Re-Visioning Quality Assurance in Higher Education.

A central organising theme of this study is that the regulatory landscape of HE is transforming in ways that are reconstituting Higher Education [HE]. The purpose of this study is to contribute to understandings of the dynamic interaction between regulation and HE. This study focused on Quality Assurance [QA] as a key policy concern and regulatory mechanism of HE at national, European and global levels (L. Harvey, 2005). Drawing on poststructuralist and critical theories I located QA as a mechanism of governing HE and neoliberalism as a key rationality of governing HE. Following Brenner & Theodore (2002), I distinguished between neoliberalism as an abstract idea of the extension of market based values into political, social and personal life and neoliberalisation as the context-dependent process by which neoliberalism takes hold. My data was derived from two key European QA texts: European Standards and Guidelines for Quality Assurance in the European Higher Education Area (ENQA, 2009) and European Association of Psychotherapy Training Accreditation Committee (EAP, 2012a). Using Critical Discourse Analysis as overall methodological framework, these texts were analysed in terms of their institutional, intertextual, discursive and textual contexts through two dialectically related categories: QA as a mechanism of transformation and HE as emerging form – the ‘imaginary’ of the QA project. I examined emerging means by which QA operates, locations in which it occurs, rationalities that underpin it and consequences of its application. My findings identified regulatory transformations involving emerging mechanisms of steerage of HE, such as ‘soft’ and ‘hard’ regulation working together. They identified emerging conceptualisations of quality in HE as an objective, measurable entity and an accountability task, and an emerging ideal of HE that dismantles boundaries between HE and the socio-economic sphere. They identified neoliberalism as one rationality underpinning these transformations and also alternative rationalities, strategies and technologies that affect the trajectory of QA and the formation of HE. Alternatives included challenges to neoliberal ideals, alternative knowledges about QA and HE, and alternative practices of QA. My findings identified pathways of neoliberalisation in HE as neither uniform nor consistent and trajectories of QA and HE as contingent on historic conditions and activities of policy actors. My contribution to the study of HE is to provide new understandings of regulatory landscapes of HE, of how neoliberalism has taken shape in HE spaces utilising regulatory mechanisms and how policy actors insert different alternative meanings in order to contest neoliberal trajectories of HE

Re-Visioning Quality Assurance in Higher Education.

A central organising theme of this study is that the regulatory landscape of HE is transforming in ways that are reconstituting Higher Education [HE]. The purpose of this study is to contribute to understandings of the dynamic interaction between regulation and HE. This study focused on Quality Assurance [QA] as a key policy concern and regulatory mechanism of HE at national, European and global levels (L. Harvey, 2005). Drawing on poststructuralist and critical theories I located QA as a mechanism of governing HE and neoliberalism as a key rationality of governing HE. Following Brenner & Theodore (2002), I distinguished between neoliberalism as an abstract idea of the extension of market based values into political, social and personal life and neoliberalisation as the context-dependent process by which neoliberalism takes hold. My data was derived from two key European QA texts: European Standards and Guidelines for Quality Assurance in the European Higher Education Area (ENQA, 2009) and European Association of Psychotherapy Training Accreditation Committee (EAP, 2012a). Using Critical Discourse Analysis as overall methodological framework, these texts were analysed in terms of their institutional, intertextual, discursive and textual contexts through two dialectically related categories: QA as a mechanism of transformation and HE as emerging form – the ‘imaginary’ of the QA project. I examined emerging means by which QA operates, locations in which it occurs, rationalities that underpin it and consequences of its application. My findings identified regulatory transformations involving emerging mechanisms of steerage of HE, such as ‘soft’ and ‘hard’ regulation working together. They identified emerging conceptualisations of quality in HE as an objective, measurable entity and an accountability task, and an emerging ideal of HE that dismantles boundaries between HE and the socio-economic sphere. They identified neoliberalism as one rationality underpinning these transformations and also alternative rationalities, strategies and technologies that affect the trajectory of QA and the formation of HE. Alternatives included challenges to neoliberal ideals, alternative knowledges about QA and HE, and alternative practices of QA. My findings identified pathways of neoliberalisation in HE as neither uniform nor consistent and trajectories of QA and HE as contingent on historic conditions and activities of policy actors. My contribution to the study of HE is to provide new understandings of regulatory landscapes of HE, of how neoliberalism has taken shape in HE spaces utilising regulatory mechanisms and how policy actors insert different alternative meanings in order to contest neoliberal trajectories of HE

Clinical and economic systematic literature review to support the development of an integrated care programme for chronic disease prevention and management for the Irish health system

Report prepared for the Clinical Strategy and Programmes Division (CSPD) of the Health Service Executive to support the work of integrated clinical care programmes.Based on a clinical and economic systematic review of the international literature, this report presents the evidence on integrated care programmes and generic models of care designed for chronic disease prevention and management. This evidence will support the work of integrated clinical care programmes in Ireland through the Clinical Strategy and Programmes Division of the HSE

Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial

Background Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

Background: Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. Methods: The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). Findings: Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29–146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0– 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25–1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39–1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65–1·60]; p=0·92). Interpretation: These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

Background: Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. Methods: The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). Findings: Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29–146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0– 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25–1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39–1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65–1·60]; p=0·92). Interpretation: These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

BACKGROUND: Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. METHODS: The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). FINDINGS: Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29-146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0- 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25-1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39-1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65-1·60]; p=0·92). INTERPRETATION: These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention. FUNDING: British Heart Foundation

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Re-Visioning Quality Assurance in Higher Education.

