Twenty four-hour helpline access to expert management advice for food-allergy-triggered anaphylaxis in infants, children and young people: a pragmatic, randomized controlled trial

Allergy ◽  
2013 ◽  
Vol 68 (12) ◽  
pp. 1598-1604 ◽  
Author(s):  
M. M. Kelleher ◽  
A. DunnGalvin ◽  
A. Sheikh ◽  
C. Cullinane ◽  
J. Fitzsimons ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Food Allergy ◽  
Young People ◽  
Controlled Trial ◽  
Children And Young People ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Management Advice

scholarly journals Therapist-Supported Online Interventions for Children and Young People With Tic Disorders: Lessons Learned From a Randomized Controlled Trial and Considerations for Future Practice (Preprint)

2020 ◽  
Author(s):  
Liam R Chamberlain ◽  
Charlotte L Hall ◽  
Per Andrén ◽  
E Bethan Davies ◽  
Joseph Kilgariff ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Clinical Care ◽  
Lessons Learned ◽  
Tic Disorders ◽  
Stepped Care ◽  
Behavioural Intervention ◽  
Children And Young People ◽  
Randomized Controlled

UNSTRUCTURED In recent years, research into internet-based cognitive behavioral therapy (iCBT) has suggested that therapist-guided digital interventions have greater engagement, adherence, and effectiveness than self-directed digital therapies. While research has focused on the effectiveness of, and adherence to, these interventions, less attention has been paid to their implementation in practice and what aspects of the therapist role support success. An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized. In light of the coronavirus disease 2019 (COVID-19) pandemic, there is greater emphasis on allowing patients access to remote therapies. We report the experiences and reflections of 4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention in a randomized controlled trial for children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial). Themes discussed include the importance of training, supervision, creating support documents/manuals, and record keeping. Alongside this are communication strategies used by therapists to encourage patient adherence and treatment effectiveness. These include rapport building, treatment personalization, and suggestions for overcoming non-engagement. These reflections offer important considerations for the delivery of iCBTs as well as implications associated with the implementation of these interventions in existing services and future research studies. We share thoughts on where iCBTs may sit in a stepped care model, how services may deal with comorbid conditions, and the potential role of iCBTs in collecting clinical data.

scholarly journals Protocol for the Process Evaluation of the Online Remote Behavioural Intervention for Tics (ORBIT) randomized controlled trial for children and young people

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
K. Khan ◽  
C. Hollis ◽  
C. L. Hall ◽  
E. B. Davies ◽  
D. Mataix-Cols ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young People ◽  
Process Evaluation ◽  
Qualitative Data ◽  
Controlled Trial ◽  
Clinical Care ◽  
Behavioural Intervention ◽  
Main Trial ◽  
Children And Young People ◽  
Randomized Controlled

Abstract Background Process evaluations are an important component in the interpretation and understanding of outcomes in trials. The Online Remote Behavioural Intervention for Tics (ORBIT) study is a randomized controlled trial evaluating the effectiveness of an Internet-delivered behavioural intervention (called BIP TIC) compared to an Internet-delivered education programme aimed at children and young people with tics. A process evaluation will be undertaken alongside the main trial to determine precisely how the behavioural intervention works and ascertain whether, and if so, how, the intervention could be successfully implemented in standard clinical practice. This protocol paper describes the rationale, aims, and methodology of the ORBIT trial process evaluation. Methods The process evaluation will have a mixed-methods design following the UK Medical Research Council 2015 guidelines, comprising both quantitative and qualitative data collection. This will include analysing data usage of participants in the intervention arm; purposively sampled, semi-structured interviews of parents and children, therapists and supervisors, and referring clinicians of the ORBIT trial, as well as analysis of qualitative comments put into the online therapy platform by participants at the end of treatment. Qualitative data will be analysed thematically. Quantitative and qualitative data will be integrated in a triangulation approach, to provide an understanding of how the intervention works, and what resources are needed for effective implementation, uptake and use in routine clinical care. Discussion This process evaluation will explore the experiences of participants, therapists and supervisors and referring clinicians of a complex online intervention. By contextualising trial efficacy results, this will help understand how and if the intervention worked and what may be required to sustain the implementation of the treatment long term. The findings will also aid in our understanding of factors that can affect the success of complex interventions. This will enable future researchers developing online behavioural interventions for children and young people with mental health and neurological disorders to gain invaluable information from this process evaluation. Trial registration International Standard Randomised Controlled Trials Number, ISRCTN70758207. Registered on 20 March 2018. ClinicalTrials.gov, NCT03483493. Registered on 30 March 2018.

