Evaluation of a pro-recovery training intervention (REFOCUS-RETAFORM) in specialist mental health services across France: stepped-wedge cluster randomised controlled trial protocol

BackgroundWhile recovery orientation is national policy in many countries, evidence remains limited for the effectiveness at a service level. This paper describes the protocol for implementing a pro-recovery training intervention (REFOCUS-RETAFORM) in specialist mental health services across France. The aim is to evaluate whether REFOCUS-RETAFORM plus usual care leads to improved outcomes for adolescent and adult mental health service users compared with usual care alone.MethodsA two-step stepped wedge cluster randomised controlled trial will be conducted, with a nested qualitative sub-study exploring stakeholders’ views on changes in staff-user relationships and implementation influences. The REFOCUS-RETAFORM intervention is a training intervention for mental health staff, to develop recovery-promoting relationships and pro-recovery working practices. Clusters are services, which transition sequentially from control to intervention condition in a randomised order. Eight clusters are randomised to deliver REFOCUS-RETAFORM in year one and eight clusters in year two. Each cluster delivers REFOCUS-RETAFORM to two teams from their organisation (32 teams in total). Participants are a) service users aged 13–65 years attending services implementing REFOCUS-RETAFORM, and b) staff receiving the intervention. The primary outcome is the Questionnaire about the Process of Recovery. Secondary outcomes include perceived stigma and coercion, self-stigma and wellbeing for service users, and recovery-orientation for staff. Data will be collected from 540 service users (180 at baseline, 180 at month 12, 180 at month 24) and 220 staff. We will use multilevel mixed-effects models, adjusting for secular trends and thematic analysis for the qualitative interview data.DiscussionFindings will inform the continued transformation of French specialist mental health services toward a recovery orientation

On the way to structure the urban hydrological field: HURRBIS: an attempt to find the good scales for innovative policies for urban drainage in France

HURRBIS is an informal network created in 2006, by the 3 French Observatories of Urban Hydrology: OPUR from Paris area, OTHU from Lyon and ONEVU from Nantes. OPUR, OTHU and ONEVU work mostly on the same topic: they analyse the whole urban water cycle, from the atmosphere to the ground including the in-between steps as water infrastructures and aquatic environment (groundwater and water courses). Part of their budget comes from local authorities, so researchers have to negotiate their research topics considering local management concerns about storm water and wet weather flows. Researches mainly focus on pollutants in urban areas and their impact on the aquatic environment. From an organisational point of view, HURRBIS is a non structural organisation to enhance relations between researchers working on different sites. It aims to become a special place for researchers and city engineers to share their needs and work on solutions to improve urban water management. It is supposed to favour communication between both parts and help to link scientific questions to management issues. Scientifically, the HURRBIS network is an opportunity for the observatories to put in common their local studies and to share methods, data and outcomes. All in all, HURRBIS questions the innovation process considering governance changes: how can research teams and programs help to change management practices dealing with this background? Is there a good scale to build efficient partnerships? In brief, main issues discussed in the paper are: HURRBIS as a network to link scientific issues to water management concerns An intent to share at a wider scale local territories' data and programs A will to find the good scale for innovation policies

On the way to structure the urban hydrological field: HURRBIS: an attempt to find the good scales for innovative policies for urban drainage in France

HURRBIS is an informal network created in 2006, by the 3 French Observatories of Urban Hydrology: OPUR from Paris area, OTHU from Lyon and ONEVU from Nantes. OPUR, OTHU and ONEVU work mostly on the same topic: they analyse the whole urban water cycle, from the atmosphere to the ground including the in-between steps as water infrastructures and aquatic environment (groundwater and water courses). Part of their budget comes from local authorities, so researchers have to negotiate their research topics considering local management concerns about storm water and wet weather flows. Researches mainly focus on pollutants in urban areas and their impact on the aquatic environment. From an organisational point of view, HURRBIS is a non structural organisation to enhance relations between researchers working on different sites. It aims to become a special place for researchers and city engineers to share their needs and work on solutions to improve urban water management. It is supposed to favour communication between both parts and help to link scientific questions to management issues. Scientifically, the HURRBIS network is an opportunity for the observatories to put in common their local studies and to share methods, data and outcomes. All in all, HURRBIS questions the innovation process considering governance changes: how can research teams and programs help to change management practices dealing with this background? Is there a good scale to build efficient partnerships? In brief, main issues discussed in the paper are: HURRBIS as a network to link scientific issues to water management concerns An intent to share at a wider scale local territories' data and programs A will to find the good scale for innovation policies

