Effectiveness of a Community Program for Older Adults with Type 2 Diabetes and Multimorbidity: A Pragmatic Randomized Controlled Trial

Background Type II diabetes mellitus (T2DM) affects upwards of 25% of Canadian older adults and is associated with high comorbidity and burden. Studies show that lifestyle factors and self-management are associated with improved health outcomes, but many studies lack rigour or exclude older adults, particularly those with multimorbidity. More evidence is needed on the effectiveness of community-based self-management programs in older adults with T2DM and multimorbidity. The study purpose is to evaluate the effect of a community-based intervention versus usual care on physical functioning, mental health, depressive symptoms, anxiety, self-efficacy, self-management, and healthcare costs in older adults with T2DM and 2 or more comorbidities. Methods Community-living older adults with T2DM and two or more chronic conditions were recruited from three Primary Care Networks (PCNs) in Alberta, Canada. Participants were randomly allocated to the intervention or control group in this pragmatic randomized controlled trial comparing the intervention to usual care. The intervention involved up to three in-home visits, a monthly group wellness program, monthly case conferencing, and care coordination. The primary outcome was physical functioning. Secondary outcomes included mental functioning, anxiety, depressive symptoms, self-efficacy, self-management, and the cost of healthcare service use. Intention-to-treat analysis was performed using ANCOVA modeling. Results Of 132 enrolled participants (70-Intervention, 62-Control), 42% were 75 years or older, 55% were female, and over 75% had at least six chronic conditions (in addition to T2DM). No significant group differences were seen for the baseline to six-month change in physical functioning (mean difference: -0.74; 95% CI: − 3.22, 1.74; p-value: 0.56), mental functioning (mean difference: 1.24; 95% CI: − 1.12, 3.60; p-value: 0.30), or other secondary outcomes.. Conclusion No significant group differences were seen for the primary outcome, physical functioning (PCS). Program implementation, baseline differences between study arms and chronic disease management services that are part of usual care may have contributed to the modest study results. Fruitful areas for future research include capturing clinical outcome measures and exploring the impact of varying the type and intensity of key intervention components such as exercise and diet

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

Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial

Background High blood pressure is common in acute stroke and is a predictor of poor outcome; however, large trials of lowering blood pressure have given variable results, and the management of high blood pressure in ultra-acute stroke remains unclear. We investigated whether transdermal glyceryl trinitrate (GTN; also known as nitroglycerin), a nitric oxide donor, might improve outcome when administered very early after stroke onset. Methods We did a multicentre, paramedic-delivered, ambulance-based, prospective, randomised, sham-controlled, blinded-endpoint, phase 3 trial in adults with presumed stroke within 4 h of onset, face-arm-speech-time score of 2 or 3, and systolic blood pressure 120 mm Hg or higher. Participants were randomly assigned (1:1) to receive transdermal GTN (5 mg once daily for 4 days; the GTN group) or a similar sham dressing (the sham group) in UK based ambulances by paramedics, with treatment continued in hospital. Paramedics were unmasked to treatment, whereas participants were masked. The primary outcome was the 7-level modified Rankin Scale (mRS; a measure of functional outcome) at 90 days, assessed by central telephone follow-up with masking to treatment. Analysis was hierarchical, first in participants with a confirmed stroke or transient ischaemic attack (cohort 1), and then in all participants who were randomly assigned (intention to treat, cohort 2) according to the statistical analysis plan. This trial is registered with ISRCTN, number ISRCTN26986053. Findings Between Oct 22, 2015, and May 23, 2018, 516 paramedics from eight UK ambulance services recruited 1149 participants (n=568 in the GTN group, n=581 in the sham group). The median time to randomisation was 71 min (IQR 45–116). 597 (52%) patients had ischaemic stroke, 145 (13%) had intracerebral haemorrhage, 109 (9%) had transient ischaemic attack, and 297 (26%) had a non-stroke mimic at the final diagnosis of the index event. In the GTN group, participants’ systolic blood pressure was lowered by 5·8 mm Hg compared with the sham group (p<0·0001), and diastolic blood pressure was lowered by 2·6 mm Hg (p=0·0026) at hospital admission. We found no difference in mRS between the groups in participants with a final diagnosis of stroke or transient ischaemic stroke (cohort 1): 3 (IQR 2–5; n=420) in the GTN group versus 3 (2–5; n=408) in the sham group, adjusted common odds ratio for poor outcome 1·25 (95% CI 0·97–1·60; p=0·083); we also found no difference in mRS between all patients (cohort 2: 3 [2–5]; n=544, in the GTN group vs 3 [2–5]; n=558, in the sham group; 1·04 [0·84–1·29]; p=0·69). We found no difference in secondary outcomes, death (treatment-related deaths: 36 in the GTN group vs 23 in the sham group [p=0·091]), or serious adverse events (188 in the GTN group vs 170 in the sham group [p=0·16]) between treatment groups. Interpretation Prehospital treatment with transdermal GTN does not seem to improve functional outcome in patients with presumed stroke. It is feasible for UK paramedics to obtain consent and treat patients with stroke in the ultraacute prehospital setting. Funding British Heart Foundation

