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 Multicentre endoscopist-blinded randomised clinical trial to compare two bowel preparations after a colonoscopy with inadequate cleansing: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029573
Author(s):  
Michael Sai Lai Sey ◽  
Daniel von Renteln ◽  
Richard Sultanian ◽  
Cassandra McDonald ◽  
Myriam Martel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bowel Preparation ◽  
Task Force ◽  
Good Clinical Practice ◽  
Randomised Clinical Trial ◽  
Phase Iii ◽  
Clear Fluid ◽  
Split Dose ◽  
Bowel Preparations ◽  
Colonoscopy Quality

IntroductionInadequate bowel preparation is common and negatively impacts colonoscopy quality. The objective of this study is to compare two bowel preparation regimens in cleansing the colon after an index colonoscopy with failed bowel preparation.Methods and analysisThis is a phase III, multicentre, randomised clinical trial comparing two bowel preparation regimens after failure to adequately cleanse at the index colonoscopy. Regimen A consists of 4 L split-dose polyethylene glycol electrolyte solution (PEG-ELS) and Regimen B consists of 6 L split-dose PEG-ELS, both preceded by 15 mg of bisacodyl the day before the procedure along with a low-fibre diet 3 and 2 days before the procedure followed by a clear fluid diet starting the day before the procedure. The primary outcome is adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score of ≥6 with each segment score ≥2. Secondary outcomes include mean BBPS score, bowel preparation adequacy using the US Multi-Society Task Force on Colorectal Cancer definition, detection rate by polyp subtype, caecal intubation rate, mean Validated Patient Tolerability Questionnaire for Bowel Preparation score, subject willingness to repeat the preparation and faecal incontinence rate.Ethics and disseminationThe study will be conducted in accordance with Good Clinical Practice guidelines and local institutional standards. Study findings will be disseminated at an international gastroenterology conference and published in peer-reviewed journals.Trial registration numberNCT02976805; Pre-results.

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

scholarly journals An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Markus Harboe Olsen ◽  
Britt Morthorst ◽  
Anne Katrine Pagsberg ◽  
Michella Heinrichsen ◽  
Bo Møhl ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emotion Regulation ◽  
Statistical Analysis ◽  
Randomised Clinical Trial ◽  
Statistical Analysis Plan ◽  
Feasibility Trial ◽  
Treatment As Usual ◽  
Link Type ◽  
Self Injury ◽  
Statistical Report

Abstract Background Non-suicidal self-injury (NSSI) has a lifetime prevalence of 17% in adolescents in the general population and up to 74% in adolescents with psychiatric disorders. NSSI is one of the most important predictors of later suicidal behaviour and death by suicide. The TEENS feasibility trial was initiated to assess the feasibility and safety of Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as an add-on to treatment as usual in 13–17-year-old patients with NSSI referred to the Child and Adolescent Mental Health Services. Methods The TEENS feasibility trial is a randomised clinical trial with a parallel-group design. The trial intervention is an 11-week online therapy which is tested as an add-on to treatment as usual versus treatment as usual. The primary feasibility outcomes are the fraction of participants who (1) completed 12 weeks of follow-up interview or assessment, (2) consented to inclusion and randomisation out of all eligible participants, and (3) were compliant with the experimental intervention, assessed as completion of at least six out of eleven modules in the programme. Since this is a feasibility trial, we did not predefine a required sample size. The exploratory clinical outcome, the frequency of NSSI episodes, assessed using Deliberate Self-Harm Inventory – Youth version (DSHI-Y), at the end of intervention, is planned to be the future primary outcome in a larger pragmatic definitive randomised clinical trial. After completion of the feasibility trial, blinded data will be analysed by two independent statisticians blinded to the intervention, where ‘A’ and ‘B’ refer to the two groups. A third party will compare these reports, and discrepancies will be discussed. The statistical report with the analyses chosen for the manuscript is being tracked using a version control system, and both statistical reports will be published as a supplementary material. Based on the final statistical report, two blinded conclusions will be drawn by the steering group. Discussion We present a pre-defined statistical analysis plan for the TEENS feasibility trial, which limits bias, p-hacking, data-driven interpretations. This statistical analysis plan is accompanied by a pre-programmed version-controlled statistical report with simulated data, which increases transparency and reproducibility. Trial registration ClinicalTrials.govNCT04243603. Registered on 28 January 2020

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 A prospective randomised controlled clinical trial to evaluate three immobilisation devices for intra-thoracic radiation therapy

2010 ◽  
Vol 9 (2) ◽  
pp. 65-75 ◽  
Author(s):  
Evelyn O'Shea ◽  
John Armstrong ◽  
Charles Gillham ◽  
Roisin McCloy ◽  
Rachel Murrells ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Systematic Errors ◽  
Patient Comfort ◽  
Controlled Clinical Trial ◽  
Random Errors ◽  
Thoracic Radiation ◽  
Randomised Controlled Clinical Trial ◽  
Set Up ◽  
Randomised Controlled ◽  
Lung Radiotherapy