On the way to structure the urban hydrological field: HURRBIS: an attempt to find the good scales for innovative policies for urban drainage in France

HURRBIS is an informal network created in 2006, by the 3 French Observatories of Urban Hydrology: OPUR from Paris area, OTHU from Lyon and ONEVU from Nantes. OPUR, OTHU and ONEVU work mostly on the same topic: they analyse the whole urban water cycle, from the atmosphere to the ground including the in-between steps as water infrastructures and aquatic environment (groundwater and water courses). Part of their budget comes from local authorities, so researchers have to negotiate their research topics considering local management concerns about storm water and wet weather flows. Researches mainly focus on pollutants in urban areas and their impact on the aquatic environment. From an organisational point of view, HURRBIS is a non structural organisation to enhance relations between researchers working on different sites. It aims to become a special place for researchers and city engineers to share their needs and work on solutions to improve urban water management. It is supposed to favour communication between both parts and help to link scientific questions to management issues. Scientifically, the HURRBIS network is an opportunity for the observatories to put in common their local studies and to share methods, data and outcomes. All in all, HURRBIS questions the innovation process considering governance changes: how can research teams and programs help to change management practices dealing with this background? Is there a good scale to build efficient partnerships? In brief, main issues discussed in the paper are: HURRBIS as a network to link scientific issues to water management concerns An intent to share at a wider scale local territories' data and programs A will to find the good scale for innovation policies

On the way to structure the urban hydrological field: HURRBIS: an attempt to find the good scales for innovative policies for urban drainage in France

HURRBIS is an informal network created in 2006, by the 3 French Observatories of Urban Hydrology: OPUR from Paris area, OTHU from Lyon and ONEVU from Nantes. OPUR, OTHU and ONEVU work mostly on the same topic: they analyse the whole urban water cycle, from the atmosphere to the ground including the in-between steps as water infrastructures and aquatic environment (groundwater and water courses). Part of their budget comes from local authorities, so researchers have to negotiate their research topics considering local management concerns about storm water and wet weather flows. Researches mainly focus on pollutants in urban areas and their impact on the aquatic environment. From an organisational point of view, HURRBIS is a non structural organisation to enhance relations between researchers working on different sites. It aims to become a special place for researchers and city engineers to share their needs and work on solutions to improve urban water management. It is supposed to favour communication between both parts and help to link scientific questions to management issues. Scientifically, the HURRBIS network is an opportunity for the observatories to put in common their local studies and to share methods, data and outcomes. All in all, HURRBIS questions the innovation process considering governance changes: how can research teams and programs help to change management practices dealing with this background? Is there a good scale to build efficient partnerships? In brief, main issues discussed in the paper are: HURRBIS as a network to link scientific issues to water management concerns An intent to share at a wider scale local territories' data and programs A will to find the good scale for innovation policies

On the way to structure the urban hydrological field: HURRBIS: an attempt to find the good scales for innovative policies for urban drainage in France

HURRBIS is an informal network created in 2006, by the 3 French Observatories of Urban Hydrology: OPUR from Paris area, OTHU from Lyon and ONEVU from Nantes. OPUR, OTHU and ONEVU work mostly on the same topic: they analyse the whole urban water cycle, from the atmosphere to the ground including the in-between steps as water infrastructures and aquatic environment (groundwater and water courses). Part of their budget comes from local authorities, so researchers have to negotiate their research topics considering local management concerns about storm water and wet weather flows. Researches mainly focus on pollutants in urban areas and their impact on the aquatic environment. From an organisational point of view, HURRBIS is a non structural organisation to enhance relations between researchers working on different sites. It aims to become a special place for researchers and city engineers to share their needs and work on solutions to improve urban water management. It is supposed to favour communication between both parts and help to link scientific questions to management issues. Scientifically, the HURRBIS network is an opportunity for the observatories to put in common their local studies and to share methods, data and outcomes. All in all, HURRBIS questions the innovation process considering governance changes: how can research teams and programs help to change management practices dealing with this background? Is there a good scale to build efficient partnerships? In brief, main issues discussed in the paper are: HURRBIS as a network to link scientific issues to water management concerns An intent to share at a wider scale local territories' data and programs A will to find the good scale for innovation policies

