Anaïs Le Jeannic

Background/Objectives: Congenital clubfoot is the most frequent malformation in pediatric orthopedics. In France, two treatments can be proposed: the Ponseti method and the functional method. The objective was to conduct a medico-economic and -social evaluation of those methods. Methods: Medico-economic: a cost-consequences analysis was undertaken from the societal perspective, based on the Dimeglio score at 24 months in four pediatric hospitals. Medico-social: interviews were conducted with parents (n = 16) and healthcare professionals (n = 16). Results: One hundred patients were included between January 2014 and December 2016. Whatever the treatment method, over 90% of patients presented with benign clubfoot (i.e., Dimeglio score < 5/20) at 24 months, based on multiply imputed estimates. The Functional method was associated with higher direct medical and non-medical costs (€3340–4061 vs. 889–2318; €6275–5968 vs. 576–726), and indirect costs (€15,441–4672 vs. 1416–1786), contrary to out-of-pocket expenses (€0–1 vs. €322–546). Family testimonies underscored the importance of communication from healthcare providers to reassure and guide parents. Although the choice is influenced by professionals, trust and active engagement of families are essential for adherence to treatment and its long-term success. The Ponseti method combined effectiveness with a lower perceived burden for families. Conclusions: The Ponseti method was the costliest for parents, yet more manageable. However, the most important factor is to choose a method adapted to the family in order to achieve the best degree of compliance.

With over one million deaths per year in the world, suicide is a major public health problem that could be significantly reduced by effective prevention programs. E-health tools are of particular interest for primary prevention as they can address a broad population including people unaware of their own risk and provide information and help without the fear of stigma. Our main objective was to define the overall characteristics of an e-health tool for suicide primary prevention in the French general population by defining the characteristics of the IT features; the content of the information delivered; the best way to structure it; and how it should be relayed and by whom. The research was carried out through a literature review and a co-construction phase with stakeholders. Four types of strategies may guide the construction of e-health tools for suicide primary prevention: education and awareness, (self-)screening, accessing support, and mental health coping. They should be accessible on different devices to reach the most users, and language and content should be adapted to the target population and to the issue being addressed. Finally, the tool should be consistent with ethical and quality best practices. The e-health tool StopBlues was developed following those recommendations.

BACKGROUND With more than a million deaths per year and nearly one out of two people with suicidal thoughts not receiving any form of care in high-income countries, suicide is a major public health problem and a cause of avoidable mortality which could be significantly reduced by effective prevention programs. E-health tools present the advantage of addressing a broad population including people unaware of their potential risk of suicide, and provide an opportunity to look for information and help without fearing stigmatization. This could make them an effective tool for primary prevention programs, even in some hard-to-reach populations. OBJECTIVE Our main objective was to define the overall characteristics of an e-health tool for the primary prevention of suicide in the French general population. Intermediate objectives were to define 1/ the characteristics of the IT features; 2/ the content of the information delivered; 3/ the best way to structure that information; and 4/ how the information should be relayed and by whom. METHODS The research was carried out in two phases: 1/ a literature review was conducted to gather knowledge on existing interventions that may already have proved their effectiveness, and on guidelines for suicide prevention programs; and 2/ a co-construction phase was carried out through a participative process (focus groups and interviews) with stakeholders, including the target population, to ensure that the needs of individuals would be met. RESULTS E-health tools for suicide primary prevention in the general population may be constructed around four types of strategies: education and awareness, (self-)screening, accessing support, and mental health coping. They should be accessible on different devices to reach the most users, and language and content should be adapted to the target population and to the issue being addressed. Finally, the tool should be consistent with ethical and quality best practices. StopBlues was developed following those recommendations and is the first of its kind in France, an e-health tool for prevention with numerous functionalities to help people with psychological distress. CONCLUSIONS E-health tools for suicide prevention offer many advantages when adapted to the need of the population: 1/ great accessibility, 2/ users’ anonymity with reduction of shame, 3/ adaptation of health interventions to new cultural practices, and 4/ the possibility to regroup in one tool many functionalities. Those can be an important part of users’ empowerment process, by helping them manage their illness on their own and gain autonomy, therefore improving their well-being. However, it is important to remember that this type of tools should be developed not to make up for the potential lack of healthcare services but to propose a reliable tool to help people evaluate themselves and be directed to the healthcare system at early stages of their illness. CLINICALTRIAL Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population (PRINTEMPS) NCT03565562 https://clinicaltrials.gov/ct2/show/NCT03565562 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-020-04464-2

