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Putting the patient at the centre: a call for research involvement of nurses, midwives and allied health professionals working in genomics

Por: Cowley · L. · Henriques · S. · Roberts · J. · Monje-Garcia · L. · Nolan · J. · Lubasch · K. · Theobald · R. · Greer · R. · Fennell · N. · Clarkson · A. · Clapham · M. · Chilton · S. · Allon · R. · Stopford · C. · Pierce · H. H. · Holliday · D.
Introduction

We report the collaborative views of a group of nurses, midwives and allied health professionals (NMAHPs) in the UK who have a genomics research remit or interest. Our group includes genetic counsellors under this diverse category of healthcare workers.

This group came together as part of the National Institute for Health and Social Care Research (NIHR) Genomics Research National Specialty Group. After responding to a survey to elicit the views of NMAHPs working in genomics, some of the original 45 respondents, along with others who learnt of the project by word of mouth, have worked together to produce this article.

Objective

The paper aims to set out in clear terms the value of NMAHPs to research that supports the patient-centred implementation of genomics in the National Health Service (NHS).

Key argument

We discuss four potential areas where NMAHPs, in particular, can contribute to the research. These are patient perspectives and epistemic justice, psychosocial impacts, the familial nature of genomics and equity. We argue that this group (NMAHPs) represents a potentially underused resource for the NHS as it seeks to ensure that advances in genomics are translated into patient benefit.

Conclusions

We propose that NMAHPs, with our research expertise, are well placed to shape and deliver a research agenda that explores models of patient-centred care in the genomics era. We call for increased funding for NMAHP research roles and funding opportunities to deliver this fundamental work.

Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial

Por: Pascart · T. · Fautrel · B. · Gottenberg · J.-E. · Ducoulombier · V. · Richez · C. · Truchetet · M.-E. · Avouac · J. · Morel · J. · Basch · A. · Cormier · G. · The SUNSTAR Study Group · The CRI-IMIDIATE Network · Houvenagel · E. · Mariette · X. · Norberciak · L. · Pascart · Ducoulom
Introduction

Biological disease modifying antirheumatic drugs (bDMARDs) have a central role in the treatment of rheumatoid arthritis (RA). Tumour necrosis factor inhibitors (TNFis) are commonly used as first-line agents, while non-TNFis (tocilizumab, abatacept and rituximab) have shown to be non-inferior to TNFis in head-to-head trials. In case of TNFi inadequate response, using other mechanisms of action provides a better response than using an alternate TNFi. Which non-TNFi bDMARD administered subcutaneously to allow for ambulatory management to choose in case of first line TNFi inadequate response has not been tested in a randomised clinical trial, while observational data support a potential superiority of tocilizumab over abatacept.

Methods and analysis

The SUNSTAR (SUbcutaNeouS Tocilizumab vs Abatacept in TNF Alpha inadequate responders for the treatment of Rheumatoid arthritis) study is a 52-week prospective, randomised, multicentre, open-label, superiority phase IV trial comparing subcutaneous tocilizumab with abatacept in a 1:1 ratio. Patients with active RA (Disease Activity Score-erythrocyte sedimentation rate >3.2 and Clinical Disease Activity Index (CDAI) >10) and with inadequate 3-month response to a first or second TNFi are included in 25 centres in France. The primary outcome is the CDAI improvement at week 24. Intention-to-treat analysis will be applied primarily. The secondary outcome is a composite outcome of the percentage of responders defined as a CDAI

Ethics and dissemination

Ethics approval was obtained from the committee for the protection of persons (Comité de protection des personnes Sud Méditerranée I 17.00608.001744). The findings from this study, whether positive or negative, will be published in peer-reviewed journals and will be presented at national and international conferences. The results will inform future recommendations on the management of RA.

Trial registration number

NCT03227419 and EudraCT2017-000947-41.

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