27 results on '"Gale, Chris"'
Search Results
2. Childhood outcomes after low‐grade intraventricular haemorrhage: A systematic review and meta‐analysis.
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Rees, Philippa, Callan, Caitriona, Chadda, Karan R., Diviney, James, Harnden, Fergus, Gardiner, Julian, Battersby, Cheryl, Gale, Chris, and Sutcliffe, Alastair
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INTRAVENTRICULAR hemorrhage ,CEREBRAL palsy ,HEARING disorders ,VISION disorders ,GREY literature - Abstract
Aim: To undertake a systematic review and meta‐analysis exploring school‐age neurodevelopmental outcomes of children after low‐grade intraventricular haemorrhage (IVH). Method: The published and grey literature was extensively searched to identify observational comparative studies exploring neurodevelopmental outcomes after IVH grades 1 and 2. Our primary outcome was neurodevelopmental impairment after 5 years of age, which included cognitive, motor, speech and language, behavioural, hearing, or visual impairments. Results: This review included 12 studies and over 2036 infants born preterm with low grade IVH. Studies used 30 different neurodevelopmental tools to determine outcomes. There was conflicting evidence of the composite risk of neurodevelopmental impairment after low‐grade IVH. There was evidence of an association between low‐grade IVH and lower IQ at school age (−4.23, 95% confidence interval [CI] –7.53, −0.92, I2 = 0%) but impact on school performance was unclear. Studies reported an increased crude risk of cerebral palsy after low‐grade IVH (odds ratio [OR] 2.92, 95% CI 1.95, 4.37, I2 = 41%). No increased risk of speech and language impairment or behavioural impairment was found. Few studies addressed hearing and visual impairment. Interpretation: This systematic review presents evidence that low‐grade IVH is associated with specific neurodevelopmental impairments at school age, lending support to the theory that low‐grade IVH is not a benign condition. What this paper adds: The functional impact of low‐grade intraventricular haemorrhage (IVH) at school age is unknown.Low‐grade IVH is associated with a lower IQ at school age.The risk of cerebral palsy is increased after low‐grade IVH.Low‐grade IVH is not associated with speech and language impairment. What this paper adds: The functional impact of low‐grade intraventricular haemorrhage (IVH) at school age is unknown.Low‐grade IVH is associated with a lower IQ at school age.The risk of cerebral palsy is increased after low‐grade IVH.Low‐grade IVH is not associated with speech and language impairment. [ABSTRACT FROM AUTHOR]
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- 2024
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3. Prediction models for heart failure in the community: A systematic review and meta‐analysis.
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Nadarajah, Ramesh, Younsi, Tanina, Romer, Elizabeth, Raveendra, Keerthenan, Nakao, Yoko M., Nakao, Kazuhiro, Shuweidhi, Farag, Hogg, David C., Arbel, Ronen, Zahger, Doron, Iakobishvili, Zaza, Fonarow, Gregg C., Petrie, Mark C., Wu, Jianhua, and Gale, Chris P.
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PREDICTION models ,HEART failure ,DISEASE risk factors ,WHITE women ,WHITE men - Abstract
Aims: Multivariable prediction models can be used to estimate risk of incident heart failure (HF) in the general population. A systematic review and meta‐analysis was performed to determine the performance of models. Methods and results: From inception to 3 November 2022 MEDLINE and EMBASE databases were searched for studies of multivariable models derived, validated and/or augmented for HF prediction in community‐based cohorts. Discrimination measures for models with c‐statistic data from ≥3 cohorts were pooled by Bayesian meta‐analysis, with heterogeneity assessed through a 95% prediction interval (PI). Risk of bias was assessed using PROBAST. We included 36 studies with 59 prediction models. In meta‐analysis, the Atherosclerosis Risk in Communities (ARIC) risk score (summary c‐statistic 0.802, 95% confidence interval [CI] 0.707–0.883), GRaph‐based Attention Model (GRAM; 0.791, 95% CI 0.677–0.885), Pooled Cohort equations to Prevent Heart Failure (PCP‐HF) white men model (0.820, 95% CI 0.792–0.843), PCP‐HF white women model (0.852, 95% CI 0.804–0.895), and REverse Time AttentIoN model (RETAIN; 0.839, 95% CI 0.748–0.916) had a statistically significant 95% PI and excellent discrimination performance. The ARIC risk score and PCP‐HF models had significant summary discrimination among cohorts with a uniform prediction window. 77% of model results were at high risk of bias, certainty of evidence was low, and no model had a clinical impact study. Conclusions: Prediction models for estimating risk of incident HF in the community demonstrate excellent discrimination performance. Their usefulness remains uncertain due to high risk of bias, low certainty of evidence, and absence of clinical effectiveness research. [ABSTRACT FROM AUTHOR]
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- 2023
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4. European Society of Cardiology quality indicators for the care and outcomes of adults with pulmonary arterial hypertension. Developed in collaboration with the Heart Failure Association of the European Society of Cardiology.
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Aktaa, Suleman, Gale, Chris P., Brida, Margarita, Giannakoulas, George, Kovacs, Gabor, Adir, Yochai, Benza, Raymond L., Böhm, Michael, Coats, Andrew, D'Alto, Michele, Escribano‐Subias, Pilar, Ferrari, Pisana, Galiè, Nazzareno, Gibbs, J. Simon R., Gin‐Sing, Wendy, Hoeper, Marius M., Humbert, Marc, Lang, Irene M., Maron, Bradley A., and Meszaros, Gergely
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PULMONARY arterial hypertension , *HEART failure , *CARDIOLOGY , *PULMONARY hypertension , *DELPHI method , *ADULTS - Abstract
Aims: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults with pulmonary arterial hypertension (PAH). Methods and results: We followed the European Society of Cardiology (ESC) methodology for the development of QIs. This included (i) the identification of key domains of care for the management of PAH, (ii) the proposal of candidate QIs following systematic review of the literature, and (iii) the selection of a set of QIs using a modified Delphi method. The process was undertaken in parallel with the writing of the 2022 ESC/European Respiratory Society (ERS) guidelines for the diagnosis and treatment of pulmonary hypertension and involved the Task Force chairs, experts in PAH, Heart Failure Association (HFA) members and patient representatives. We identified five domains of care for patients with PAH: structural framework, diagnosis and risk stratification, initial treatment, follow‐up, and outcomes. In total, 23 main and one secondary QIs for PAH were selected. Conclusion: This document presents the ESC QIs for PAH, describes their development process and offers scientific rationale for their selection. The indicators may be used to quantify and improve adherence to guideline‐recommended clinical practice and improve patient outcomes. [ABSTRACT FROM AUTHOR]
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- 2023
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5. Comparison of care and outcomes for myocardial infarction by heart failure status between United Kingdom and Japan.