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

Real Lives Half Lives: Fukushima

Real Lives Half Lives: Fukushima is an exhibition and season exploring cultural and societal responses to disaster, displacement and poisoned lands. What can art do in an ongoing catastrophe? How do citizens respond to a situation that forces tens of thousands of people out of their homes, land, and communities, many of whom probably cannot return for decades? Arts Catalyst presents artworks by artists that respond to the man-made disaster of the 2011 Fukushima Daiichi nuclear meltdown, alongside a series of events exploring the profound social, cultural and political impact of Fukushima in Japan and the lessons we may learn. A Walk in Fukushima - Don’t Follow the Wind The curatorial collective Don't Follow The Wind Chim↑Pom, Kenji Kubota, Eva and Franco Mattes, Jason Waite - who developed the long-term project and its ongoing off-site correspondences, was initiated by Chim↑Pom. On 11 March, 2015, an inaccessible exhibition entitled Don't Follow The Wind opened in Fukushima on the fourth anniversary of the earthquake and tsunami that triggered the ongoing crisis at the Fukushima Dai-ichi Nuclear Power Plant (owned by TEPCO). The exhibition is situated inside the radioactive, evacuated area surrounding the power plant at sites lent by former residents, which include a warehouse, farm, and a recreation centre. The curators collaborated with twelve artists including Ai Weiwei, Chim↑Pom, Grand Guignol Mirai, Nikolaus Hirsch and Jorge Otero-Pailos, Meiro Koizumi, Eva and Franco Mattes, Aiko Miyanaga, Ahmet Öğüt, Trevor Paglen, Taryn Simon, Nobuaki Takekawa, and Kota Takeuchi. Located inside the inaccessible Fukushima exclusion zone, the exhibition is open and yet remains unseen. It will continue to be invisible for years or even decades. At Arts Catalyst, the curatorial collective has formed a correspondence with the inaccessible exhibition. Whilst the artworks in the original exhibition remain unseen in the exclusion zone, other objects from the sites appear on display, bearing material witness to the ongoing catastrophe. These physical artefacts include the farmhouse keys and cafe furniture from a restaurant that had intended to open on the farm a few weeks after the disaster. The restaurant, its inauguration now perpetually deferred, has instead become a host for artworks that the former residents see as conceptual placeholders for their absence. A Walk in Fukushima is an immersive 360-degree video made by the curatorial collective. Filmed in and around the uninhabited radioactive area, the video presents an intimate experience of the inaccessible zone, the venues for the exhibition Don't Follow the Wind, and the power plant itself. The video follows the account of a former resident's visit to his abandoned home inside the exclusion zone; it is shown on headsets made by three generations of a Fukushima family living just outside the zone in a contaminated area deemed 'safe to live' by the government. The accompanying narratives of these headsets share personal accounts and experiences of this new reality: the restrictions, the rumours and the desires for a different future seen from their unstable present. Project Fukushima! - Hikaru Fujii Artist Hikaru Fujii’s film Project Fukushima! follows the preparations for a festival held in Fukushima city five months after the nuclear disaster. The festival, called simply “Fukushima!” was organised by a group of artists and musicians including Yoshihide Otomo. They aim to give visibility to Fukushima’s current state just as it was. The film features music and poetry by Yoshihide Otomo, Michiro Endo, Ryoichi Wago and people from Fukushima and other regions of Japan. It was not a typical festival since the organisers had to address questions such as: Would it be ethical to bring people to Fukushima? What about children? And what would it mean to the people of Fukushima if the festival had to be called off after all due to radiation concerns? Throughout the film we see how the lives of people in Fukushima have changed and what the future might look like for the next few generations. Born in 1976, Hikaru Fujii creates video installations that respond to contemporary social problems. He makes use of extensive research and fieldwork investigating existing systems and structures, based on the idea that art is produced out of the intimate relationship between society and history. His work explores modern education and social systems in Japan and Asia as well as the nature of museums and art museums. Events Programme The “triple disaster” of earthquake, tsunami and meltdown energised many people in Japan to become more proactive, vocal and dissenting. Mass anti-nuclear protests were held countrywide in the years following the disaster and smaller scale protests are still widespread. A citizen science movement sprang up in response to the slow release (some claimed withholding) of radiation data, with citizens using their own radiation-measuring devices to measure levels of radioactivity and post that data online. Legal challenges and petitions against nuclear power in Japan point to another tactic used by a citizenry that wishes to reclaim more governance over its environment and safety. Japanese artists have responded with an array of approaches, and have often been at the forefront of dissent and critique. A programme of talks, events and activities included contributors Sabu Kohso, Jason Waite, Anna Santomauro, Kaori Homma, and Kodwo Eshun

