Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial

Background Trials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to show if daily oral fluoxetine for 6 months after stroke improves functional outcome in an ethnically diverse population. Methods AFFINITY was a randomised, parallel-group, double-blind, placebo-controlled trial done in 43 hospital stroke units in Australia (n=29), New Zealand (four), and Vietnam (ten). Eligible patients were adults (aged ≥18 years) with a clinical diagnosis of acute stroke in the previous 2–15 days, brain imaging consistent with ischaemic or haemorrhagic stroke, and a persisting neurological deficit that produced a modified Rankin Scale (mRS) score of 1 or more. Patients were randomly assigned 1:1 via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20 mg capsules or matching placebo for 6 months. Patients, carers, investigators, and outcome assessors were masked to the treatment allocation. The primary outcome was functional status, measured by the mRS, at 6 months. The primary analysis was an ordinal logistic regression of the mRS at 6 months, adjusted for minimisation variables. Primary and safety analyses were done according to the patient's treatment allocation. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12611000774921. Findings Between Jan 11, 2013, and June 30, 2019, 1280 patients were recruited in Australia (n=532), New Zealand (n=42), and Vietnam (n=706), of whom 642 were randomly assigned to fluoxetine and 638 were randomly assigned to placebo. Mean duration of trial treatment was 167 days (SD 48·1). At 6 months, mRS data were available in 624 (97%) patients in the fluoxetine group and 632 (99%) in the placebo group. The distribution of mRS categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio 0·94, 95% CI 0·76–1·15; p=0·53). Compared with patients in the placebo group, patients in the fluoxetine group had more falls (20 [3%] vs seven [1%]; p=0·018), bone fractures (19 [3%] vs six [1%]; p=0·014), and epileptic seizures (ten [2%] vs two [<1%]; p=0·038) at 6 months. Interpretation Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures. These results do not support the use of fluoxetine to improve functional outcome after stroke

Integrating Community Values and Fostering Interagency Collaboration through Outreach with Interactive GIS Models

The Merced County Association of Governments (MCAG) was chosen by the Federal Highway Administration, U.S. Environmental Protection Agency, and the California Department of Transportation to pilot a new program, Partnership for Integrated Planning (PIP), which aimed to: streamline planning and the project-delivery process; avoid environmental impacts; foster collaboration among planning, transportation, and environmental agencies; and engage the public at the beginning of long-term transportation planning.Merced County provides a challenging test case through rapid population growth, cultural diversity, high unemployment, and increasing conflicts between stewardship of sensitive habitats and prime farmland and demands for transportation improvements and housing.The Partnership for Integrated Planning (PIP) included the development of geographic information system (GIS) tools for modeling growth and environmental impacts to produce real-time maps and tables resulting from policy choices at public meetings. PIP engaged all regionally relevant planning, natural resource, and regulatory agencies in data-sharing exercises to integrate data important to each agency into the scenario testing and planning process. Most importantly, the Merced County Association of Governments (MCAG), which is the coordinating partner in PIP, led an extensive outreach program to engage the community in PIP.To project land-use changes, we adapted UPlan, a rule-based land-use model developed at the University of California at Davis. UPlan incorporates user-controlled policy inputs ranging from general plan map choices, housing densities, and household labor rates to the ranking of environmental amenities. These are combined with user-settable infrastructure growth attractors to distribute population-growth estimates into spatially explicit land-use scenarios. UPlan stores all user-specified assumptions so many scenarios may be tested against one another in a transparent fashion. We evaluated information needs by asking planning agencies which features (such as roads and urban service boundaries) they considered attractions and discouragement factors for growth. Resource agencies were asked what environmental factors should discourage or constrain growth. All agencies were asked to provide all available and relevant data.This shared information resulted in an Environmentally Sensitive Areas (ESA) map and a Prime Agricultural Lands map. These two maps were evaluated at a workshop attended by resource agencies’ representatives, elected officials, and city and county planners. Contributors included over 20 federal, state, and non-governmental organizations.Like most public agencies, MCAG has historically solicited public input for regional transportation planning from a few community workshops. For example, in 2001 the agency held seven workshops for its previous plan. Under PIP, MCAG held 20-32 meetings each quarter, for a total of 100+ public meetings in 18 months. In addition, MCAG replaced the previous narrow focus on transportation by asking county residents to develop a vision for land use, natural resources, and transportation throughout their community. MCAG mastered the use of UPlan and accompanying environmental data and improved substantially on both throughout the course of these public meetings.Historically, transportation-plan approval has run into considerable public and agency opposition. Federal officials in the last decade have attempted to streamline the National Environmental Policy Act (NEPA), California Environmental Quality Act (CEQA, which is California’s NEPA equivalent), and other permitting procedures. A goal of PIP was to find a method for responsibly arriving at a consensus plan with less conflict, particularly in the environmental-review phase. The Regional Transportation Plan was approved by the MCAG Governing Board and received no opposition during the CEQA Environmental Impact Report (EIR) public-comment period.Results of the Partnership for Integrated Planning model include:* 800 percent increase in public participation in the transportation-planning process * 89 percent of participants said they enjoyed the PIP project * 89.1 percent of participants said they learned more about transportation issues * 30 percent increase in awareness of the Regional Transportation Plan (RTP) among all county residents * New issues brought to the surface from county groups who had not previously participated in the process * Better relationships were built at both the county and city level among civic organizations, agencies, and residents * RTP was approved by the MCAG Governing Board and received no opposition during public-comment periods * Development of an Environmentally Sensitive Areas map based on shared information from a variety of resource- agency databases * Development of a Prime Agricultural Lands map based on input and information from a variety of agricultural interestsFurther research is needed on the portability of this information and this tool-centered collaborative approach. Adjacent counties with similar needs are prime candidates for study. In addition, future projects should include measures of the social and political planning decision network structures existing before and after the conduct of such projects