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Nakao, Kazuhiro, Dafaalla, Mohamed, Nakao, Yoko M., Wu, Jianhua, Nadarajah, Ramesh, Rashid, Muhammad, Mohammad, Haris, Sumita, Yoko, Nakai, Michikazu, Iwanaga, Yoshitaka, Miyamoto, Yoshihiro, Noguchi, Teruo, Yasuda, Satoshi, Ogawa, Hisao, Mamas, Mamas A., and Gale, Chris P.
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MYOCARDIAL infarction ,ST elevation myocardial infarction ,HEART failure ,CARDIOGENIC shock ,CONGESTIVE heart failure - Abstract
Aims: Prognosis for ST‐segment elevation myocardial infarction (STEMI) is worse when heart failure is present on admission. Understanding clinical practice in different health systems can identify areas for quality improvement initiatives to improve outcomes. In the absence of international comparison studies, we aimed to compare treatments and in‐hospital outcomes of patients admitted with ST elevation myocardial infarction (STEMI) by heart failure status in two healthcare‐wide cohorts. Methods and results: We used two nationwide databases to capture admissions with STEMI in the United Kingdom (Myocardial ischemia National Audit Project, MINAP) and Japan (Japanese Registry of All Cardiac and Vascular Diseases‐Diagnostic Procedure Combination, JROAD‐DPC) between 2012 and 2017. Participants were stratified using the HF Killip classification into three groups; Killip 1: no congestive heart failure, Killip 2–3: congestive heart failure, Killip 4: cardiogenic shock. We calculated crude rate and case mix standardized risk ratios (CSRR) for use of treatments and in‐hospital death. Patients were younger in the United Kingdom (65.4 [13.6] vs. 69.1 [13.0] years) and more likely to have co‐morbidities in the United Kingdom except for diabetes and hypertension. Japan had a higher percentage of heart failure and cardiogenic shock patients among STEMI during admission than that in the United Kingdom. Primary percutaneous coronary intervention (pPCI) rates were lower in the United Kingdom compared with Japan, especially for patients presenting with Killip 2–3 class heart failure (pPCI use in patients with Killip 1, 2–3, 4: Japan, 86.2%, 81.7%, 78.7%; United Kingdom, 79.6%, 58.2% and 79.9%). In contrast, beta‐blocker use was consistently lower in Japan than in the United Kingdom (61.4% vs. 90.2%) across Killip classifications and length of hospital stay longer (17.0 [9.7] vs. 5.0 [7.4] days). The crude rate of in‐hospital mortality increased with increasing Killip class group. Both the crude rate and CSRR was higher in the United Kingdom compared with Japan for Killip 2–3 (15.8% vs. 6.4%, CSRR 1.80 95% CI 1.73–1.87, P < 0.001), and similar for Killip 4 (36.9% vs. 36.3%, CSRR 1.11 95% CI 1.08–1.13, P < 0.001). Conclusions: Important differences in the care and outcomes for STEMI with heart failure exist between the United Kingdom and Japan. Specifically, in the United Kingdom, there was a lower rate of pPCI, and in Japan, fewer patients were prescribed beta blockers and hospital length of stay was longer. This international comparison can inform targeted quality improvement programmes to narrow the outcome gap between health systems. [ABSTRACT FROM AUTHOR]
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- 2023
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6. Association between heart failure quality of care and mortality: a population‐based cohort study using nationwide registries.
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Batra, Gorav, Aktaa, Suleman, Benson, Lina, Dahlström, Ulf, Hage, Camilla, Savarese, Gianluigi, Vasko, Peter, Gale, Chris P., and Lund, Lars H.
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COHORT analysis ,HEART failure ,QUALITY of life ,MORTALITY ,ODDS ratio ,VENTRICULAR ejection fraction - Abstract
Aims: To evaluate the quality of heart failure (HF) care using the European Society of Cardiology (ESC) quality indicators (QIs) for HF and to assess whether better quality of care is associated with improved outcomes. Methods and results: We performed a nationwide cohort study using the Swedish HF registry, consisting of patients with any type of HF at their first outpatient visit or hospitalization. Independent participant data for quality of HF care was evaluated against the ESC QIs for HF, and association with mortality estimated using multivariable Cox regression. In total, 43 704 patients from 80 hospitals across Sweden enrolled between 2013–2019 were included, with median follow‐up 23.6 months. Of the 16 QIs for HF, 13 could be measured and 5 were inversely associated with all‐cause mortality during follow‐up. Higher attainment (≥50% vs. <50% attainment) of the composite opportunity‐based score (combination of QIs into a single score) for patients with reduced ejection fraction was associated with lower all‐cause mortality (adjusted hazard ratio 0.81; 95% confidence interval 0.72–0.91). Attainment of the composite score was less in the outpatient than inpatient setting (adjusted odds ratio 0.85; 95% confidence interval 0.72–0.99). Quality of care varied across hospitals, with assessment of health‐related quality of life being the indicator with the widest variation in attainment (interquartile range 61.7%). Conclusion: Quality of HF care may be measured using the ESC HF QIs. In Sweden, attainment of HF care evaluated using the QIs demonstrated between and within hospital variation, and many QIs were inversely associated with mortality. [ABSTRACT FROM AUTHOR]
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- 2022
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7. Experiences of patients with heart failure with medicines at transition intervention: Findings from the process evaluation of the Improving the Safety and Continuity of Medicines management at Transitions of care (ISCOMAT) programme.