Conflict Minerals: Lise Autogena & Joshua Portway, Nabil Ahmed

Advances in technology – from atomic energy to the latest smartphones – are underpinned by a material reality that depends on extracting the planet’s natural ores, driving a global mining industry. While the term “conflict minerals” is most frequently used to describe the situation in Congo, where the mining of valuable minerals fuels violence and armed conflict, across the globe many different types of conflict and tension are unfolding in countries and communities inextricably connected to mining and the minerals trade. How are artistic inquiry and the eco- and geo-political aesthetics of art and film contributing to our understanding of conflict – on varied scales – within countries and communities affected by large-scale Anthropocenic and geopolitical forces. Lise Autogena and Joshua Portway’s film Kuannersuit; Kvanefjeld (2016) is a work in-progress, forming the first part of the artists’ long-term investigation into tensions and conflicts within the small, mostly indigenous, community of Narsaq near the Kvanefjeld plateau in southern Greenland; site of one of the richest rare earth mineral resources and uranium ore deposits in the world. The film portrays a community divided on the issue of uranium mining as a means of gaining autonomy, social progress and financial independence, in a region where traditional ways of living from the land and the sea are struggling to compete with big investments from foreign mining companies. The film explores the difficult decisions and trade-offs faced by a culture seeking to escape a colonial past and define its own identity in a globalised world. Kuannersuit; Kvanefjeld was commissioned by Arts Catalyst. Running concurrently, artist and researcher Nabil Ahmed presents maps, drawings and archival material from his project Inter-Pacific Ring Tribunal (INTERPRT), a three-year spatial investigation of the West Papua/Indonesia conflict towards a series of alternative tribunals on ecocide in the Pacific region. Papua is one of the most bio-diverse areas of the world, with 32 million hectares of tropical rainforest and mangroves, and rich marine reef environments. It is also the site of a long-term conflict between Indonesia and indigenous Papuans seeking self-determination. Central to the conflict is the Grasberg mine, which contains the planet’s largest combined reserve of copper and gold. Ahmed’s painstaking research contributes to building a case of ecocide against the Indonesian state, which includes Indonesian military campaigns of mass killings of indigenous Papuans, soil contamination and deforestation from the Grasberg mine, industrial land grabs and intentional forest fires that together show the deliberate destruction of Papuan social, cultural, and natural environments. A series of discussions and study sessions accompanies the programme, with confirmed participants including exhibiting artists Lise Autogena and Joshua Portway and Nabil Ahmed, lawyer turned artist Jack Tan, curator Ele Carpenter, artist Melanie Jackson, writer and academic Angus Cameron and theorist Jussi Parikka

Revital Cohen & Tuur Van Balen: assemble | standard | minimal

Arts Catalyst and the Schering Foundation presented this new exhibition of work by Revital Cohen and Tuur Van Balen, centred on a major new commission Sterile / Sensei Ichi-gō. The exhibition was curated by Jens Hauser and Nicola Triscott, Arts Catalyst. Sterile / Sensei Ichi-gō draws attention to the ambiguous identity of animals designed as products. It centres on albino goldfish specifically designed to be born without reproductive organs, presented alongside a machine - put in stand-by mode - that is capable of reproducing such sterile fish to demand from pre-extracted sperm and eggs. Other works by the artists showing in this exhibition include the short film Kingyo Kingdom which explores the unique culture of breeders, collectors and connoisseurs at the Japanese national goldfish competition, giving a cultural context to the design and commodification of this species, further explored in Sterile / Sensei Ichi-gō. Sterile / Sensei Ichi-gō and Kingyo Kingdom were commissioned by Arts Catalyst