AbstractPurpose: To determine the optimal of three immobilisation devices for lung radiotherapy in terms of set-up reproducibility, patient comfort, radiation therapists’ (RTs) satisfaction and cost-effectiveness.Materials and methods: A total of 30 lung CRT patients were randomised to one of three immobilisation techniques – Arm A, headsponge; Arm B, BreastBoard dedicated immobilisation device; and Arm C, LungBoard dedicated immobilisation device.Results: Random errors were larger for Arm A versus C in all directions (p < 0.05). Random errors were larger for Arm A versus B for y and z directions (p < 0.05). When the data for the immobilisation devices (Arms B+C) were pooled and compared with Arm A (no dedicated device), the systematic errors were larger in the z direction for A (p < 0.05). Arm C was cheaper and was more comfortable for patients. Therapists preferred this device (Arm C) and treatment times were less (p < 0.05).Conclusion: This is the first prospective randomised controlled lung immobilisation trial, based on 3-DCRT, that takes into account treatment accuracy, users satisfaction and resource implications. It suggests that the LungBoard immobilisation device is optimal.

scholarly journals An internet-based emotion regulation intervention versus no intervention for nonsuicidal self-injury in adolescents: study protocol for a feasibility trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Britt Morthorst ◽  
Lotte Rubæk ◽  
Jane Lindschou ◽  
Janus Christian Jakobsen ◽  
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. 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.

scholarly journals An internet-based emotion regulation intervention versus no intervention for nonsuicidal self-injury in adolescents: study protocol for a feasibility trial

2021 ◽  
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. 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

scholarly journals T46. THE EFFECT OF COMPREHENSIVE COGNITIVE REMEDIATION IN INDIVIDUALS AT ULTRA-HIGH RISK FOR PSYCHOSIS: A SINGLE-BLIND, RANDOMISED, CLINICAL TRIAL (FOCUS)

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S249-S249
Author(s):  
Louise Birkedal Glenthoej ◽  
Mariegaard Lise ◽  
Birgitte Fagerlund ◽  
Jens Richardt Jepsen ◽  
Tina Dam Kristensen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Social Cognitive ◽  
Intervention Group ◽  
Cognitive Remediation ◽  
Randomised Clinical Trial ◽  
Treatment As Usual ◽  
Ultra High Risk ◽  
Social Cognitive Remediation

Abstract Background Individuals at ultra-high risk (UHR) for psychosis display significant cognitive deficits that constitute a barrier to functional recovery. Applying cognitive remediation (CR) before the onset of manifest psychosis may improve cognition and the clinical and functional prognosis of UHR individuals. Methods This randomised, clinical trial randomly assigned 146 UHR individuals aged 18–40 years to treatment as usual (TAU) or TAU plus cognitive remediation. The cognitive remediation consisted of 20-weeks of neurocognitive and social cognitive remediation. Assessments were carried out at 6- and 12-months post baseline. Primary outcome was composite score on the Brief Assessment of Cognition in Schizophrenia (BACS) battery at 6-months. Results Between April 2014 and January 2017, 73 UHR individuals were assigned to TAU and 73 were assigned to TAU + cognitive remediation. Compared to the control group, cognitive remediation did not result in significant improvement on the BACS composite score at 6-month follow-up (b=-0.125, 95%CI: -0.23 to 0.172, p=0.41). Nor did the intervention improve secondary outcomes in clinical symptoms or functioning. Exploratory analyses found emotion recognition latencies to be significantly more reduced in the intervention group than the TAU group at 6-months follow-up. At 12-month follow-up the intervention group exhibited significantly better performance on two exploratory outcomes of executive function and visual memory. The participants in the intervention group attended an average of 12 sessions out of 20. No adverse events were reported relating to the intervention. Discussion While the brief course of treatment did not impact global cognition, symptoms and functioning measures, treatment related benefit was found in exploratory component neuro- and social cognitive measures. Future studies should evaluate whether more personalized interventions such as the separate application of neurocognitive and social cognitive remediation may produce beneficial effect on cognition and functioning compared to treatment as usual, along with establishing the optimal number of training hours to produce cognitive and functional gains.

Statistics and parallaxes

1978 ◽  
Vol 48 ◽  
pp. 7-29
Author(s):  
T. E. Lutz
Keyword(s):  
Experimental Design ◽  
Statistical Methods ◽  
Review Paper ◽  
Systematic Errors ◽  
Past Experience ◽  
Random Errors ◽  
Trigonometric Parallaxes ◽  
Systematic And Random Errors

This review paper deals with the use of statistical methods to evaluate systematic and random errors associated with trigonometric parallaxes. First, systematic errors which arise when using trigonometric parallaxes to calibrate luminosity systems are discussed. Next, determination of the external errors of parallax measurement are reviewed. Observatory corrections are discussed. Schilt’s point, that as the causes of these systematic differences between observatories are not known the computed corrections can not be applied appropriately, is emphasized. However, modern parallax work is sufficiently accurate that it is necessary to determine observatory corrections if full use is to be made of the potential precision of the data. To this end, it is suggested that a prior experimental design is required. Past experience has shown that accidental overlap of observing programs will not suffice to determine observatory corrections which are meaningful.

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