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Powell, Catherine, Ismail, Hanif, Davis, Maureen, Taylor, Andrew, Breen, Liz, Fylan, Beth, Alderson, Sarah L., Gale, Chris P., Kellar, Ian, Silcock, Jonathan, and Alldred, David P.
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PATIENT participation ,SOCIAL support ,TERMINAL care ,TRANSITIONAL care ,MATHEMATICAL models ,RESEARCH methodology ,TIME ,SOCIAL networks ,HOME care services ,MEDICAL personnel ,COMMUNITY health services ,INTERVIEWING ,CONTINUUM of care ,HUMAN services programs ,MEDICATION therapy management ,RANDOMIZED controlled trials ,PHARMACISTS ,CONCEPTUAL structures ,TREATMENT effectiveness ,PSYCHOSOCIAL factors ,COMMUNICATION ,THEORY ,QUALITY assurance ,DESCRIPTIVE statistics ,RESEARCH funding ,STATISTICAL sampling ,CLUSTER analysis (Statistics) ,LOGIC ,HEART failure ,PATIENT safety ,DISCHARGE planning - Abstract
Background: Medicines are often suboptimally managed for heart failure patients across the transition from hospital to home, potentially leading to poor patient outcomes. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme included: understanding the problems faced by patients and healthcare professionals; developing and co‐designing the Medicines at Transitions of care Intervention (MaTI); a cluster randomized controlled trial testing the effectiveness of a complex behavioural MaTI aimed at improving medicines management at the interface between hospitals discharge and community care for patients with heart failure; and a process evaluation. The MaTI included a patient‐held My Medicines Toolkit; enhanced communication between the hospital and the patient's community pharmacist and increased engagement of the community pharmacist postdischarge. This paper reports on the patients' experiences of the MaTI and its implementation from the process evaluation. Design: Twenty one‐to‐one semi‐structured patient interviews from six intervention sites were conducted between November 2018 and January 2020. Data were analysed using the Framework method, involving patients as co‐analysts. Interview data were triangulated with routine trial data, the Consolidated Framework for Implementation Research and a logic model. Results: Within the hospital setting patients engaged with the toolkit according to whether staff raised awareness of the My Medicines Toolkit's importance and the time and place of its introduction. Patients' engagement with community pharmacy depended on their awareness of the community pharmacist's role, support sources and perceptions of involvement in medicines management. The toolkit's impact on patients' medicines management at home included reassurance during gaps in care, increased knowledge of medicines, enhanced ability to monitor health and seek support and supporting sharing medicines management between formal and informal care networks. Conclusion: Many patients perceived that the MaTI offered them support in their medicines management when transitioning from hospital into the community. Importantly, it can be incorporated into and built upon patients' lived experiences of heart failure. Key to its successful implementation is the quality of engagement of healthcare professionals in introducing the intervention. Patient or Public Contribution: Patients were involved in the study design, as qualitative data co‐analysts and as co‐authors. [ABSTRACT FROM AUTHOR]
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- 2022
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8. European Society of Cardiology quality indicators for the care and outcomes of adults with heart failure. Developed by the Working Group for Heart Failure Quality Indicators in collaboration with the Heart Failure Association of the European Society of Cardiology
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Aktaa, Suleman, Polovina, Marija, Rosano, Giuseppe, Abdin, Amr, Anguita, Manuel, Lainscak, Mitja, Lund, Lars H., McDonagh, Theresa, Metra, Marco, Mindham, Richard, Piepoli, Massimo, Störk, Stefan, Tokmakova, Mariya P., Seferović, Petar, Gale, Chris P., and Coats, Andrew J. S.
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HEART failure treatment ,MEDICAL quality control ,KEY performance indicators (Management) ,MEDICAL information storage & retrieval systems ,SYSTEMATIC reviews ,CONCEPTUAL structures ,MEDICAL protocols ,RESPONSIBILITY ,CLINICAL medicine ,INTERPROFESSIONAL relations ,MEDLINE ,DELPHI method ,ADULTS - Abstract
Aims To develop a suite of quality indicators (QIs) for the evaluation of the quality of care for adults with heart failure (HF). Methods and results We followed the ESC methodology for QI development, which involved (i) the identification of the key domains of care for the management of HF by constructing a conceptual framework of HF care, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified Delphi method, and (iv) the evaluation of the feasibility of the developedQIs. TheWorking Group comprised experts in HF management including Task Force members of the 2021 European Society of Cardiology (ESC) Clinical Practice Guidelines for HF, members of the Heart Failure Association (HFA), Quality Indicator Committee and a patient representative. In total, 12 main and 4 secondary QIs were selected across five domains of care for the management of HF: (1) structural framework, (2) patient assessment, (3) initial treatment, (4) therapy optimization, and (5) assessment of patient health-related quality of life. Conclusion We present the ESC HFA QIs for HF, describe their development process and provide the scientific rationale for their selection. The indicators may be used to quantify and improve adherence to guideline-recommended clinical practice and thus improve patient outcomes. [ABSTRACT FROM AUTHOR]
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- 2022
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9. Revascularisation strategies in patients with significant left main coronary disease during the COVID‐19 pandemic.
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Mohamed, Mohamed O., Curzen, Nick, de Belder, Mark, Goodwin, Andrew T., Spratt, James C, Balacumaraswami, Lognathen, Deanfield, John, Martin, Glen P., Rashid, Muhammad, Shoaib, Ahmad, Gale, Chris P, Kinnaird, Tim, and Mamas, Mamas A.
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- 2021
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10. Outcomes of COVID‐19‐positive acute coronary syndrome patients: A multisource electronic healthcare records study from England.
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Rashid, Muhammad, Wu, Jianhua, Timmis, Adam, Curzen, Nick, Clarke, Sarah, Zaman, Azfar, Nolan, James, Shoaib, Ahmad, Mohamed, Mohamed O, Belder, Mark A., Deanfield, John, Gale, Chris P., and Mamas, Mamas A.