Integrating Community Values and Fostering Interagency Collaboration through Outreach with Interactive GIS Models

The Merced County Association of Governments (MCAG) was chosen by the Federal Highway Administration, U.S. Environmental Protection Agency, and the California Department of Transportation to pilot a new program, Partnership for Integrated Planning (PIP), which aimed to: streamline planning and the project-delivery process; avoid environmental impacts; foster collaboration among planning, transportation, and environmental agencies; and engage the public at the beginning of long-term transportation planning.Merced County provides a challenging test case through rapid population growth, cultural diversity, high unemployment, and increasing conflicts between stewardship of sensitive habitats and prime farmland and demands for transportation improvements and housing.The Partnership for Integrated Planning (PIP) included the development of geographic information system (GIS) tools for modeling growth and environmental impacts to produce real-time maps and tables resulting from policy choices at public meetings. PIP engaged all regionally relevant planning, natural resource, and regulatory agencies in data-sharing exercises to integrate data important to each agency into the scenario testing and planning process. Most importantly, the Merced County Association of Governments (MCAG), which is the coordinating partner in PIP, led an extensive outreach program to engage the community in PIP.To project land-use changes, we adapted UPlan, a rule-based land-use model developed at the University of California at Davis. UPlan incorporates user-controlled policy inputs ranging from general plan map choices, housing densities, and household labor rates to the ranking of environmental amenities. These are combined with user-settable infrastructure growth attractors to distribute population-growth estimates into spatially explicit land-use scenarios. UPlan stores all user-specified assumptions so many scenarios may be tested against one another in a transparent fashion. We evaluated information needs by asking planning agencies which features (such as roads and urban service boundaries) they considered attractions and discouragement factors for growth. Resource agencies were asked what environmental factors should discourage or constrain growth. All agencies were asked to provide all available and relevant data.This shared information resulted in an Environmentally Sensitive Areas (ESA) map and a Prime Agricultural Lands map. These two maps were evaluated at a workshop attended by resource agencies’ representatives, elected officials, and city and county planners. Contributors included over 20 federal, state, and non-governmental organizations.Like most public agencies, MCAG has historically solicited public input for regional transportation planning from a few community workshops. For example, in 2001 the agency held seven workshops for its previous plan. Under PIP, MCAG held 20-32 meetings each quarter, for a total of 100+ public meetings in 18 months. In addition, MCAG replaced the previous narrow focus on transportation by asking county residents to develop a vision for land use, natural resources, and transportation throughout their community. MCAG mastered the use of UPlan and accompanying environmental data and improved substantially on both throughout the course of these public meetings.Historically, transportation-plan approval has run into considerable public and agency opposition. Federal officials in the last decade have attempted to streamline the National Environmental Policy Act (NEPA), California Environmental Quality Act (CEQA, which is California’s NEPA equivalent), and other permitting procedures. A goal of PIP was to find a method for responsibly arriving at a consensus plan with less conflict, particularly in the environmental-review phase. The Regional Transportation Plan was approved by the MCAG Governing Board and received no opposition during the CEQA Environmental Impact Report (EIR) public-comment period.Results of the Partnership for Integrated Planning model include:* 800 percent increase in public participation in the transportation-planning process * 89 percent of participants said they enjoyed the PIP project * 89.1 percent of participants said they learned more about transportation issues * 30 percent increase in awareness of the Regional Transportation Plan (RTP) among all county residents * New issues brought to the surface from county groups who had not previously participated in the process * Better relationships were built at both the county and city level among civic organizations, agencies, and residents * RTP was approved by the MCAG Governing Board and received no opposition during public-comment periods * Development of an Environmentally Sensitive Areas map based on shared information from a variety of resource- agency databases * Development of a Prime Agricultural Lands map based on input and information from a variety of agricultural interestsFurther research is needed on the portability of this information and this tool-centered collaborative approach. Adjacent counties with similar needs are prime candidates for study. In addition, future projects should include measures of the social and political planning decision network structures existing before and after the conduct of such projects

