The Royal Wolverhampton NHS Trust Trust Board Report Meeting Date:

26th September 2016

Executive Summary:

R&D Directorate Report - Research undertaken across Trust This report provides an overview of the research currently underway at RWT, including details of Trust sponsored research activity.

Action Requested:

To receive the report for information.

Report of:

Research & Development Director

Author:

Dr J Cotton, R&D Director

Title:

Contact Details:

Tel 01902 694218

Email [email protected]

Resource Implications:

Finance, workforce, time, facilities

Public or Private:

Public Session

(with reasons if private)

References:

Nil

(eg from/to other committees)

Appendices/

1. Clinical Specialty Research Activity

References/

2. Trust sponsored research.

Background Reading NHS Constitution: (How it impacts on any decision-making)

In determining this matter, the Board should have regard to the Core principles contained in the Constitution of: Equality of treatment and access to services High standards of excellence and professionalism Service user preferences Cross community working Best Value Accountability through local influence and scrutiny

Background Details 1

Overview RWT is a research active organisation undertaking studies across a range of clinical specialties and this includes both studies hosted by the Trust and ‘home grown’ Trust sponsored research. The availability of research for patients provides a number of complementary additions to existing health care, treatment and choice.

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Feedback from research participants confirms that they value the opportunity to take part in research and that they feel supported and cared for when doing so. The R&D Directorate we are currently collating information on Trust publications and will submit this to the next meeting of the Trust Board.

2.

Overall research activity As at end August 2016, there were 283 research projects at RWT where participants were either being actively recruited into a study, or the study was closed to new recruits but participants were being follow-up as part of the project protocol. The Trust takes part in a variety of studies across a wide range of clinical specialties. This includes adopted commercial and non-commercial projects (NIHR Portfolio adopted and non-portfolio) and studies being undertaken purely as part of academic courses. A summary is given below, whilst a breakdown of study type across the specialties is given in Appendix 1. 2%

6%

2%

Commercial Portfolio

27%

Non-Commercial Portfolio Commercial Non-Portfolio Non-Commercial Non-Portfolio Academic/Student

63%

Participants are being consented at RWT into 255 of the above studies. In the remaining 28 projects, RWT is identifying suitable patients and referring them to another recruiting site or is undertaking the continuing care of a patient who has been consented into a study at another healthcare organisation.

3

Study Classification NIHR Portfolio studies are grouped according to their methodology. There is a correlation between a study’s band and its complexity, with Band 3 studies tending to be complex, interventional trials. The below chart shows that a high

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proportion of open trials at RWT which are currently recruiting patients are Band 3, indicating the Trusts success in attracting and delivering this type of study. 5% 25%

Band 1 29%

Band 2 Band 3 Unbanded (Commercial)

41%

Band 1: Any study with a UK sample size of 10,000 or more Band 2: Observational studies with a UK sample size of less than 10,000 Band 3: Interventional studies with a UK sample size of less than 10,000

4

Trust sponsored Research RWT is currently sponsoring 16 ‘own account’ studies, with a number currently undergoing Peer Review prior to submission for Health Research Authority and Ethics approval. Two of these studies, both within the Cardiovascular service, are classed as CTIMPs (Clinical Trial of Investigational Medicinal Products) and require a high level of monitoring to ensure adherence with European and UK regulator standards. This quality assurance role is undertaken by the R&D Directorate. A full list of active ‘own account’ studies, along with their specialty, study type and name of the Chief Investigator is given in Appendix 2

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Appendix 1 – Clinical Specialty Research Activity Clinical Specialty

Study Type Portfolio Commercial

All Diseases Audiology Blood Cancer Cardiovascular Critical Care Dementia Dermatology Diabetes Gastroenterology Generic Healthcare Infectious Diseases Metabolic/Endocrine Musculoskeletal Neurology Obstetrics & Gynae Ophthalmology Paediatrics Renal Respiratory Stroke Surgery Total

31 6

2 5 10

13

5 1 1 2 1 77

Portfolio NonCommercial 1 1 50 10 3 1 4 3 15 3 2 1 15 2 14 6 15 12 8 9 2 177

Non Portfolio Commercial

Non Portfolio Non-Commercial 1

1 2 1

1 4 1

Student / Academic

1 1

1

1

2 2 3

1 1 1 1

1 16

1 7

1

6

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Appendix 2 - Trust Sponsored Research Speciality Cardiology

Project Name The Effect of Intravenous Cangrelor and Oral Ticagrelor on Platelets, the Microcirculation and Myocardial Damage in Patients admitted with STEMI Treated by Primary Percutaneous Coronary Intervention: A randomized controlled pilot trial.

Study Type

Chief Investigator

Current Status

CTIMP

Prof J Cotton

Active

CTIMP

Mr Luckraz

In Follow-up

The impact of genetic polymorphisms on coronary and lower limb collateral vessel development in patients presenting with unstable coronary disease and lower limb ischaemia

Non-CTIMP

Vince Amoah

In Follow-up

The effect of the systemic inflammatory response, as provoked by elective orthopaedic surgery, on circulating glycaemic markers

Non-CTIMP

Prof Gamma

In Follow-up

The Impact of Children’s Eczema on Parents’ Quality of Life

Non-CTIMP

Dr Al-Abadie

Active

The Psychosocial Impact of Rosacea on Patients Quality of Life:

Non-CTIMP

Dr Al-Abadie

Active

The association between obesity, metabolic syndrome and hepatobiliary and gall bladder cancer: a nested cohort study

Non-CTIMP

Dr S Menon

Active

Develop & pilot a model of self management after bowel cancer

Non-CTIMP

Nicola Payton

In Follow-up

Can Intravenous Iron Reduce Transfusion rates in Anaemic patients undergoing Cardiac Surgery (CIRTACS)

Clinical Chemistry

Dermatology

Gastroenterology

Oncology

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Ophthalmology

Renal

Surgery

Corporate

Strategies for preserving good vision in the second eyes of patients who have had irriversable vision loss from macular degeneration in their first eyes - delivery and outcome of second eye screening system.

Non-CTIMP

Mrs N Narendren

Active

In vivo confocal microscopy & histopathology of the ocular surface

Non-CTIMP

Dr V Hu

In Follow-up

Metabolomics in AMD: The role of metabolomics in age related macular degeneration

Non-CTIMP

Prof Yit Yang

In Follow-up

Serological analysis of endogenous virus HERV -K10 in renal lupus.

Non-CTIMP

Dr P Rylance

Active

The Detection and Quantification of Human Endogenous Retrovirus (HERV's) and Investigations of associated Antibodily Reactivity in Rheumatological Disease

Non-CTIMP

Dr P Rylance

Active

Non-CTIMP (Device Study)

Mrs R Vidya

Active

Intra-operative monitoring of the external branch of the superior laryngeal nerve (EBSLN) during thyroid surgery: does it improve voice preservation?

Non-CTIMP

Miss P Baruah

Active

Caught in the middle: Hearing the voices of governance officers in an NHS Trust

Non-CTIMP

TJ Ahme

Active

Sentimag along with routine technique in detection of Sentinel Node Biopsy.

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