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CARDIOGENIC shock ,ACUTE coronary syndrome ,COVID-19 ,ELECTRONIC records ,CARDIOVASCULAR diseases ,MYOCARDIAL infarction ,CORONARY care units ,MORTALITY - Abstract
Background: Patients with underlying cardiovascular disease and coronavirus disease 2019 (COVID‐19) infection are at increased risk of morbidity and mortality. Objectives: This study was designed to characterize the presenting profile and outcomes of patients hospitalized with acute coronary syndrome (ACS) and COVID‐19 infection. Methods: This observational cohort study was conducted using multisource data from all acute NHS hospitals in England. All consecutive patients hospitalized with diagnosis of ACS with or without COVID‐19 infection between 1 March and 31 May 2020 were included. The primary outcome was in‐hospital and 30‐day mortality. Results: A total of 12 958 patients were hospitalized with ACS during the study period, of which 517 (4.0%) were COVID‐19‐positive and were more likely to present with non‐ST‐elevation acute myocardial infarction. The COVID‐19 ACS group were generally older, Black Asian and Minority ethnicity, more comorbid and had unfavourable presenting clinical characteristics such as elevated cardiac troponin, pulmonary oedema, cardiogenic shock and poor left ventricular systolic function compared with the non‐COVID‐19 ACS group. They were less likely to receive an invasive coronary angiography (67.7% vs 81.0%), percutaneous coronary intervention (PCI) (30.2% vs 53.9%) and dual antiplatelet medication (76.3% vs 88.0%). After adjusting for all the baseline differences, patients with COVID‐19 ACS had higher in‐hospital (adjusted odds ratio (aOR): 3.27; 95% confidence interval (CI): 2.41–4.42) and 30‐day mortality (aOR: 6.53; 95% CI: 5.1–8.36) compared to patients with the non‐COVID‐19 ACS. Conclusion: COVID‐19 infection was present in 4% of patients hospitalized with an ACS in England and is associated with lower rates of guideline‐recommended treatment and significant mortality hazard. [ABSTRACT FROM AUTHOR]
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- 2021
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11. The Heart Failure Association Atlas: Heart Failure Epidemiology and Management Statistics 2019.
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Seferović, Petar M., Vardas, Panagiotis, Jankowska, Ewa A., Maggioni, Aldo P., Timmis, Adam, Milinković, Ivan, Polovina, Marija, Gale, Chris P., Lund, Lars H., Lopatin, Yuri, Lainscak, Mitja, Savarese, Gianluigi, Huculeci, Radu, Kazakiewicz, Dzianis, Coats, Andrew J.S., and National Heart Failure Societies of the ESC member countries (see Appendix)
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HEART failure ,LENGTH of stay in hospitals ,EPIDEMIOLOGY ,MIDDLE-income countries ,TOTAL quality management - Abstract
Aims: The Heart Failure Association (HFA) of the European Society of Cardiology (ESC) developed the HFA Atlas to provide a contemporary description of heart failure (HF) epidemiology, resources, reimbursement of guideline-directed medical therapy (GDMT) and activities of the National Heart Failure Societies (NHFS) in ESC member countries.Methods and Results: The HFA Atlas survey was conducted in 2018-2019 in 42 ESC countries. The quality and completeness of source data varied across countries. The median incidence of HF was 3.20 [interquartile range (IQR) 2.66-4.17] cases per 1000 person-years, ranging from ≤2 in Italy and Denmark to >6 in Germany. The median HF prevalence was 17.20 (IQR 14.30-21) cases per 1000 people, ranging from ≤12 in Greece and Spain to >30 in Lithuania and Germany. The median number of HF hospitalizations was 2671 (IQR 1771-4317) per million people annually, ranging from <1000 in Latvia and North Macedonia to >6000 in Romania, Germany and Norway. The median length of hospital stay for an admission with HF was 8.50 (IQR 7.38-10) days. Diagnostic and management resources for HF varied, with high-income ESC member countries having substantially more resources compared with middle-income countries. The median number of hospitals with dedicated HF centres was 1.16 (IQR 0.51-2.97) per million people, ranging from <0.10 in Russian Federation and Ukraine to >7 in Norway and Italy. Nearly all countries reported full or partial reimbursement of standard GDMT, except ivabradine and sacubitril/valsartan. Almost all countries reported having NHFS or working groups and nearly half had HF patient organizations.Conclusions: The first report from the HFA Atlas has shown considerable heterogeneity in HF disease burden, the resources available for its management and data quality across ESC member countries. The findings emphasize the need for a systematic approach to the capture of HF statistics so that inequalities and improvements in care may be quantified and addressed. [ABSTRACT FROM AUTHOR]- Published
- 2021
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12. Institutional use of National Clinical Audits by healthcare providers.
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McVey, Lynn, Alvarado, Natasha, Keen, Justin, Greenhalgh, Joanne, Mamas, Mamas, Gale, Chris, Doherty, Patrick, Feltbower, Richard, Elshehaly, Mai, Dowding, Dawn, and Randell, Rebecca
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AUDITING ,HEALTH services administration ,HOSPITALS ,INTERVIEWING ,RESEARCH methodology ,MEDICAL quality control ,NATIONAL health services ,QUALITY assurance ,QUALITATIVE research ,THEMATIC analysis ,CLINICAL governance - Abstract
Rationale, aims, and objectives: Healthcare systems worldwide devote significant resources towards collecting data to support care quality assurance and improvement. In the United Kingdom, National Clinical Audits are intended to contribute to these objectives by providing public reports of data on healthcare treatment and outcomes, but their potential for quality improvement in particular is not realized fully among healthcare providers. Here, we aim to explore this outcome from the perspective of hospital boards and their quality committees: an under‐studied area, given the emphasis in previous research on the audits' use by clinical teams. Methods: We carried out semi‐structured, qualitative interviews with 54 staff in different clinical and management settings in five English National Health Service hospitals about their use of NCA data, and the circumstances that supported or constrained such use. We used Framework Analysis to identify themes within their responses. Results: We found that members and officers of hospitals' governing bodies perceived an imbalance between the benefits to their institutions from National Clinical Audits and the substantial resources consumed by participating in them. This led some to question the audits' legitimacy, which could limit scope for improvements based on audit data, proposed by clinical teams. Conclusions: Measures to enhance the audits' perceived legitimacy could help address these limitations. These include audit suppliers moving from an emphasis on cumulative, retrospective reports to real‐time reporting, clearly presenting the "headline" outcomes important to institutional bodies and staff. Measures may also include further negotiation between hospitals, suppliers and their commissioners about the nature and volume of data the latter are expected to collect; wider use by hospitals of routine clinical data to populate audit data fields; and further development of interactive digital technologies to help staff explore and report audit data in meaningful ways. [ABSTRACT FROM AUTHOR]
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- 2021
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13. Determining Optimal Outcome Measures in a Trial Investigating No Routine Gastric Residual Volume Measurement in Critically Ill Children.