Integrating Community Values and Fostering Interagency Collaboration through Outreach with Interactive GIS Models

The Merced County Association of Governments (MCAG) was chosen by the Federal Highway Administration, U.S. Environmental Protection Agency, and the California Department of Transportation to pilot a new program, Partnership for Integrated Planning (PIP), which aimed to: streamline planning and the project-delivery process; avoid environmental impacts; foster collaboration among planning, transportation, and environmental agencies; and engage the public at the beginning of long-term transportation planning. Merced County provides a challenging test case through rapid population growth, cultural diversity, high unemployment, and increasing conflicts between stewardship of sensitive habitats and prime farmland and demands for transportation improvements and housing. The Partnership for Integrated Planning (PIP) included the development of geographic information system (GIS) tools for modeling growth and environmental impacts to produce real-time maps and tables resulting from policy choices at public meetings. PIP engaged all regionally relevant planning, natural resource, and regulatory agencies in data-sharing exercises to integrate data important to each agency into the scenario testing and planning process. Most importantly, the Merced County Association of Governments (MCAG), which is the coordinating partner in PIP, led an extensive outreach program to engage the community in PIP. To project land-use changes, we adapted UPlan, a rule-based land-use model developed at the University of California at Davis. UPlan incorporates user-controlled policy inputs ranging from general plan map choices, housing densities, and household labor rates to the ranking of environmental amenities. These are combined with user-settable infrastructure growth attractors to distribute population-growth estimates into spatially explicit land-use scenarios. UPlan stores all user-specified assumptions so many scenarios may be tested against one another in a transparent fashion. We evaluated information needs by asking planning agencies which features (such as roads and urban service boundaries) they considered attractions and discouragement factors for growth. Resource agencies were asked what environmental factors should discourage or constrain growth. All agencies were asked to provide all available and relevant data. This shared information resulted in an Environmentally Sensitive Areas (ESA) map and a Prime Agricultural Lands map. These two maps were evaluated at a workshop attended by resource agencies’ representatives, elected officials, and city and county planners. Contributors included over 20 federal, state, and non-governmental organizations. Like most public agencies, MCAG has historically solicited public input for regional transportation planning from a few community workshops. For example, in 2001 the agency held seven workshops for its previous plan. Under PIP, MCAG held 20-32 meetings each quarter, for a total of 100+ public meetings in 18 months. In addition, MCAG replaced the previous narrow focus on transportation by asking county residents to develop a vision for land use, natural resources, and transportation throughout their community. MCAG mastered the use of UPlan and accompanying environmental data and improved substantially on both throughout the course of these public meetings. Historically, transportation-plan approval has run into considerable public and agency opposition. Federal officials in the last decade have attempted to streamline the National Environmental Policy Act (NEPA), California Environmental Quality Act (CEQA, which is California’s NEPA equivalent), and other permitting procedures. A goal of PIP was to find a method for responsibly arriving at a consensus plan with less conflict, particularly in the environmental-review phase. The Regional Transportation Plan was approved by the MCAG Governing Board and received no opposition during the CEQA Environmental Impact Report (EIR) public-comment period. Results of the Partnership for Integrated Planning model include: * 800 percent increase in public participation in the transportation-planning process * 89 percent of participants said they enjoyed the PIP project * 89.1 percent of participants said they learned more about transportation issues * 30 percent increase in awareness of the Regional Transportation Plan (RTP) among all county residents * New issues brought to the surface from county groups who had not previously participated in the process * Better relationships were built at both the county and city level among civic organizations, agencies, and residents * RTP was approved by the MCAG Governing Board and received no opposition during public-comment periods * Development of an Environmentally Sensitive Areas map based on shared information from a variety of resource- agency databases * Development of a Prime Agricultural Lands map based on input and information from a variety of agricultural interests Further research is needed on the portability of this information and this tool-centered collaborative approach. Adjacent counties with similar needs are prime candidates for study. In addition, future projects should include measures of the social and political planning decision network structures existing before and after the conduct of such projects.UCD-ITS-RR-05-34, Civil Engineering