Effectiveness of golimumab intensification in ulcerative colitis: A multicentric prospective study

Introduction: Loss of response to golimumab occurs in nearly 40% of patients with ulcerative colitis (UC). Unlike others anti-TNF, no study has reported a correlation between serum golimumab level and response to drug intensification. The objective of this study was to evaluate the effectiveness and safety of golimumab intensification and to identify the best threshold of serum golimumab before drug intensification predictive of response.Patients and methods: We included all consecutive patients with active UC with loss of response to golimumab in a prospective multicentric cohort study. Patients with loss of response at 50 mg q4 weeks (W) and 100 mg q4W underwent therapeutic intensification at 100 mg q4W and 100 mg q2W, respectively. Effectiveness and safety were assessed between Weeks 2 and 4 (visit 2) and between Weeks 4 and 8 (visit 3) after intensification. Serum level and anti-golimumab antibodies were evaluated at each medical visit (Lisa Tracker, Theradiag France).Results: A total of 47 UC patients (Female, 50%; median age, 39 years (IQR, 27-52)) treated with golimumab for a median of 20.4 weeks (IQR, 10.7-38.3) were included. The median partial Mayo score was 6 (IQR, 5-7), and the median endoscopic Mayo score was 3 (IQR, 2-3). The median golimumab serum level before intensification was 2.23 μg/mL (IQR, 1.02-3.96) and only one patient (2.1%) had anti-drug antibodies. At Visit 2 (Week 2-4), 40% patients experienced clinical response, 10% clinical remission, 33% endoscopic response and 23% endoscopic remission. At Visit 3 (Week 4-8), 44% of patients had clinical response, 22% of patients had clinical remission, 45% of patients had endoscopic response, and 41% of patients had endoscopic remission. The median golimumab levels before intensification do not differ between responders and non-responders (2.13 μg/ml (0.76-2.76) and 3.37 μg/ml (IQR, 1.08-4.67), respectively; p = 0.14) assessed at Visit 3. Golimumab intensification to 100 mg q4W (vs q2W) (OR 1.98, 95% CI [1.06-3.70]; p = 0.032) was significantly associated with clinical remission at Visit 3. Serum drug level at baseline or the presence of antidrug antibodies were not associated with clinical or endoscopic remission/response. Two serious adverse events (one infection and one UC flare) were reported during the 24-week follow-up.Conclusion: In this prospective multicentric study, half of patients recaptured response following golimumab intensification in UC. Therapeutic drug monitoring did not predict response after optimisation of golimumab

Effectiveness of golimumab intensification in ulcerative colitis: A multicentric prospective study