Background and Purpose: Additional therapy may improve poststroke outcomes. Self-rehabilitation is a useful means to increase rehabilitation time. Mechanized systems are usual means to extend time for motor training. The primary aim was to compare the effects of self-rehabilitation using a mechanized device with control self-exercises on upper extremity impairment in patients with stroke. Methods: Phase III, parallel, concealed allocation, randomized controlled, multicenter trial, with 12-month follow-up. Patients aged 18 to 80 years, 3 weeks to 3 months poststroke with a Fugl-Meyer Assessment score of 10 to 40 points, were randomized to the Exo or control groups. All undertook two 30-minute self-rehabilitation sessions/day, 5 days/wk for 4 weeks in addition to usual rehabilitation. The Exo group performed games-based exercises using a gravity-supported mechanical exoskeleton (Armeo Spring). The control group performed stretching plus basic active exercises. Primary outcome was change in upper extremity Fugl-Meyer Assessment score at 4 weeks. Results: Two hundred fifteen participants were randomly allocated to the Exo group (107) or the control group (108). Mean age (SD), 58.3 (13.6) years; mean time poststroke, 54.8 (22.1) days; and mean baseline Fugl-Meyer Assessment score, 26.1 (9.5). There was no between-group difference in mean change in Fugl-Meyer Assessment score following the intervention: 13.3 (9.0) in the Exo group and 11.8 (8.8) in the control group ( P =0.22). There were no significant between-group differences in changes for any of the other outcomes at any time point (except for perception of the self-rehabilitation). There was no between-group difference in cost utility at 12 months. Conclusions: In patients with moderate-to-severe impairment in the subacute phase of stroke, the purchase and use of complex devices to provide additional upper limb training may not be necessary: simply educating patients to regularly move and stretch their limbs appears sufficient. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01383512.

Background: Non-medical data, such as the amount of time that patients and caregivers spend managing their condition, may be relevant when assessing therapeutic strategies. For chronic pediatric conditions, the time that patients and caregivers spend in seeking and providing care (which are the indirect costs in an economic evaluation) can be significantly different depending on the treatment arm. To explore methods for collecting information on the care burden for caregivers and patients, we investigated whether a patient diary provided additional information compared to retrospective investigator-led interviews and whether a diary that was completed intermittently produced more or less information than a diary completed continually. The main objective of this study was to identify which type of data collection was most effective for measuring the time spent by caregivers and for estimating indirect treatment costs over 9 months. Methods: Start-In! is a randomized controlled trial comparing the efficacy of three strategies of real-time continuous glucose monitoring for 12 months in children and adolescents with type 1 diabetes. We designed an ancillary study to assess methods of collecting information on the time spent by patients and caregivers in managing their condition (indirect costs). Data were entered retrospectively in case report forms (CRFs) by investigators during quarterly follow-up visits, which were supplemented with diaries completed prospectively by children or caregivers either continuously or intermittently. Data about absences from school and work as well as the time that caregivers spent on diabetes care were collected and the three collection methods were compared. Results: At the end of the 9-month study, 42% of the study participants failed to return their diary. For the diaries that were received, less than 10% of expected data were collected versus 82% during investigators'interviews. Based on all the information collected, we calculated that over 9 months, caregivers lost on average 3.9 days of working time (€786) and 4 days of personal time, i.e. the equivalent of €526, and spent around 15 min of time on care per day, i.e. the equivalent of €1700. Conclusions: The CRFs completed by investigators during quarterly visits cannot be replaced by a diary. Completing the diaries appeared to represent an important additional burden to children and their caregivers, and the diaries provided little additional information compared to investigators’ entries in the CRF. Trial registration: ClinicalTrials.gov, NCT00949221. Registered on 30 July 2009. Registry name: Study of Insulin Therapy Augmented by Real Time Sensor in Type 1 Children and Adolescents (START-IN!).