957-P: Continuous Glucose Monitoring in Patients with End-Stage Kidney Disease and Burnt-Out Diabetes

Patients with long-standing type 2 diabetes and end-stage kidney disease (ESKD) on dialysis may experience resolution of their hyperglycemia, as defined by an HbA1c 6 months. All subjects wore a blinded Dexcom G6 CGM for 10 days. Their clinical characteristics and CGM metrics are shown in Table 1. Conclusion: CGM provides better assessment of glycemic excursions, compared to HbA1c, in patients with ESKD and diabetes. Most patients with burnt-out diabetes (HbA1c <6.5%, off therapy) have frequent and significant hyperglycemic excursions as detected by CGM. Further research will need to examine whether these excursions require pharmacotherapy. Disclosure C.Kaminski: None. R.J.Galindo: Consultant; Novo Nordisk, Eli Lilly and Company, Sanofi, Pfizer Inc., Bayer Inc., WW (Weight Watchers), Research Support; Novo Nordisk, Eli Lilly and Company, Dexcom, Inc. Z.E.Zabala: None. B.Moazzami: None. A.Y.G.Gerges: None. R.G.Mccoy: Consultant; Emmi. L.Peng: None. G.Umpierrez: Research Support; Abbott, Dexcom, Inc., Baxter. Funding Jacob's Fund for Educatio

Assessment of Glycemic Control by Continuous Glucose Monitoring, Hemoglobin A1c, Fructosamine, and Glycated Albumin in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes

Patients with diabetes and end-stage kidney disease (ESKD) may experience "burnt-out diabetes," defined as having an HbA1c value 6 months. We aim to assess glycemic control by continuous glucose monitoring (Dexcom G6 CGM) metrics and glycemic markers in ESKD patients on hemodialysis with burnt-out diabetes. In this pilot prospective study, glycemic control was assessed by continuous glucose monitoring (CGM), HbA1c measures, and glycated albumin and fructosamine measurements in patients with burnt-out diabetes (n = 20) and without a history of diabetes (n = 20). Patients with burnt-out diabetes had higher CGM-measured daily glucose levels, lower percent time in the range 70-180 mg/dL, higher percent time above range (>250 mg/dL), and longer duration of hyperglycemia >180 mg/dL (hours/day) compared with patients without diabetes (all P < 0.01). HbA1c and fructosamine levels were similar; however, patients with burnt-out diabetes had higher levels of glycated albumin than did patients without diabetes. The use of CGM demonstrated that patients with burnt-out diabetes have significant undiagnosed hyperglycemia. CGM and glycated albumin provide better assessment of glycemic control than do values of HbA1c and fructosamine in patients with ESKD