Introduction: Loss of response to golimumab occurs in nearly 40% of patients with ulcerative colitis (UC). Unlike others anti-TNF, no study has reported a correlation between serum golimumab level and response to drug intensification. The objective of this study was to evaluate the effectiveness and safety of golimumab intensification and to identify the best threshold of serum golimumab before drug intensification predictive of response.Patients and methods: We included all consecutive patients with active UC with loss of response to golimumab in a prospective multicentric cohort study. Patients with loss of response at 50 mg q4 weeks (W) and 100 mg q4W underwent therapeutic intensification at 100 mg q4W and 100 mg q2W, respectively. Effectiveness and safety were assessed between Weeks 2 and 4 (visit 2) and between Weeks 4 and 8 (visit 3) after intensification. Serum level and anti-golimumab antibodies were evaluated at each medical visit (Lisa Tracker, Theradiag France).Results: A total of 47 UC patients (Female, 50%; median age, 39 years (IQR, 27-52)) treated with golimumab for a median of 20.4 weeks (IQR, 10.7-38.3) were included. The median partial Mayo score was 6 (IQR, 5-7), and the median endoscopic Mayo score was 3 (IQR, 2-3). The median golimumab serum level before intensification was 2.23 μg/mL (IQR, 1.02-3.96) and only one patient (2.1%) had anti-drug antibodies. At Visit 2 (Week 2-4), 40% patients experienced clinical response, 10% clinical remission, 33% endoscopic response and 23% endoscopic remission. At Visit 3 (Week 4-8), 44% of patients had clinical response, 22% of patients had clinical remission, 45% of patients had endoscopic response, and 41% of patients had endoscopic remission. The median golimumab levels before intensification do not differ between responders and non-responders (2.13 μg/ml (0.76-2.76) and 3.37 μg/ml (IQR, 1.08-4.67), respectively; p = 0.14) assessed at Visit 3. Golimumab intensification to 100 mg q4W (vs q2W) (OR 1.98, 95% CI [1.06-3.70]; p = 0.032) was significantly associated with clinical remission at Visit 3. Serum drug level at baseline or the presence of antidrug antibodies were not associated with clinical or endoscopic remission/response. Two serious adverse events (one infection and one UC flare) were reported during the 24-week follow-up.Conclusion: In this prospective multicentric study, half of patients recaptured response following golimumab intensification in UC. Therapeutic drug monitoring did not predict response after optimisation of golimumab

Effectiveness of golimumab intensification in ulcerative colitis: A multicentric prospective study

Introduction: Loss of response to golimumab occurs in nearly 40% of patients with ulcerative colitis (UC). Unlike others anti-TNF, no study has reported a correlation between serum golimumab level and response to drug intensification. The objective of this study was to evaluate the effectiveness and safety of golimumab intensification and to identify the best threshold of serum golimumab before drug intensification predictive of response.Patients and methods: We included all consecutive patients with active UC with loss of response to golimumab in a prospective multicentric cohort study. Patients with loss of response at 50 mg q4 weeks (W) and 100 mg q4W underwent therapeutic intensification at 100 mg q4W and 100 mg q2W, respectively. Effectiveness and safety were assessed between Weeks 2 and 4 (visit 2) and between Weeks 4 and 8 (visit 3) after intensification. Serum level and anti-golimumab antibodies were evaluated at each medical visit (Lisa Tracker, Theradiag France).Results: A total of 47 UC patients (Female, 50%; median age, 39 years (IQR, 27-52)) treated with golimumab for a median of 20.4 weeks (IQR, 10.7-38.3) were included. The median partial Mayo score was 6 (IQR, 5-7), and the median endoscopic Mayo score was 3 (IQR, 2-3). The median golimumab serum level before intensification was 2.23 μg/mL (IQR, 1.02-3.96) and only one patient (2.1%) had anti-drug antibodies. At Visit 2 (Week 2-4), 40% patients experienced clinical response, 10% clinical remission, 33% endoscopic response and 23% endoscopic remission. At Visit 3 (Week 4-8), 44% of patients had clinical response, 22% of patients had clinical remission, 45% of patients had endoscopic response, and 41% of patients had endoscopic remission. The median golimumab levels before intensification do not differ between responders and non-responders (2.13 μg/ml (0.76-2.76) and 3.37 μg/ml (IQR, 1.08-4.67), respectively; p = 0.14) assessed at Visit 3. Golimumab intensification to 100 mg q4W (vs q2W) (OR 1.98, 95% CI [1.06-3.70]; p = 0.032) was significantly associated with clinical remission at Visit 3. Serum drug level at baseline or the presence of antidrug antibodies were not associated with clinical or endoscopic remission/response. Two serious adverse events (one infection and one UC flare) were reported during the 24-week follow-up.Conclusion: In this prospective multicentric study, half of patients recaptured response following golimumab intensification in UC. Therapeutic drug monitoring did not predict response after optimisation of golimumab