Background: Non-medical data such as patients’ and caregivers’ time can be relevant to assess therapeutic strategies. For chronic pediatric conditions, patients’ and caregivers’ time spent in seeking and providing care (i.e. indirect cost in an economic evaluation) can be significantly different depending on the treatment arm. In order to explore methods to collect information on care burden for caregivers and patients, we investigated whether or not a patient diary provided additional information compared to retrospective investigator-led interviews and whether a diary filled intermittently produced more or less information than a continuous diary. The main objective of this study was to identify which type of data collection was most effective to measure caregivers’ time and estimate indirect treatment costs over a 9-month period. Methods: Start-In! is a randomized controlled trial comparing the efficacy of three strategies of real-time continuous glucose monitoring (CGM) for 12 months in children and adolescents with type 1 diabetes. We designed an ancillary study to assess methods of patients’ and caregivers’ time (indirect costs): data entered was retrospectively in the case report form by investigators during quarterly follow-up visits, with the help of diaries filled prospectively by children or caregivers either continuously or intermittently. Data about absence from school and work as well as caregivers’ time for diabetes care were collected and comparisons carried out between the three collection methods. Results: At the end of the 9-month study, 42% of study participants failed to return their diary. For the diaries that were received, less than 10 were contributive on top of the information entered on 82 patients directly by investigators .Based upon this information, we calculated that over 9 months, caregivers lost on average 3.9 days of working time, (€786), and 4 days of personal time, i.e. the equivalent of €526, as well as around 15 minutes of care per day, i.e. the equivalent of €1,700. Conclusions: Data collection by investigators during quarterly visits cannot be replaced by a diary. The completion of diaries appeared to represent an important additional burden to children and their caregivers and provided limited additional information compared to investigators ‘entries in the CRF. Trial registration: Start-In! trial registry name: Study of Insulin Therapy Augmented by Real Time Sensor IN Type 1 Children and Adolescents (START-IN!). ClinicalTrials.gov Identifier: NCT00949221. Registered on July 30, 2009.

Background: France is one of the Western European countries most affected by suicide, an epidemiological burden and high societal cost of several million euros/year. Several European projects have either implemented web-based interventions for care of mental disorders or recommended online actions which have demonstrated their effectiveness for suicide prevention. The objective of the project was the construction of an application and website to prevent suicide in the general population, with its promotion being supported at the local authority level. Methods: The detailed content of the devices and promotional tools available to local authorities was determined through literature reviews and expert groups (psychiatrists, local authorities’ workers and potential users). Results: An application and website were constructed with two parts: a public interface with videos (psychological suffering, coping strategies and help available), an emergency button, a map with local resources and contact information (psychiatrists, psychologists, associations...), tips and videos to overcome a period of psychological suffering; and a private interface requiring registration giving access to self-assessment questionnaires and a safety plan to fill in case of crisis. 40 local authorities are involved in StopBlues promotion, with a referent each, responsible of contact with our team, and local organization of promotion. Conclusions: Since 04-2018, StopBlues is available at www.stopblues.fr and can be downloaded on iOs and Android. Its promotion is part of a cluster randomized trial with 3 arms: a control group with no promotion, a group with promotion by local authorities, and a group with promotion by local authorities and general practitioner’s waiting room. As promotion could have different intensities depending on budgets and referent’s involvement, we decided to extend it for another year, with local authorities of group control receiving additional financial and organizational support. Key messages: As the first e-health program for suicide primary prevention in the French general population, StopBlues’ main goal is to help people find solutions that suit them and direct them to the right help. Local authorities are a key level to promote primary health prevention programs.

Background: In France the pertinence of including indirect costs in economic evaluations of therapeutic strategies is left to author judgment. However productivity losses represent a significant amount of resources in particular for chronic pediatric conditions when caregivers are involved in addition to patients. In order to explore how best to collect indirect cost information, we investigated whether or not a patient diary provided additional information compared to retrospective investigator-led interviews and whether a diary filled intermittently produced more or less information than a continuous diary. The main objective of this study was to identify which type of data collection was most effective to obtain information on indirect costs over a 9-month study period. Methods : Start-In! is a randomized controlled trial comparing the efficacy of three strategies of real-time continuous glucose monitoring (CGM) for 12 months in children and adolescents with type 1 diabetes. We designed an ancillary study to compare three collection methods of indirect costs: 1) retrospectively by investigators during quarterly follow up visits and prospectively with diaries filled by children or families used 2) either continuously or 3) intermittently. Were collected the amount of information on absence from school and work, and carer time for diabetes cares, and compared to the information given to the investigator during the quarterly follow up visit in the case report form. Results: At the end of the 9-month study 42% participants had not returned their diary, less than 10% of data were collected in patients’ diaries versus 82% in investigators’ filled case report forms. Conclusions: Our study only supports the hypothesis that data collection by investigators during quarterly visits would lead to fewer missing data than a diary, that it be filled up on a trimester or every three months. Diaries might represent an important additional burden to children and their families. Trial registration: Start-In! trial registry name: Study of Insulin Therapy Augmented by Real Time Sensor IN Type 1 Children and Adolescents (START-IN!). ClinicalTrials.gov Identifier: NCT00949221. Registered on July 30, 2009.