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The University of Southampton
Medicine

Ms Tammy Thomas FD, MPH (ongoing), PRINCE2® Foundation, PRINCE2® Practitioner (ongoing)

Trial Manager

Ms Tammy Thomas's photo

Tammy Thomas is a Trial Manager within Medicine at the University of Southampton.

As a research manager my primary role is to make sure the projects are delivered on time and to target, resulting in effective evidence to shape future practice.

Tammy joined the University of Southampton in 2002, starting as a clerical assistant in the School of Ocean and Earth Sciences at the then Southampton Oceanography Centre, providing support to the post and under graduate secretaries and an emeritus professor. In 2004 Tammy joined the team at PMC in trial administration and also worked for the WREN Research, Management and Governance Unit until 2008 when she began managing primary care studies.

Tammy graduated in Health and Social Care, University of Southampton in 2011, is working towards an MPH and is a harassment contact for the University’s Diversity team.

Tammy is currently managing an NIHR School of Primary Care Research funded feasibility pilot study, SNIFSII: Saline Nasal Irrigation For acute Sinusitis and is a Primary Care Trials Manager at the Southampton Clinical Trials Unit providing light touch support for primary care trials within the unit and those being led at PCPS.

 

 

 

Research interests

SNIFSII
Acute sinus infections are one of the commonest infections managed in primary care, Currently GPs prescribe antibiotics to most  patients presenting with sinusitis, the highest of any of the common acute infections presenting in adults, at over 90%.The trouble with prescribing for most people is that we are using antibiotics too much which is causing the bacteria to become resistant, which is likely to lead in the future to serious infections becoming untreatable from ‘superbugs’. Alternatives to the initial management with antibiotics are needed.

Previous studies have tried nasal irrigation using salt solution for colds but the studies are small and not conclusive. There have also been studies of nasal irrigation in chronic sinus infections which do show some benefit. A large study in chronic or recurrent sinusitis in primary care showed that most people can learn to do nasal irrigation with simple advice and a short video to show how it is done, find it acceptable and will keep doing it over several weeks. However, there was some evidence that the approach to help people use nasal irrigation could be made more effective, dealing with key barriers or difficulties more effectively. There have been no good studies of saline irrigation in acute sinusitis.

In a separate study, we have worked together with patients  to optimise how we help patients use sinus irrigation, making sure that we are providing all the necessary advice and materials to help deal with any issues or problems patients might have.  The study will randomise more than 100 people with acute sinus infections presenting in primary care to either a) immediate antibiotics (current usual treatment in primary care) or b) advice to do nasal irrigation for up to 3 weeks with a ‘back-up’ or delayed antibiotic prescription (a prescription that can be used if the sinusitis does not settle). Participants will fill out a daily symptom diary which will allow us to see whether irrigation makes any difference to symptom severity, or to the duration of illness, and whether antibiotic were used.

Participants who are happy to have further tests will have a swab of the nose.

This study will provide evidence of recruitment and follow-up rates, and is also likely to provide  preliminary evidence about whether antibiotic use is likely to be reduced, in order to provide sufficient evidence for a larger application for a full trial.

SCTU
Southampton Clinical Trial Unit (SCTU) designs, initiates, conducts and analyses high quality national and international clinical trials to directly influence routine clinical practice. In this role Tammy acts as the main point of contact for the relevant trial/s, additionally working with other trial managers to provide a ‘buddy’ system which ensures appropriate trial cover within SCTU. She takes responsibility for liaising with the Primary Care Group at Aldermoor Health Centre and the Senior Trial Manger within the SCTU to support the coordination of a number of Primary Care led NIHR Programme Grants.  This may include identifying sponsor specific processes and requirements, taking responsibility for writing and designing all trial documents including the protocol, and contributing to the development of the trial database.  Tammy identifies when protocol amendments become necessary and takes appropriate action in ensuring regulatory requirements are fulfilled and that all approvals and authorisations are secured, taking responsibility for applications as appropriate and assisting/advising participating investigators with local requirements.

2016 – CEDAR (Children’s Ear Pain) Study, University of Bristol, a paediatric individually randomised placebo controlled three-arm superiority trial with cost effective analysis, qualitative evaluation and a parallel observational cohort. The CEDAR trial supports the overarching goal of the UK’s Five Year Antimicrobial Resistance Strategy and Action Plan (2013 to 2018), and specifically its second strategic aim, to conserve and steward the effects of existing antibiotics by investigating if an antibiotic alternative (an anaesthetic ear drop) is effective in reducing reliance on, and consumption of, antibiotics.

2015 – ARCHIE Study, University of Oxford, a paediatric double-blind randomised placebo-controlled trial to determine whether treatment with a 5-day course of co-amoxiclav early during an influenza/ILI episode in at risk children reduces the likelihood of re-consultation due to clinical deterioration.

2014 – FAME Study, University of Southampton, A pilot study to inform a future study in the management of short-term (acute) fatigue.

2008 – SNIFS Study, University of Southampton, A primary care randomised controlled trial of nasal irrigation, steam inhalation and a combination of the treatments to ascertain effectiveness in the prevention of sinusitis symptoms.

2008 – TASTE Study, University of Southampton, A primary care randomised controlled trial of probiotics, xylitol and sorbitol for acute sore throat.

2008 – Internet Dr study, University of Southampton, A primary care trial of a tailored inter-active website for the self-management of respiratory infections.

2008 - SMILE Study, University of Southampton, A feasibility study to develop a preliminary version of a website to self measure and manage hypertension.

2007 – 2008 GRACE Study, (WP10a), University of Southampton, multi-national RCT to investigate the benefit of antibiotic in patients with LRTI in 13 EU networks.

2006 -2008 PRISM Study, University of Southampton, primary care streptococcal management and the use of rapid tests for sore throats

2004 – 2007 Unit Secretary/Coordinator, Research Management and Governance Unit

Research group

Primary Care & Population Sciences

Affiliate research group

Primary care Research group

Research project(s)

ALICE Antivirals for influenza like illness - an RCT of clinical and cost effectiveness in primary care

Infectious diseases are a major threat to human wellbeing and economic and social development. Influenza, a highly contagious virus, causes a common respiratory infection with local and systemic symptoms.

ARCHIE The early use of Antibiotics for at Risk CHildren with InfluEnza in primary care

CEDAR the children's ear pain study

FAME Fatigue: acute Fatigue Assessment and Management in Everyday practice

SNIFSII - Saline Nasal Irrigation For acute Sinusitis II

Acute sinus infections are one of the commonest infections managed in primary care, Currently GPs prescribe antibiotics to most  patients presenting with sinusitis, the highest of any of the common acute infections presenting in adults, at over 90%.

Oversight of SNIFSII coordinating centres; Universities of Oxford and Bristol

Network management & coordination

Trial set-up across Wessex

Coordination of Trial Steering Group and Data Monitoring and Ethics Committees

Monitoring adverse events

Ensuring trial quality

Overseeing manufacture & distribution of trial supplies

Ethical and CA approval

Monitoring and supervision of trial staff

Budget management

Reporting

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Ms Tammy Thomas
Primary Care and Population Sciences
University of Southampton
Faculty of Medicine
Aldermoor Health Centre
Aldermoor Close
Southampton SO16 5ST
T: 023 8059 1773
F: 023 8070 1125
E: tet@soton.ac.uk

Room Number: 9590 AHC/118/S2

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