The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial

IntroductionThe prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools.MethodA three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600 Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3–6 months and 9–12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact.Ethics and disseminationThis trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences.Trial registration numberISRCTN17631228.ProtocolV1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).

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Clinical and cost effectiveness of a parent mediated intervention to reduce challenging behaviour in pre-schoolers with moderate to severe intellectual disability (EPICC-ID) study protocol: a multi-centre, parallel-group randomised controlled trial

BMC Psychiatry ◽

10.1186/s12888-020-2451-6 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Olayinka Farris ◽

Rachel Royston ◽

Michael Absoud ◽

Gareth Ambler ◽

Jacqueline Barnes ◽

...

Keyword(s):

Intellectual Disability ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Challenging Behaviour ◽

Severe Intellectual Disability ◽

Parallel Group ◽

Randomised Controlled

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United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-017-2352-2 ◽

2017 ◽

Vol 18 (1) ◽

Cited By ~ 7

Author(s):

Stephen Brealey ◽

Alison L. Armstrong ◽

Andrew Brooksbank ◽

Andrew Jonathan Carr ◽

Charalambos P. Charalambous ◽

...

Keyword(s):

United Kingdom ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Secondary Care ◽

Controlled Trial ◽

Frozen Shoulder ◽

Arthroscopic Capsular Release ◽

Parallel Group ◽

Manipulation Under Anaesthesia ◽

Randomised Controlled

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Antimicrobial central venous catheters do not reduce infections in pre-term babies

BMJ ◽

10.1136/bmj.l4993 ◽

2019 ◽

pp. l4993

Author(s):

Rob Cook ◽

Duncan Fortescue-Webb ◽

Rosie Martin

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Health Technology ◽

Central Venous Catheters ◽

Central Venous ◽

Open Label ◽

Health Technology Assessment Programme ◽

Parallel Group ◽

Randomised Controlled ◽

Pragmatic Randomised Controlled Trial

The studyGilbert R, Brown M, Rainford N et al. Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial. Lancet Child Adolesc Health 2019;3:381-90.The study was funded by the NIHR Health Technology Assessment programme (project number 12/167/02).To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000782/antimicrobial-central-venous-catheters-for-pre-term-babies-do-not-reduce-infections

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Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

10.21203/rs.3.rs-210774/v1 ◽

2021 ◽

Author(s):

Jan Maláska ◽

Jan Stašek ◽

František Duška ◽

Martin Balík ◽

Jan Máca ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Primary Objective ◽

Efficacy And Safety ◽

Open Label ◽

Parallel Group ◽

Secondary Objective ◽

Randomised Controlled

Abstract ObjectivesThe primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days.

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An open-label, parallel-group, randomised controlled trial of antiseptic mouthwash versus antibiotics for oropharyngeal gonorrhoea treatment (OMEGA2)

Scientific Reports ◽

10.1038/s41598-020-76184-1 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Eric P. F. Chow ◽

Kate Maddaford ◽

Jane S. Hocking ◽

Catriona S. Bradshaw ◽

Rebecca Wigan ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Standard Treatment ◽

Controlled Trial ◽

Health Centre ◽

Nucleic Acid Amplification ◽

Open Label ◽

Parallel Group ◽

Randomised Controlled ◽

New Treatments ◽

Clinical Trials Registry

Abstract New treatments for oropharyngeal gonorrhoea are required to address rising antimicrobial resistance. We aimed to examine the efficacy of a 14-day course of mouthwash twice daily compared to standard treatment (antibiotic) for the treatment of oropharyngeal gonorrhoea. The OMEGA2 trial was a parallel-group and open-labelled randomised controlled trial among men with untreated oropharyngeal gonorrhoea that was conducted between September 2018 and February 2020 at Melbourne Sexual Health Centre in Australia. Men were randomised to the intervention (rinsing, gargling and spraying mouthwash twice daily for 14 days) or control (standard treatment) arm and followed for 28 days. Participants in both arms were advised to abstain from sex and kissing with anyone for 14 days after enrolment. Oropharyngeal swabs were collected at baseline, Day 14 and Day 28 and tested for Neisseria gonorrhoeae by nucleic acid amplification test (NAAT) and culture. The primary outcome was the detection of oropharyngeal N. gonorrhoeae by NAAT at Day 14 after treatment. This trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12618001380280). This trial stopped early due to a high failure rate in the mouthwash arm. Twelve men were randomly assigned to either mouthwash (n = 6) or standard treatment (n = 6). Of the 11 men who returned at Day 14, the cure rate for oropharyngeal gonorrhoea in the mouthwash arm was 20% (95% CI 1–72%; 1/5) and in the standard treatment arm was 100% (95% CI 54–100%; 6/6). A 14-day course of mouthwash failed to cure a high proportion of oropharyngeal gonorrhoea cases.

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