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Tume, Lyvonne N., Arch, Barbara, Woolfall, Kerry, Roper, Louise, Deja, Elizabeth, Jones, Ashley P., Latten, Lynne, Eccleson, Helen, Hickey, Helen, Pathan, Nazima, Preston, Jenny, Beissel, Anne, Andrzejewska, Izabela, Gale, Chris, Valla, Frederic V., Dorling, Jon, and Paediatric Intensive Care Society Study Group (PICS-SG)
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CRITICALLY ill children ,VOLUME measurements ,PEDIATRIC intensive care ,MEDICAL personnel ,INTENSIVE care units - Abstract
Background: Choosing trial outcome measures is important. When outcomes are not clinically relevant or important to parents/patients, trial evidence is less likely to be implemented into practice. This study aimed to determine optimal outcome measures for a trial of no routine gastric residual volume (GRV) measurement in critically ill children.Methods: A mixed-methods approach was used: a focused literature review, parent and clinician interviews, a modified 2-round Delphi, and a stakeholder consensus meeting.Results: The review generated 13 outcomes. Fourteen pediatric intensive care unit (PICU) parents proposed 3 additional outcomes; these 16 were then rated by 28 clinicians in Delphi round 1. Six further outcomes were proposed, and 22 outcomes were rated in the second round. No items were voted "consensus out." The 18 "no-consensus" items were voted in a face-to-face meeting by 30 participants. The final 12 outcome measures were time to reach energy targets, ventilator-associated pneumonia, vomiting, time enteral feeds withheld per 24 hours, necrotizing enterocolitis, length of invasive ventilation, PICU length of stay, mortality, change in weight and markers of feed intolerance (parenteral nutrition administered), feed formula altered, and change to postpyloric feeds all secondary to feed intolerance.Conclusion: We have identified 12 outcomes for a trial of no GRV measurement through a multistage process, seeking views of parents and clinicians. [ABSTRACT FROM AUTHOR]- Published
- 2021
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14. The cancer patient and cardiology.
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Zamorano, José Luis, Gottfridsson, Christer, Asteggiano, Riccardo, Atar, Dan, Badimon, Lina, Bax, Jeroen J., Cardinale, Daniela, Cardone, Antonella, Feijen, Elizabeth A.M., Ferdinandy, Péter, López‐Fernández, Teresa, Gale, Chris P., Maduro, John H., Moslehi, Javid, Omland, Torbjørn, Plana Gomez, Juan Carlos, Scott, Jessica, Suter, Thomas M., and Minotti, Giorgio
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MEDICAL personnel ,CANCER patients ,CARDIOLOGY ,TREATMENT effectiveness ,CANCER patient care - Abstract
Advances in cancer treatments have improved clinical outcomes, leading to an increasing population of cancer survivors. However, this success is associated with high rates of short‐ and long‐term cardiovascular (CV) toxicities. The number and variety of cancer drugs and CV toxicity types make long‐term care a complex undertaking. This requires a multidisciplinary approach that includes expertise in oncology, cardiology and other related specialties, and has led to the development of the cardio‐oncology subspecialty. This paper aims to provide an overview of the main adverse events, risk assessment and risk mitigation strategies, early diagnosis, medical and complementary strategies for prevention and management, and long‐term follow‐up strategies for patients at risk of cancer therapy‐related cardiotoxicities. Research to better define strategies for early identification, follow‐up and management is highly necessary. Although the academic cardio‐oncology community may be the best vehicle to foster awareness and research in this field, additional stakeholders (industry, government agencies and patient organizations) must be involved to facilitate cross‐discipline interactions and help in the design and funding of cardio‐oncology trials. The overarching goals of cardio‐oncology are to assist clinicians in providing optimal care for patients with cancer and cancer survivors, to provide insight into future areas of research and to search for collaborations with industry, funding bodies and patient advocates. However, many unmet needs remain. This document is the product of brainstorming presentations and active discussions held at the Cardiovascular Round Table workshop organized in January 2020 by the European Society of Cardiology. [ABSTRACT FROM AUTHOR]
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- 2020
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15. Impact of Coronavirus Disease 2019 Pandemic on the Incidence and Management of Out-of-Hospital Cardiac Arrest in Patients Presenting With Acute Myocardial Infarction in England.
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Rashid, Muhammad, Gale, Chris P., Curzen, Nick, Ludman, Peter, De Belder, Mark, Timmis, Adam, Mohamed, Mohamed O., Lüscher, Thomas F., Hains, Julian, Jianhua Wu, Shoaib, Ahmad, Kontopantelis, Evangelos, Roebuck, Chris, Denwood, Tom, Deanfield, John, Mamas, Mamas A., Rashid Hons, Muhammad, Gale Hons, Chris P, Curzen Hons, Nick, and Ludman Hons, Peter
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- 2020
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16. No seasonal influence on cognitive performance in a national sample of older adults in New Zealand.
