scholarly journals Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial

BMJ ◽  
2012 ◽  
Vol 345 (dec12 1) ◽  
pp. e7822-e7822 ◽  
Author(s):  
K. S. Ibler ◽  
G. B. E. Jemec ◽  
T. L. Diepgen ◽  
C. Gluud ◽  
J. Lindschou Hansen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Healthcare Workers ◽  
Randomised Clinical Trial ◽  
Hand Eczema ◽  
Skin Care ◽  
Treatment As Usual ◽  
Care Education ◽  
Individual Counselling ◽  
Versus Treatment

scholarly journals Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Markus Harboe Olsen ◽  
Mathias Lühr Hansen ◽  
Sanam Safi ◽  
Janus Christian Jakobsen ◽  
Gorm Greisen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cerebral Oxygenation ◽  
Good Clinical Practice ◽  
Randomised Clinical Trial ◽  
Systematic Errors ◽  
Data Monitoring ◽  
Random Errors ◽  
Treatment As Usual ◽  
Common Mean ◽  
Central Data

Abstract Background Data monitoring of clinical trials is a tool aimed at reducing the risks of random errors (e.g. clerical errors) and systematic errors, which include misinterpretation, misunderstandings, and fabrication. Traditional ‘good clinical practice data monitoring’ with on-site monitors increases trial costs and is time consuming for the local investigators. This paper aims to outline our approach of time-effective central data monitoring for the SafeBoosC-III multicentre randomised clinical trial and present the results from the first three central data monitoring meetings. Methods The present approach to central data monitoring was implemented for the SafeBoosC-III trial, a large, pragmatic, multicentre, randomised clinical trial evaluating the benefits and harms of treatment based on cerebral oxygenation monitoring in preterm infants during the first days of life versus monitoring and treatment as usual. We aimed to optimise completeness and quality and to minimise deviations, thereby limiting random and systematic errors. We designed an automated report which was blinded to group allocation, to ease the work of data monitoring. The central data monitoring group first reviewed the data using summary plots only, and thereafter included the results of the multivariate Mahalanobis distance of each centre from the common mean. The decisions of the group were manually added to the reports for dissemination, information, correcting errors, preventing furture errors and documentation. Results The first three central monitoring meetings identified 156 entries of interest, decided upon contacting the local investigators for 146 of these, which resulted in correction of 53 entries. Multiple systematic errors and protocol violations were identified, one of these included 103/818 randomised participants. Accordingly, the electronic participant record form (ePRF) was improved to reduce ambiguity. Discussion We present a methodology for central data monitoring to optimise quality control and quality development. The initial results included identification of random errors in data entries leading to correction of the ePRF, systematic protocol violations, and potential protocol adherence issues. Central data monitoring may optimise concurrent data completeness and may help timely detection of data deviations due to misunderstandings or fabricated data.

scholarly journals Prevention of hand eczema: effect of an educational program versus treatment as usual – results of the randomized clinical PREVEX trial

2017 ◽  
Author(s):  
Maja H Fisker ◽  
Niels E Ebbehøj ◽  
Søren Grove Vejlstrup ◽  
Jane Lindschou ◽  
Christian Gluud ◽  
...  
Keyword(s):  
Educational Program ◽  
Hand Eczema ◽  
Treatment As Usual ◽  
Versus Treatment

scholarly journals An Internet-Based Emotion Regulation Intervention Versus no Intervention for Nonsuicidal Self-Injury in Adolescents: Study Protocol for a Feasibility Trial

2020 ◽  
Author(s):  
Britt Reuter Morthorst ◽  
Lotte Rubæk ◽  
Jane Lindschou ◽  
Janus Christian Jakobsen ◽  
Christian Gluud Christian Gluud ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emotion Regulation ◽  
Specific Treatment ◽  
Online Intervention ◽  
Randomised Clinical Trial ◽  
Individual Therapy ◽  
Feasibility Trial ◽  
Treatment Needs ◽  
Treatment As Usual ◽  
Self Injury

Abstract Background: Non-suicidal self-injury (NSSI) has gained increased attention in recent years due to increased prevalence, especially among adolescents. Evidence-based interventions for NSSI are sparse. Emotion regulation individual therapy for adolescents (ERITA) is an online intervention that needs investigation. Non-randomised studies suggest ERITA improves emotion regulations skills and reduces NSSI frequency. Before conducting a large pragmatic randomised clinical trial, we aim to investigate the feasibility of ERITA in Denmark. Methods: A randomised, parallel group feasibility trial comparing ERITA as add on to treatment as usual versus treatment as usual in 30 adolescents age 13-17 years with recurrent NSSI referred to outpatient clinics in The Child and Adolescent Mental Health Services in the Capital Region of Denmark. Feasibility outcomes are 1) completion of follow-up, 2) the fraction of eligible participants who consent to inclusion and randomisation, and 3) compliance with the intervention. Exploratory clinical outcomes such as self-injury frequency and the ability to regulate emotions will be investigated exploratorily. Discussion: Internet-based interventions are assumed to be appealing to adolescents by being easily accessible and easy to navigate by tech natives. Disclosure of self-injury behaviour may be facilitated by an online intervention. The evidence for self-injury specific treatment needs to be extended but prior to a large clinical trial, the feasibility of methods and procedures must be assessed. Trial registration: ClinicalTrials.Gov Identifier: NCT04243603

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