Background: Electronic Case Report Forms (eCRFs) are increasingly chosen by investigators and sponsors of clinical research instead of the traditional pen-and-paper data collection (pCRFs). Previous studies suggested that eCRFs avoided mistakes, shortened the duration of clinical studies and reduced data collection costs. Methods: Our objectives were to describe and contrast both objective and subjective efficiency of pCRF and eCRF use in clinical studies. A total of 27 studies (11 eCRF, 16 pCRF) sponsored by the Paris hospital consortium, conducted and completed between 2001 and 2011 were included. Questionnaires were emailed to investigators of those studies, as well as clinical research associates and data managers working in Paris hospitals, soliciting their level of satisfaction and preferences for eCRFs and pCRFs. Mean costs and timeframes were compared using bootstrap methods, linear and logistic regression. Results: The total cost per patient was 374€ ±351 with eCRFs vs. 1,135€ ±1,234 with pCRFs. Time between the opening of the first center and the database lock was 31.7 months Q1 = 24.6; Q3 = 42.8 using eCRFs, vs. 39.8 months Q1 = 31.7; Q3 = 52.2 with pCRFs (p = 0.11). Electronic CRFs were globally preferred by all (31/72 vs. 15/72 for paper) for easier monitoring and improved data quality. Conclusions: This study found that eCRFs and pCRFs are used in studies with different patient numbers, center numbers and risk. The first ones are more advantageous in large, low–risk studies and gain support from a majority of stakeholders.

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.

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: 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!).

Thousands of mental health (MH) applications are currently available. Suicidal behavior prevention could benefit from such tools, but few have been evaluated. StopBlues (SB) is an app- and web-based intervention for suicide primary prevention for the French general population. Our objectives were to better understand who users of e-health tools for suicide prevention are by describing SB users' characteristics and their use of the tool, engagement and satisfaction along with the factors associated with the latter two. Age, gender, socioeconomic status (SES), and MH were collected from users who registered to SB between March 2018 and February 2020. MH was self-assessed with validated questionnaires on global MH, depression, anxiety and suicide risk. Use of SB was assessed through functionalities users interacted with (questionnaires, moodtrackers and/or safety plan). Engagement was calculated between date of registration and last interaction with those functionalities. Satisfaction was assessed through a dedicated survey between May 2019 to June 2020. Regression models studied the factors associated with satisfaction and duration of engagement. 10,792 people registered to SB during the study period. Two-thirds were women, mean age was was 38·5 years old (SD = 13·8), and 53·9 % lived in municipalities from the two highest SES quintiles. 47·8 % presented a risk of moderately severe or severe depression, and 27·2 % of severe anxiety. 23 % used the app for more than a day, with a mean duration engagement of 69 days (SD = 105). 96·4 % engaged at least once with either self-assessment questionnaires/moodtrackers or the safety plan, and 21·5 % interacted with both. 413 users completed the satisfaction survey and mean satisfaction was 61·6/100 (SD = 24·7). E-health tools for primary suicide prevention appear to be useful for users but close considerations to gender and age should be made when developing such tools. French National Public Health Agency, Santé Publique France (grant 026/14).

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.