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Barak, Yoram, Leitch, Sharon, Gale, Chris, and Glue, Paul
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COGNITION disorder risk factors ,MENTAL depression risk factors ,COGNITION in old age ,RISK assessment ,SEASONS ,STATISTICS ,DATA analysis ,KRUSKAL-Wallis Test - Abstract
Objectives: A recent North American study reported seasonal differences in cognitive functioning in older adults. We assessed seasonality of cognitive functioning in a large data set of older adults in New Zealand. Methods: The International Residential Assessment Instrument‐Home Care (interRAI‐HC) data set was analysed using a non‐parametric method for testing seasonal distribution of cognitive and depression scale scores. Results: Participants were 73 285 New Zealanders 65 years and older who completed their first interRAI‐HC assessment (mean age, 81.4 years; 57% female). We analysed this sample cross‐tabulating season (summer, autumn, winter and spring) and the Cognitive Performance Scale (CPS) score (Kruskal‐Wallis test, P = 0.45). Month‐by‐month CPS scores also demonstrated no variation (Spearman's test, P = 0.96). There was no association between season of assessment and the Depression Rating Scale score, ruling out variability in affect impacting on cognitive performance (Kruskal‐Wallis test, P = 0.99). Conclusion: Our findings, limited to the Southern Hemisphere, demonstrate a lack of seasonality in cognitive performance and impairment in older adults. [ABSTRACT FROM AUTHOR]
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- 2020
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17. Adding value to core outcome set development using multimethod systematic reviews.
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Brunton, Ginny, Webbe, James, Oliver, Sandy, and Gale, Chris
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META-analysis ,MULTITRAIT multimethod techniques ,PARTICIPANT observation ,QUALITATIVE research ,DELPHI method ,CASE studies - Abstract
Trials evaluating the same interventions rarely measure or report identical outcomes. This limits the possibility of aggregating effect sizes across studies to generate high‐quality evidence through systematic reviews and meta‐analyses. To address this problem, core outcome sets (COS) establish agreed sets of outcomes to be used in all future trials. When developing COS, potential outcome domains are identified by systematically reviewing the outcomes of trials, and increasingly, through primary qualitative research exploring the experiences of key stakeholders, with relevant outcome domains subsequently determined through transdisciplinary consensus development. However, the primary qualitative component can be time consuming with unclear impact. We aimed to examine the potential added value of a qualitative systematic review alongside a quantitative systematic review of trial outcomes to inform COS development in neonatal care using case analysis methods. We compared the methods and findings of a scoping review of neonatal trial outcomes and a scoping review of qualitative research on parents', patients', and professional caregivers' perspectives of neonatal care. Together, these identified a wider range and greater depth of health and social outcome domains, some unique to each review, which were incorporated into the subsequent Delphi process and informed the final set of core outcome domains. Qualitative scoping reviews of participant perspectives research, used in conjunction with quantitative scoping reviews of trials, could identify more outcome domains for consideration and could provide greater depth of understanding to inform stakeholder group discussion in COS development. This is an innovation in the application of research synthesis methods. [ABSTRACT FROM AUTHOR]
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- 2020
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18. Methodological decisions influence the identification of potential core outcomes in studies related to pre-eclampsia: an analysis informing the development of recommendations for future core outcome set developers.
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Duffy, JMN, Hirsch, M, Ziebland, S, McManus, RJ, Brown, Mark, Gale, Chris, Grobman, William, Fitzpatrick, Ray, Karumanchi, S. Ananth, Lucas, Nuala, Magee, Laura, Mol, Ben, Stark, Michael, Thangaratinam, Shakila, Wilson, Mathew, Hooft, Janneke, Dadelszen, Peter, Williamson, Paula R., Khan, Khalid S., and McManus, R J
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PREECLAMPSIA ,THEMATIC analysis ,META-analysis ,MEDICAL history taking ,QUANTITATIVE research ,PREECLAMPSIA diagnosis ,DECISION making ,HEALTH outcome assessment ,PRENATAL diagnosis ,RESEARCH funding - Abstract
Objective: To quantify the effect of different methodological decisions on the identification of potential core outcomes to inform the development of recommendations for future core coutcome set developers.Design: Mixed methods study.Setting: A core outcome set for pre-eclampsia was used as an exemplar.Sample: A long list of potential core outcomes was developed by undertaking a systematic review of pre-eclampsia trials and performing a thematic analysis of in-depth patient interviews.Methods: Specific methods used to generate long lists of potential core outcomes were evaluated.Results: Different methodological decisions had a substantial impact on the identification of potential core outcomes. Extracting outcomes from published pre-eclampsia trials was an effective way of identifying 48 maternal, eight fetal, 25 neonatal outcomes, and eight patient-reported outcomes. Limiting the extraction of outcomes to primary outcomes or outcomes commonly reported in pre-eclampsia trials reduced the number and diversity of potential core outcomes identified. Thematic analysis of in-depth patient interviews ensured an additional five patient reported outcomes and six outcomes related to future child health were identified.Conclusions: Future core outcome set developers should use quantitative and qualitative methods when developing a long list of potential core outcomes. TWEETABLE ABSTRACT: @OfficialNIHR research published in @BJOGtweets informs new recommendations for future @coreoutcomes developers. [ABSTRACT FROM AUTHOR]- Published
- 2019
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19. Development and Validation of a Novel Risk Score for In-Hospital Major Bleeding in Acute Myocardial Infarction:-The SWEDEHEART Score.
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Simonsson, Moa, Winell, Henric, Olsson, Henrik, Szummer, Karolina, Alfredsson, Joakim, Hall, Marlous, Dondo, Tatendashe B., Gale, Chris P., and Jernberg, Tomas
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- 2019
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20. Temporal changes in treatments and outcomes after acute myocardial infarction among cancer survivors and patients without cancer, 1995 to 2013.
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Gong, Inna Y., Yan, Andrew T., Ko, Dennis T., Earle, Craig C., Cheung, Winson Y., Peacock, Stuart, Hall, Marlous, Gale, Chris P., and Chan, Kelvin K. W.
