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Study protocol: a multicentre, open-label, parallel-group, phase 2, randomised controlled trial of autologous macrophage therapy for liver cirrhosis (MATCH)

Por: Brennan · P. N. · MacMillan · M. · Manship · T. · Moroni · F. · Glover · A. · Graham · C. · Semple · S. · Morris · D. M. · Fraser · A. R. · Pass · C. · McGowan · N. W. A. · Turner · M. L. · Lachlan · N. · Dillon · J. F. · Campbell · J. D. M. · Fallowfield · J. A. · Forbes · S. J.
Introduction

Liver cirrhosis is a growing global healthcare challenge. Cirrhosis is characterised by severe liver fibrosis, organ dysfunction and complications related to portal hypertension. There are no licensed antifibrotic or proregenerative medicines and liver transplantation is a scarce resource. Hepatic macrophages can promote both liver fibrogenesis and fibrosis regression. The safety and feasibility of peripheral infusion of ex vivo matured autologous monocyte-derived macrophages in patients with compensated cirrhosis has been demonstrated.

Methods and analysis

The efficacy of autologous macrophage therapy, compared with standard medical care, will be investigated in a cohort of adult patients with compensated cirrhosis in a multicentre, open-label, parallel-group, phase 2, randomised controlled trial. The primary outcome is the change in Model for End-Stage Liver Disease score at 90 days. The trial will provide the first high-quality examination of the efficacy of autologous macrophage therapy in improving liver function, non-invasive fibrosis markers and other clinical outcomes in patients with compensated cirrhosis.

Ethics and dissemination

The trial will be conducted according to the ethical principles of the Declaration of Helsinki 2013 and has been approved by Scotland A Research Ethics Committee (reference 15/SS/0121), National Health Service Lothian Research and Development department and the Medicine and Health Care Regulatory Agency-UK. Final results will be presented in peer-reviewed journals and at relevant conferences.

Trial registration numbers

ISRCTN10368050 and EudraCT; reference 2015-000963-15

Feasibility of a multifaceted implementation intervention to improve attendance at diabetic retinopathy screening in primary care in Ireland: a cluster randomised pilot trial

Por: Riordan · F. · Murphy · A. · Dillon · C. · Browne · J. · Kearney · P. M. · Smith · S. M. · McHugh · S. M.
Objectives

Diabetic retinopathy screening (DRS) uptake is suboptimal in many countries with limited evidence available on interventions to enhance DRS uptake in primary care. We investigated the feasibility and preliminary effects of an intervention to improve uptake of Ireland’s national DRS programme, Diabetic RetinaScreen, among patients with type 1 or type 2 diabetes.

Design/setting

We conducted a cluster randomised pilot trial, embedded process evaluation and cost analysis in general practice, July 2019 to January 2020.

Participants

Eight practices participated in the trial. For the process evaluation, surveys were conducted with 25 staff at intervention practices. Interviews were conducted with nine staff at intervention practices, and 10 patients who received the intervention.

Interventions

The intervention comprised practice reimbursement, an audit of attendance, electronic prompts targeting professionals, General Practice-endorsed patient reminders and a patient information leaflet. Practices were randomly allocated to intervention (n=4) or wait-list control (n=4) (usual care).

Outcomes

Staff and patient interviews explored their perspectives on the intervention. Patient registration and attendance, including intention to attend, were measured at baseline and 6 months. Microcosting was used to estimate intervention delivery cost.

Results

The process evaluation identified that enablers of feasibility included practice culture and capacity to protect time, systems to organise care, and staff skills, and workarounds to improve intervention ‘fit’. At 6 months, 22/71 (31%) of baseline non-attenders in intervention practices subsequently attended screening compared with 15/87 (17%) in control practices. The total delivery cost across intervention practices (patients=363) was 2509, averaging 627 per practice and 6.91 per audited patient. Continuation criteria supported proceeding to a definitive trial.

Conclusions

The Improving Diabetes Eye screening Attendance intervention is feasible in primary care; however, consideration should be given to how best to facilitate local tailoring. A definitive trial of clinical and cost-effectiveness is required with preliminary results suggesting a positive effect on uptake.

Trial registration number

NCT03901898.

Is the outcome of fitting hearing aids to adults affected by whether an audiogram-based prescription formula is individually applied? A systematic review protocol

Por: Almufarrij · I. · Dillon · H. · Munro · K. J.
Introduction

Hearing aids are typically programmed using the individual’s audiometric thresholds. Developments in technology have resulted in a new category of direct-to-consumer devices, which are not programmed using the individual’s audiometric thresholds. This review aims to identify whether programming hearing aids using the individual’s audiogram-based prescription results in better outcomes for adults with hearing loss.

Methods and analysis

The methods of this review are reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. On 23 August 2020, eight different databases were systematically searched without any restrictions: EMBASE, MEDLINE, PubMed, PsycINFO, Web of Science, Cochrane Library, Emcare and Academic Search Premier. To ensure that this review includes the most recent evidence, the searches will be repeated at the final write-up stage. The population of interest of this review will be adults with any degree or type of hearing loss. The studies should compare hearing aids programmed using an audiogram-based prescription (and verified in the real ear) with those not programmed on the basis of the individual’s audiogram. The primary outcome of interest is consumers’ listening preferences. Hearing-specific health-related quality of life, self-reported listening ability, speech intelligibility of words and sentences in quiet and noisy situations, sound quality ratings and adverse events are the secondary outcomes of interest. Both randomised and non-randomised controlled trials will be included. The quality of each individual study and the overall evidence will be assessed using Downs and Black’s checklist and the Grading of Recommendations, Assessment, Development and Evaluations tool, respectively.

Ethics and dissemination

We will only retrieve and analyse data from published studies, so no ethical approval is required. The review findings will be published in a peer-reviewed journal and presented at scientific conferences.

PROSPERO registration number

CRD42020197232.

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