomarkers remains an unmet clinical need. Objective: To address that clinical call we designed a study to discover, validate and prospectively assess prognostic and therapeutic biomarkers for MPE and develop score that combines pleural fluid biology with clinical and radiological data. Methods: Five separate and independent patient cohorts (TIME-1, TIME-2, TIME-3, SIMPLE and Pleural Biobank), from previous clinical trials, have been used in order to establish a prognostic and therapeutic score for MPE. We considered clinical, radiological and biological factors as candidate variables. We assessed performance using both internal and external validation. Results: A high throughput mass spectrometry was applied to screen samples of the TIME-2 database for differential protein expression between the groups with differences in survival and pleurodesis outcome. Three databases (TIME1,2,3) were used for the validation of the protein expression. Data from 435 patients was used to develop the PROMISE score, which includes eight variables. Internal validation using bootstrap resampling and external validation using 161 patients (SIMPLE and biobank) both suggested good discrimination (c-index 0.78 and 0.89 respectively). In addition, external validation shows the model is well calibrated. Conclusions: We managed to develop and prospectively validate a prognostic score for MPE patients to estimate risk of 3-month mortality.

Thoracic electrical bioimpedance (TEB) and transthoracic echocardiography (TTE) are non-invasive methods to estimate stroke volume (SV) and cardiac output (CO). Thoracic electrical bioimpedance is not in widespread clinical use with reports of inaccurate cardiac output estimation compared to invasive monitors, particularly in non-healthy populations. We explore its use as a trend monitor by comparing it against thoracic echocardiography in fifteen healthy volunteers undergoing two physical challenges designed to vary cardiac output. Of all paired values, 54.6% showed gross trend agreement and only 1.9% showed direct disagreement between the two monitors. Our results show thoracic bioimpedance may have a role as a non-invasive cardiac output trend monitor in healthy volunteer studies.

IntroductionAmbulatory monitoring systems (AMS) can facilitate early detection of clinical deterioration, and have the potential to improve hospitalised patient outcomes. The objective of this systematic review is to assess the impact of vital signs monitoring on detection of deterioration and related outcomes in hospitalised patients using AMS, in comparison with standard care.Methods and analysisA systematic search was conducted on 27 August 2020 in MEDLINE, Embase, CINAHL, Cochrane Database of Systematic Reviews, CENTRAL and Health Technology Assessment databases, as well as grey literature. Search results will be reviewed in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis checklist for systematic reviews. Studies comparing the use of ambulatory monitoring devices against standard care for deterioration detection and related clinical outcomes in hospitalised patients will be included and further clinical and other outcomes will also be explored. Deterioration-related outcomes may include (but not limited to) unplanned intensive care admissions, rapid response team activation and unscheduled emergency interventions, as defined by the included studies. Two reviewers will independently extract study data and assess the quality and risk of bias of included studies. Where possible, a meta-analysis will be conducted and quantitative results presented. Alternatively, a narrative synthesis will be reported.Ethics and disseminationEthical approval is not required for this study as no primary data will be collected. This study is part of our virtual High Dependency Unit project and will be disseminated through peer-reviewed publications, public and scientific conference presentations.PROSPERO registration numberCRD42020188633.

BackgroundOver 30% of adult patients with pleural infection either die and/or require surgery. There is no robust means of predicting at baseline presentation which patients will suffer a poor clinical outcome. A validated risk prediction score would allow early identification of high-risk patients, potentially directing more aggressive treatment thereafter.ObjectivesTo prospectively assess a previously described risk score (the RAPID (Renal (urea), Age, fluid Purulence, Infection source, Dietary (albumin)) score) in adults with pleural infection.MethodsProspective observational cohort study that recruited patients undergoing treatment for pleural infection. RAPID score and risk category were calculated at baseline presentation. The primary outcome was mortality at 3 months; secondary outcomes were mortality at 12 months, length of hospital stay, need for thoracic surgery, failure of medical treatment and lung function at 3 months.ResultsMortality data were available in 542 out of 546 patients recruited (99.3%). Overall mortality was 10% at 3 months (54 out of 542) and 19% at 12 months (102 out of 542). The RAPID risk category predicted mortality at 3 months. Low-risk mortality (RAPID score 0–2): five out of 222 (2.3%, 95% CI 0.9 to 5.7%); medium-risk mortality (RAPID score 3–4): 21 out of 228 (9.2%, 95% CI 6.0 to 13.7%); and high-risk mortality (RAPID score 5–7): 27 out of 92 (29.3%, 95% CI 21.0 to 39.2%). C-statistics for the scores at 3 months and 12 months were 0.78 (95% CI 0.71–0.83) and 0.77 (95% CI 0.72–0.82), respectively.ConclusionsThe RAPID score stratifies adults with pleural infection according to increasing risk of mortality and should inform future research directed at improving outcomes in this patient population.

Background: Pleural infection is common and associated with significant morbidity and mortality. Previous retrospective data have suggested the sonographic presence of pleural fluid septation at diagnosis may be a prognostic indicator [1]. Method The Pleural Infection Longitudinal Outcome Study (PILOT) was a multinational prospective observational cohort study (n = 551 patients) powered to validate a previously described clinical risk score (RAPID) [2]. The primary outcome was 3-month mortality from pleural infection. Secondary outcomes included surgical referral; failure of initial medical therapy; and length of hospital stay. Data collected included the sonographic extent of pleural fluid septation at diagnosis, as determined by the responsible clinician sonographer. The study was funded by the UK Medical Research Council, and registered with ClinicalTrials.gov (ISRCTN 50236700). Results: The presence of pleural fluid septation did not have a significant impact on the study’s primary outcome (figure 1); although it did reduce the performance of the clinical risk score. Conclusion: Pleural fluid septation does not have an independent impact on mortality from pleural infection, although it may have an influence on other relevant clinical outcomes. References 1. Ultrasound Med Biol 2009; 35(9):1468-74 2. Chest 2014; 145(4):848-55

PurposeMalignant pleural mesothelioma (MPM) has a high symptom burden and poor survival. Evidence from other cancer types suggests some benefit in health-related quality of life (HRQoL) with early specialist palliative care (SPC) integrated with oncological services, but the certainty of evidence is low.MethodsWe performed a multicentre, randomised, parallel group controlled trial comparing early referral to SPC versus standard care across 19 hospital sites in the UK and one large site in Western Australia. Participants had newly diagnosed MPM; main carers were additionally recruited. Intervention: review by SPC within 3 weeks of allocation and every 4 weeks throughout the study. HRQoL was assessed at baseline and every 4 weeks with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30. Primary outcome: change in EORTC C30 Global Health Status 12 weeks after randomisation.ResultsBetween April 2014 and October 2016, 174 participants were randomised. There was no significant between group difference in HRQoL score at 12 weeks (mean difference 1.8 (95% CI −4.9 to 8.5; p=0.59)). HRQoL did not differ at 24 weeks (mean difference −2.0 (95% CI −8.6 to 4.6; p=0.54)). There was no difference in depression/anxiety scores at 12 weeks or 24 weeks. In carers, there was no difference in HRQoL or mood at 12 weeks or 24 weeks, although there was a consistent preference for care, favouring the intervention arm.ConclusionThere is no role for routine referral to SPC soon after diagnosis of MPM for patients who are cared for in centres with good access to SPC when required.Trial registration numberISRCTN18955704.