scholarly journals Therapist-Supported Online Interventions for Children and Young People With Tic Disorders: Lessons Learned From a Randomized Controlled Trial and Considerations for Future Practice

10.2196/19600 ◽  
2020 ◽  
Vol 7 (10) ◽  
pp. e19600 ◽  
Author(s):  
Liam R Chamberlain ◽  
Charlotte L Hall ◽  
Per Andrén ◽  
E Bethan Davies ◽  
Joseph Kilgariff ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Clinical Care ◽  
Lessons Learned ◽  
Tic Disorders ◽  
Stepped Care ◽  
Behavioural Intervention ◽  
Children And Young People ◽  
Randomized Controlled

In recent years, research into internet-based cognitive behavioral therapy (iCBT) has suggested that therapist-guided digital interventions have greater engagement, adherence, and effectiveness than self-directed digital therapies. While research has focused on the effectiveness of, and adherence to, these interventions, less attention has been paid to their implementation in practice and what aspects of the therapist role support success. An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized. In light of the coronavirus disease 2019 (COVID-19) pandemic, there is greater emphasis on allowing patients access to remote therapies. We report the experiences and reflections of 4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention in a randomized controlled trial for children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial). Themes discussed include the importance of training, supervision, creating support documents/manuals, and record keeping. Alongside this are communication strategies used by therapists to encourage patient adherence and treatment effectiveness. These include rapport building, treatment personalization, and suggestions for overcoming non-engagement. These reflections offer important considerations for the delivery of iCBTs as well as implications associated with the implementation of these interventions in existing services and future research studies. We share thoughts on where iCBTs may sit in a stepped care model, how services may deal with comorbid conditions, and the potential role of iCBTs in collecting clinical data.

scholarly journals Impact of Xpert MTB/RIF on Antiretroviral Therapy-Associated Tuberculosis and Mortality: A Pragmatic Randomized Controlled Trial

2014 ◽  
Vol 1 (1) ◽  
Author(s):  
L. Mupfumi ◽  
B. Makamure ◽  
M. Chirehwa ◽  
T. Sagonda ◽  
S. Zinyowera ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Limited Resource ◽  
Hiv Treatment ◽  
Treatment Programs ◽  
Sputum Smear ◽  
Smear Microscopy ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Art Initiation

Abstract Introduction.  GeneXpert® MTB/RIF (Xpert) is now widely distributed in high human immunodeficiency virus (HIV)/tuberculosis (TB)-burden countries. Yet, whether the test improves patient-important outcomes within HIV treatment programs in limited resource settings is unknown. Methods.  To investigate whether use of Xpert for TB screening prior to initiation of antiretroviral treatment (ART) improves patient-important outcomes, in a pragmatic randomized controlled trial we assigned 424 patients to Xpert or fluorescence sputum smear microscopy (FM) at ART initiation. The primary endpoint was a composite of 3-month mortality and ART-associated TB. Results.  There was no difference in overall TB diagnosis at ART initiation (20% [n = 43] Xpert vs 21% [n = 45] FM; P = .80), with most patients in both groups treated empirically. There was no difference in time to TB treatment initiation {5 days (interquartile range [IQR], 3–13) vs 8 days [IQR, 3–23; P = .26]} or loss to follow-up (32 [15%] vs 38 [18%]; P = 0.38). Although a nonsignificant reduction in mortality occurred in the Xpert group (11 [6%] vs 17 [10%]; 95% CI, −9% to 2%; P = .19), there was no difference in the composite outcome (9% [n = 17] Xpert vs 12% [n = 21] FM; difference −3%; 95% CI, −9% to 4%). Conclusions.  Among HIV-infected initiating ART, centralized TB screening with Xpert did not reduce the rate of ART-associated TB and mortality, compared with fluorescence microscopy.

Sign in / Sign up

Export Citation Format

Share Document