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HEALTH of cancer patients ,MYOCARDIAL infarction treatment ,CANCER complications ,CANCER patient medical care ,HEALTH outcome assessment ,CARDIOVASCULAR diseases ,CORONARY angiography - Abstract
Background: There is a paucity of information about treatment and mortality trends after acute myocardial infarction (AMI) for cancer survivors (CS).Methods: In this population-based study, the authors compared temporal trends of treatments and outcomes (mortality, nonfatal cardiovascular outcomes), among CS and patients without cancer (the noncancer patient [NCP] group) with AMI in Ontario (Canada) using inverse probability treatment weight (IPTW)-adjusted modeling.Results: Of 270,089 patients with AMI (22,907 CS, 247,182 NCP, 1995-2013; median follow-up, 10.1 and 11.0 years, respectively), the use of invasive coronary strategies and pharmacotherapies increased and mortality declined for CS and NCP (all Ptrend < .001). At 30 days after AMI, there was no difference between CS and NCP in the receipt of coronary angiography (incidence risk ratio [IRR], 0.98; 95% confidence interval [CI], 0.96-1.01; P = .23), percutaneous coronary intervention (IRR, 0.98; 95% CI, 0.94-1.02; P = .29), or bypass (IRR, 0.93; 95% CI, 0.85-1.02; P = .11). At 90 days after AMI, there was no difference in the receipt of β-blockers, clopidogrel, or nitrates; but CS were less often prescribed angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers and statins. CS had higher all-cause mortality at 30 days (adjusted hazard ratio [HR] 1.12; 95% CI, 1.07-1.17; P < .001), at 1 year (1.16; 95% CI, 1.12-1.20; P < .001), and long term (HR, 1.21; 95% CI, 1.17-1.25; P < .001) and had a greater risk of heart failure (HR, 1.08; 95% CI, 1.03-1.14; P = .001), but not myocardial re-infarction (HR, 0.98; 95% CI, 0.95-1.01; P = .22) or stroke (HR, 1.06; 95% CI, 0.97-1.16; P = .18).Conclusions: Among CS and NCP with AMI in Ontario, similar improvements in mortality and receipt of treatments were observed between 1995 and 2013. However, compared with NCP, CS had a higher risk of mortality and heart failure. Cancer 2018;124:1269-78. © 2017 American Cancer Society. [ABSTRACT FROM AUTHOR]- Published
- 2018
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21. A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia.
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Duffy, James M.N., Hirsch, Martin, Gale, Chris, Pealing, Louise, Kawsar, Anusuya, Showell, Marian, Williamson, Paula R., Khan, Khalid S., Ziebland, Sue, McManus, Richard J., ‘t Hooft, Janneke, Brown, Mark, Grobman, William, Fitzpatrick, Ray, Ananth Karumanchi, S., Lucas, Nuala, Magee, Laura, Mol, Ben, Stark, Michael, and Thangaratinam, Shakila
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- 2017
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22. Sex Differences in Treatments, Relative Survival, and Excess Mortality Following Acute Myocardial Infarction: National Cohort Study Using the SWEDEHEART Registry.
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Alabas, Oras A., Gale, Chris P., Hall, Marlous, Rutherford, Mark J., Szummer, Karolina, Lawesson, Sofia Sederholm, Alfredsson, Joakim, Lindahl, Bertil, and Jernberg, Tomas
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- 2017
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23. Relative Survival After Transcatheter Aortic Valve Implantation: How Do Patients Undergoing Transcatheter Aortic Valve Implantation Fare Relative to the General Population?.
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Martin, Glen P., Sperrin, Matthew, Hulme, William, Ludman, Peter F., de Belder, Mark A., Toff, William D., Alabas, Oras, Moat, Neil E., Doshi, Sagar N., Buchan, Iain, Deanfield, John E., Gale, Chris P., and Mamas, Mamas A.
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- 2017
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24. Prognostic burden of heart failure recorded in primary care, acute hospital admissions, or both: a population-based linked electronic health record cohort study in 2.1 million people.
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Koudstaal, Stefan, Pujades-Rodriguez, Mar, Denaxas, Spiros, Gho, Johannes M. I. H., Shah, Anoop D., Ning Yu, Patel, Riyaz S., Gale, Chris P., Hoes, Arno W., Cleland, John G., Asselbergs, Folkert W., and Hemingway, Harry
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ADRENERGIC beta blockers ,AGE distribution ,ACE inhibitors ,CONFIDENCE intervals ,HEART failure ,HOSPITAL care ,HOSPITAL admission & discharge ,LONGITUDINAL method ,MINERALOCORTICOIDS ,PATIENTS ,PRIMARY health care ,SEX distribution ,SURVIVAL ,DEATH certificates ,ELECTRONIC health records ,SECONDARY care (Medicine) ,CHEMICAL inhibitors ,THERAPEUTICS ,PROGNOSIS - Abstract
Aims The prognosis of patients hospitalized for worsening heart failure (HF) is well described, but not that of patients managed solely in non-acute settings such as primary care or secondary outpatient care. We assessed the distribution of HF across levels of healthcare, and assessed the prognostic differences for patients with HF either recorded in primary care (including secondary outpatient care) (PC), hospital admissions alone, or known in both contexts. Methods and results This study was part of the CALIBER programme, which comprises linked data from primary care, hospital admissions, and death certificates for 2.1 million inhabitants of England. We identified 89 554 patients with newly recorded HF, of whom 23 547 (26%) were recorded in PC but never hospitalized, 30 629 (34%) in hospital admissions but not known in PC, 23 681 (27%) in both, and 11 697 (13%) in death certificates only. The highest prescription rates of ACE inhibitors, beta-blockers, and mineralocorticoid receptor antagonists was found in patients known in both contexts. The respective 5-year survival in the first three groups was 43.9% [95% confidence interval (CI) 43.2-44.6%], 21.7% (95% CI 21.1-22.2%), and 39.8% (95% CI 39.2-40.5%), compared with 88.1% (95% CI 87.9-88.3%) in the age- and sex-matched general population. Conclusion In the general population, one in four patients with HF will not be hospitalized for worsening HF within a median follow-up of 1.7 years, yet they still have a poor 5-year prognosis. Patients admitted to hospital with worsening HF but not known with HF in primary care have the worst prognosis and management. Mitigating the prognostic burden of HF requires greater consistency across primary and secondary care in the identification, profiling, and treatment of patients. [ABSTRACT FROM AUTHOR]
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- 2017
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25. Hospital Surgical Volumes and Mortality after Coronary Artery Bypass Grafting: Using International Comparisons to Determine a Safe Threshold.
