BackgroundElectronic 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.MethodsOur 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.ResultsThe 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.ConclusionsThis 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.
Aim To compare the efficacy of three strategies for real‐time continuous glucose monitoring (RT‐CGM) over 12 months in children and adolescents with type 1 diabetes. Methods A French multicenter trial (NCT00949221) with a randomized, controlled, prospective, open, and parallel‐group design was conducted. After 3 months of RT‐CGM, patients were allocated to one of three groups: return to self‐monitoring of blood glucose, continuous CGM (80% of the time), or discontinuous CGM (40% of the time). The primary outcome was hemoglobin A1c (HbA1c) levels from 3 to 12 months. The secondary outcomes were acute metabolic events, hypoglycemia, satisfaction with CGM and cost. Results We included 151 subjects, aged 2 to 17 years, with a mean HbA1c level of 8.5% (SD0.7; 69 mmol/mol). The longitudinal change in HbA1c levels was similar in all three groups, at 3, 6, 9 and 12 months. The medical secondary endpoints did not differ between groups. The rate of severe hypoglycemia was significantly lower than that for the pretreatment year for the entire study population. Subjects reported consistent use and good tolerance of the device, regardless of age or insulin treatment. The use of full‐time RT‐CGM for 3 months costs the national medical insurance system €2629 per patient. Conclusion None of the three long‐term RT‐CGM strategies evaluated in pediatric type 1 diabetes was superior to the others in terms of HbA1c levels. CGM‐use for 3 months decreased rates of severe hypoglycemia. Our results confirm the feasibility of long‐term RT‐CGM‐use and the need to improve educational support for patients and caregivers.
FOREseal did not demonstrate a significant advantage over standard treatment alone.
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 Suicide constitutes a cause of death which could be prevented by e-health programs accessible to the general population. Effective promotion has the potential to maximize the uptake of such programs. However, few e-health programs have been combined with promotion campaigns. The primary objective of this trial is to assess the effectiveness of a tailored promotion, at a local level, of a mobile application and website offering evidence-based content for suicide prevention (the StopBlues program), and to compare the effectiveness of two types of local promotion in terms of their impact on suicidal acts. Secondary objectives focus on the effectiveness of the promotion in terms of the intensity of utilization of the StopBlues program, help-seeking behaviors and the level of psychological impairment of program users. Methods/design This is a three-arm, parallel-group, cluster-randomized controlled trial, with before-and-after observation. Thirty-four clusters, corresponding to geographical areas sharing a common local authority in France, will be included. They will be randomly assigned to one of the following arms with a ratio of 1:1:1: a control group; a basic promotion group in which promotion of the StopBlues program will be done by local authorities; and an intensified promotion group in which basic promotion will be supplemented by an additional one in a general practitioner’s waiting room. The primary outcome measure will be the number of suicidal acts within each cluster over a 12-month period following the launch of the intervention. Baseline data will be collected for each cluster over the 12-month period prior to the trial. Secondary outcomes will include length of use of the StopBlues program, measures of help-seeking behaviors and level of psychological distress among users of the program, as well as the cost-effectiveness and budgetary impact of its promotion. A more sustained promotion by local authorities will also be implemented after 12 months in the control group and assessed using the same outcome measures. Discussion This research should contribute to the sparse evidence base regarding the promotion of e-health programs and will support the wider delivery of the intervention evaluated if proven effective. Trial registration ClinicalTrials.gov, ID: NCT03565562. Registered on 11 June 2018
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: 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 followup 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.
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