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The University of Southampton
Medicine

Ms Wendy O’Brien RN/MRes

Programme Grant Manager, Senior Research Sister MRes, Health and Safety representative PCPS (AHC)

Ms Wendy O’Brien's photo

Wendy is currently working as study manager for one of the UK’s largest clinical trials – HEAT, and has also recently become Programme manager for the REDUCE program of research in the Faculty of Medicine, University of Southampton.

Wendy is currently working as study manager for one of the UK’s largest clinical trials –HEAT, and has also recently become Programme manager for the REDUCE program of research. Previously Wendy was a practice nurse and began working the research field following a family relocation from North West London to the South Coast in 2007.

Wendy is a registered nurse with many years’ experience in Primary care. As a Senior Research sister and trial manager she has developed diverse skills both in project and people management.

In addition to these roles she also facilitates clinical supervision within a nursing team and is the departmental health and safety representative.

Qualifications

 Appointments held.

 

 

 

Research interests

Helicobacter Eradication Aspirin Trial (HEAT)

The problem (importance)

Aspirin has many therapeutic effects with one major drawback-its link to increased risk of bleeding. It is estimated that there are 25,000 inpatient referrals for gastric bleeds each year with the majority being in the over 60’s. These have been attributed to aspirin but in the presence of the bacterium Helicobacter pylori the risk increases by a further 10%. H. pylori is thought to be present in up to 50% of the population but the majority are asymptomatic and therefore would not be routinely tested. Conversely some experts think that H. pylori, like other bacteria living in our gut, may be good for us however, as yet no definitive advantage has been found.

Screening large numbers of over 60’s prescribed low dose aspirin for the bacterium will identify subjects who can be monitored periodically throughout the trial for subsequent incidence of gastric bleeds. The hypothesis is that by eradicating the bacterium there will be a reduction in gastric bleeding to improve quality of life whilst providing a monetary saving to the NHS.

The approach

The study is a large simple randomised controlled trial recruiting participants from general medical practices throughout England, Wales and Northern Ireland. Subjects are identified by the use of a bespoke web based trial management system, with the capability of running regular notes reviews of the consented participant records saving resources and providing timely data. Participants are invited to clinic to conduct a breath test to identify the presence of H. pylori. Positive subjects are randomised to a placebo or usual care triple eradication therapy as recommended in the BNF.

Findings (trustworthiness)

The study has consented over 19,513 participants to date revealing an 18% positive rate. Recruitment is planned to continue until August 2016 or until 87 endpoints (adjudicated hospital admissions for gastric bleeds) have occurred. The target recruitment is set at 33,000 consented participants. As yet, no adjudicated endpoints have been verified although potential cases are currently under review.

Consequences (significance)

Gastric bleeding continues to increase over time and therefore a suitable and cost effective solution needs to be identified. It is anticipated that the findings of this trial will show that eradicating H. pylori using a low cost therapy will result in a reduction of reported ulcer bleeds in the over 60’s taking a low daily dose of aspirin.

REDUCE

There is considerable concern about increasing antidepressant use in England. GPs are giving out more than 50 million prescriptions a year, to more than 1 in 10 adults.

Some people need long-term antidepressants to stop them getting depressed, but a third to a half could probably stop them without relapsing. However, stopping is not easy, due to withdrawal symptoms including anxiety and low mood which are usually temporary but feel similar to the reason why patients were first put on antidepressants. So understandably some people restart their antidepressant quickly. Others are reluctant to try stopping because they feel well on medication and are afraid their symptoms may come back.

People taking antidepressants have told us their GPs often do not review them and just give repeat prescriptions. Studies show that when GPs review patients on long-term antidepressants and advise them where appropriate to withdraw, only 1 in 14 is able to stop. Patients can be fearful and withdrawal can be tricky so GPs and Nurse Practitioners (NPs) who prescribe anti-depressants need to guide patients who want to withdraw, and patients need around the clock support. 

  • We aim to identify feasible, safe, reliable and cost-effective (value for money) ways of helping patients withdraw from long-term antidepressants, where this is appropriate.
  • We will first review all published relevant research, to identify successful ways to help patients withdraw from treatment.
  • We will identify the difficulties in withdrawing, and things that patients and practitioners think might help withdrawal, through interviews with patients taking antidepressants long-term, and through focus groups with GPs, NPs and primary care mental health workers (PCMHWs).
  • We will try out support through the Internet for patients, and their GPs, to help them.
  • An interactive programme will be developed to help support patient withdrawal from antidepressants, available around the clock.
  • It will be developed through a process of 'co-design' and 'coproduction' which means taking the views of patients and practitioners into account throughout its development and initial trial run.
  • We will also explore whether 'buddying' support from people who have come off antidepressants might help.
  • We will check the usefulness of the programme in helping patients stop treatment through a randomised controlled trial in three centres, and estimate financial benefits for the NHS.
  • If the programme works we will spread it throughout the NHS, by publishing practical guidance for professionals, and advice for patients to follow, publicised through patient support groups. 

We have developed the ideas for this project with the help of people having long-term treatment for depression. They will continue to work with us to help make sense of the information we gather, and advise on the support we develop for antidepressant withdrawal, from the patient’s point of view.

Please visit the Primary Care website.

Research group

Primary Care, Population Sciences and Medical Education

Research project(s)

HEAT Helicobacter Eradication Aspirin Trial

REDUCE (REviewing long term anti-Depressant Use by Careful monitoring in Everyday practice)

CERAbTc-19 (Clinical Evaluation of Rapid Antibody Test for Covid-19)

CERrnaTc-19 (Clinical Evaluation of Rapid RNA Test for Covid-19)

Wendy facilitates clinical supervision within a nursing team and is the departmental health and safety representative for Primary Care and Populations Sciences (Aldermoor Health Centre).

Ms Wendy O’Brien
Primary Medical Care and Population Sciences
Faculty of Medicine
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton SO16 5ST
Tel: 02380 591754
Fax: 02380 701125
Email: wob1u07@soton.ac.uk

Room Number : 9500 SGH/Southampton Clinical Trials Unit/S1

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