Protocol for a feasibility study to inform the development of a multicentre randomised controlled trial of asthma-tailored pulmonary rehabilitation versus usual care for individuals with severe asthma

Majd, Sally; Apps, Lindsay; Hudson, Nicky; Hewitt, Stacey; Eglinton, Elizabeth; Murphy, Anna; Bradding, Peter; Singh, Sally; Green, Ruth; Evans, Rachael A.

doi:10.1136/bmjopen-2015-010574

Cited by 7 publications

(1 citation statement)

References 50 publications

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“…Accordingly, approximately 25 participants will be recruited into each arm, giving a total sample size of 75 patients. Our sample size compares favourably to previous trials investigating treatment of idiopathic BPPV [47,48] and other feasibility studies [49,50]. We will use secondary outcome measures to inform a sample size calculation for a future RCT.…”

Section: Sample Sizementioning

confidence: 95%

A mixed methods randomised feasibility trial investigating the management of benign paroxysmal positional vertigo in acute traumatic brain injury

Smith

Marroney

Beattie

et al. 2020

Pilot Feasibility Stud

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Background Traumatic brain injury (TBI) is the leading cause of long-term disability in working age adults. Recent studies show that most acute TBI patients demonstrate vestibular features of dizziness and imbalance, often from combined peripheral and central vestibular dysfunction. Effective treatment for vestibular impairments post-TBI is important given its significant adverse impact upon quality of life and employment prospects. The most frequent peripheral vestibular disorder in acute TBI is benign paroxysmal positional vertigo (BPPV), affecting approximately half of acute cases. Although there is effective treatment for idiopathic BPPV, there are no high-quality clinical data for post-TBI BPPV regarding its prevalence, natural history, which treatment is most effective and when is the best time to treat. In particular, observational studies suggest post-TBI BPPV may be recurrent, indicating that hyperacute treatment of BPPV may be futile. Given the potential hurdles and the lack of accurate post-TBI BPPV data, the current study was designed to provide information regarding the feasibility and optimal design of future large-scale prospective treatment studies that would compare different interventions and their timing for post-TBI BPPV. Method A multi-centre randomised mixed methods feasibility study design was employed. We aim to recruit approximately 75 acute TBI patients across a range of clinical severities, from three major trauma centres in London. Patients will be randomised to one of three treatment arms: (1) therapist-led manoeuvres, (2) patient-led exercises and (3) advice. Participants will be re-assessed by blinded outcome assessors at 4 and 12 weeks. Acceptability of the intervention will be obtained by patient interviews at the end of their treatment and therapist interviews at the end of the study. Primary outcomes relate to feasibility parameters including recruitment and retention rates, adverse events and intervention fidelity. We will also aim to provide a more accurate estimate of the prevalence of BPPV in TBI cases on the trauma ward. Discussion The multi-centre nature of our feasibility study will inform the design of a future prospective treatment trial of BPPV in acute TBI. Important parameters we will obtain from this study, key for designing a future prospective treatment study, include estimating the prevalence of BPPV in TBI patients admitted to UK major trauma wards, and elucidating both patient and care-provider barriers in delivering BPPV treatment. Trial registration ISRCTN, ISRCTN91943864. Registered on 10 February 2020.

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Section: Sample Sizementioning

confidence: 95%

A mixed methods randomised feasibility trial investigating the management of benign paroxysmal positional vertigo in acute traumatic brain injury

Smith

Marroney

Beattie

et al. 2020

Pilot Feasibility Stud

View full text Add to dashboard Cite

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Pulmonary rehabilitation versus usual care for adults with asthma

Osadnik

Gleeson

McDonald

et al. 2022

Cochrane Database of Systematic Reviews

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Patient Perceptions of Living with Severe Asthma: Challenges to Effective Management

Apps

Chantrell

Majd

et al. 2019

The Journal of Allergy and Clinical Immunology: In Practice

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The funder had no role in the design of the study, data collection, analysis and interpretation or writing of the report and decision to submit for publication. Dr Rachael A Evans holds an NIHR clinical scientist 36 fellowship CS-2016-16-020. The views expressed in this article are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. Conflicts of interest We wish to confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this work that could 42 have influenced its outcome.

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Protocol for a feasibility study to inform the development of a multicentre randomised controlled trial of asthma-tailored pulmonary rehabilitation versus usual care for individuals with severe asthma

Cited by 7 publications

References 50 publications

A mixed methods randomised feasibility trial investigating the management of benign paroxysmal positional vertigo in acute traumatic brain injury

A mixed methods randomised feasibility trial investigating the management of benign paroxysmal positional vertigo in acute traumatic brain injury

Pulmonary rehabilitation versus usual care for adults with asthma

Patient Perceptions of Living with Severe Asthma: Challenges to Effective Management

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