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Gutacker, Nils, Bloor, Karen, Cookson, Richard, Gale, Chris P., Maynard, Alan, Pagano, Domenico, Pomar, José, Bernal‐Delgado, Enrique, Pomar, José, Bernal-Delgado, Enrique, and as part of the ECHO collaboration
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CORONARY artery bypass ,PUBLIC health ,REGRESSION analysis ,CARDIOVASCULAR disease related mortality ,HOSPITAL care - Abstract
Objective: To estimate a safe minimum hospital volume for hospitals performing coronary artery bypass graft (CABG) surgery.Data Source: Hospital data on all publicly funded CABG in five European countries, 2007-2009 (106,149 patients).Design: Hierarchical logistic regression models to estimate the relationship between hospital volume and mortality, allowing for case mix. Segmented regression analysis to estimate a threshold.Findings: The 30-day in-hospital mortality rate was 3.0 percent overall, 5.2 percent (95 percent CI: 4.0-6.4) in low-volume hospitals, and 2.1 percent (95 percent CI: 1.8-2.3) in high-volume hospitals. There is a significant curvilinear relationship between volume and mortality, flatter above 415 cases per hospital per year.Conclusions: There is a clear relationship between hospital CABG volume and mortality in Europe, implying a "safe" threshold volume of 415 cases per year. [ABSTRACT FROM AUTHOR]- Published
- 2017
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26. Maternal and neonatal outcomes among spontaneous vaginal births occurring in or out of water following intrapartum water immersion: The POOL cohort study.
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Sanders, Julia, Barlow, Christy, Brocklehurst, Peter, Cannings‐John, Rebecca, Channon, Susan, Cutter, Judith, Hunter, Billie, Jokinen, Mervi, Lugg‐Widger, Fiona, Milosevic, Sarah, Gale, Chris, Milton, Rebecca, Morantz, Leah, Paranjothy, Shantini, Plachcinski, Rachel, and Robling, Michael
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Objective Design Setting Sample Methods Main outcome measures Results Conclusion Warm water immersion during labour provides women with analgesia and comfort. This cohort study aimed to establish among women using intrapartum water immersion analgesia, without antenatal or intrapartum risk factors, whether waterbirth is as safe for them and their babies as leaving the water before birth.Cohort study with non‐inferiority design.Twenty‐six UK NHS maternity services.A total of 73 229 women without antenatal or intrapartum risk factors, using intrapartum water immersion, between 1 January 2015 and 30 June 2022. The analysis excluded 12 827 (17.5%) women who received obstetric or anaesthetic interventions before birth.Non‐inferiority analysis of retrospective and prospective data captured in NHS maternity and neonatal information systems.Maternal primary outcome: obstetric anal sphincter injury (OASI) by parity; neonatal composite primary outcome: fetal or neonatal death, neonatal unit admission with respiratory support or administration of antibiotics within 48 hours of birth.Rates of the primary outcomes were no higher among waterbirths compared with births out of water: rates of OASI among nulliparous women (waterbirth: 730/15 176 [4.8%] versus births out of water: 641/12 210 [5.3%]; adjusted odds ratio [aOR] 0.97, one‐sided 95% CI, −∞ to 1.08); rates of OASI among parous women (waterbirth: 269/24 451 [1.1%] versus births out of water 144/8565 [1.7%]; aOR 0.64, one‐sided 95% CI −∞ to 0.78) and rates of the composite adverse outcome among babies (waterbirth 263/9868 [2.7%] versus births out of water 224/5078 [4.4%]; aOR 0.65, one‐sided 95% CI −∞ to 0.79).Among women using water immersion during labour, remaining in the pool and giving birth in water was not associated with an increase in the incidence of adverse primary maternal or neonatal outcomes. [ABSTRACT FROM AUTHOR]
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- 2024
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27. European Society of Cardiology quality indicators update for the care and outcomes of adults with heart failure. The Heart Failure Association of the ESC.
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Abdin, Amr, Wilkinson, Chris, Aktaa, Suleman, Böhm, Michael, Polovina, Marija, Rosano, Giuseppe, Lainscak, Mitja, Lund, Lars H., McDonagh, Theresa, Metra, Marco, Adamo, Marianna, Mindham, Richard, Piepoli, Massimo, Abdelhamid, Magdy, Störk, Stefan, Tokmakova, Maria P., Seferović, Petar, Coats, Andrew J.S., and Gale, Chris P.
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HEART failure , *HEART failure patients , *CARDIOLOGY , *ADULTS , *QUALITY of life - Abstract
ABSTRACT Aims Methods and results Conclusion To update the European Society of Cardiology (ESC) quality indicators (QIs) for the evaluation of the care and outcomes of adults with heart failure.The Working Group comprised experts in heart failure including members of the ESC Clinical Practice Guidelines Task Force for heart failure, members of the Heart Failure Association, and a patient representative. We followed the ESC methodology for QI development. The 2023 focused guideline update was reviewed to assess the suitability of the recommendations with strongest association with benefit and harm against the ESC criteria for QIs. All the new proposed QIs were individually graded by each panellist via online questionnaires for both validity and feasibility. The existing heart failure QIs also underwent voting to ‘keep’, ‘remove’ or ‘modify’. Five domains of care for the management of heart failure were identified: (1) structural QIs, (2) patient assessment, (3) initial treatment, (4) therapy optimization, and (5) patient health‐related quality of life. In total, 14 ‘main’ and 3 ‘secondary’ QIs were selected across the five domains.This document provides an update of the previously published ESC QIs for heart failure to ensure that these measures are aligned with contemporary evidence. The QIs may be used to quantify adherence to clinical practice as recommended in guidelines to improve the care and outcomes of patients with heart failure. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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