A central organising theme of this study is that the regulatory landscape of HE is transforming in ways that are reconstituting Higher Education [HE]. The purpose of this study is to contribute to understandings of the dynamic interaction between regulation and HE. This study focused on Quality Assurance [QA] as a key policy concern and regulatory mechanism of HE at national, European and global levels (L. Harvey, 2005). Drawing on poststructuralist and critical theories I located QA as a mechanism of governing HE and neoliberalism as a key rationality of governing HE. Following Brenner & Theodore (2002), I distinguished between neoliberalism as an abstract idea of the extension of market based values into political, social and personal life and neoliberalisation as the context-dependent process by which neoliberalism takes hold. My data was derived from two key European QA texts: European Standards and Guidelines for Quality Assurance in the European Higher Education Area (ENQA, 2009) and European Association of Psychotherapy Training Accreditation Committee (EAP, 2012a). Using Critical Discourse Analysis as overall methodological framework, these texts were analysed in terms of their institutional, intertextual, discursive and textual contexts through two dialectically related categories: QA as a mechanism of transformation and HE as emerging form – the ‘imaginary’ of the QA project. I examined emerging means by which QA operates, locations in which it occurs, rationalities that underpin it and consequences of its application. My findings identified regulatory transformations involving emerging mechanisms of steerage of HE, such as ‘soft’ and ‘hard’ regulation working together. They identified emerging conceptualisations of quality in HE as an objective, measurable entity and an accountability task, and an emerging ideal of HE that dismantles boundaries between HE and the socio-economic sphere. They identified neoliberalism as one rationality underpinning these transformations and also alternative rationalities, strategies and technologies that affect the trajectory of QA and the formation of HE. Alternatives included challenges to neoliberal ideals, alternative knowledges about QA and HE, and alternative practices of QA. My findings identified pathways of neoliberalisation in HE as neither uniform nor consistent and trajectories of QA and HE as contingent on historic conditions and activities of policy actors. My contribution to the study of HE is to provide new understandings of regulatory landscapes of HE, of how neoliberalism has taken shape in HE spaces utilising regulatory mechanisms and how policy actors insert different alternative meanings in order to contest neoliberal trajectories of HE

Re-Visioning Quality Assurance in Higher Education.

A central organising theme of this study is that the regulatory landscape of HE is transforming in ways that are reconstituting Higher Education [HE]. The purpose of this study is to contribute to understandings of the dynamic interaction between regulation and HE. This study focused on Quality Assurance [QA] as a key policy concern and regulatory mechanism of HE at national, European and global levels (L. Harvey, 2005). Drawing on poststructuralist and critical theories I located QA as a mechanism of governing HE and neoliberalism as a key rationality of governing HE. Following Brenner & Theodore (2002), I distinguished between neoliberalism as an abstract idea of the extension of market based values into political, social and personal life and neoliberalisation as the context-dependent process by which neoliberalism takes hold. My data was derived from two key European QA texts: European Standards and Guidelines for Quality Assurance in the European Higher Education Area (ENQA, 2009) and European Association of Psychotherapy Training Accreditation Committee (EAP, 2012a). Using Critical Discourse Analysis as overall methodological framework, these texts were analysed in terms of their institutional, intertextual, discursive and textual contexts through two dialectically related categories: QA as a mechanism of transformation and HE as emerging form – the ‘imaginary’ of the QA project. I examined emerging means by which QA operates, locations in which it occurs, rationalities that underpin it and consequences of its application. My findings identified regulatory transformations involving emerging mechanisms of steerage of HE, such as ‘soft’ and ‘hard’ regulation working together. They identified emerging conceptualisations of quality in HE as an objective, measurable entity and an accountability task, and an emerging ideal of HE that dismantles boundaries between HE and the socio-economic sphere. They identified neoliberalism as one rationality underpinning these transformations and also alternative rationalities, strategies and technologies that affect the trajectory of QA and the formation of HE. Alternatives included challenges to neoliberal ideals, alternative knowledges about QA and HE, and alternative practices of QA. My findings identified pathways of neoliberalisation in HE as neither uniform nor consistent and trajectories of QA and HE as contingent on historic conditions and activities of policy actors. My contribution to the study of HE is to provide new understandings of regulatory landscapes of HE, of how neoliberalism has taken shape in HE spaces utilising regulatory mechanisms and how policy actors insert different alternative meanings in order to contest neoliberal trajectories of HE