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NHS Leeds West CCG

Research Service Annual Report 2014-2015

Author: Erica Warren, Head of Research

Date: June 2015

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Contents

Page

Foreword 2

Executive Summary 4

Background 5

Research Governance 8

Research Development and Management 13

Research Engagement 22

Knowledge Transfer 27

Glossary 29

Appendices

Appendix One – The research team 33

Appendix Two – Study summaries 40

Appendix Three – ARC forum report 56

Appendix Four - Understanding prescribing of opioids for chronic 71 non-cancer pain in general practice

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Foreword

Throughout 2014/15 the Research Service within Yorkshire and Humber Commissioning Support has continued

to support NHS Leeds West Clinical Commissioning Group (CCG) to fulfil its statutory responsibilities in relation

to research, as outlined in the 2012 Health and Social Care Act.

This last year has seen research in the NHS be given more of a focus and its importance reflected in further key

policy and guidance updates. In April 2014, for the first time NHS England included research in the 2014/15

"standard contract" they provide NHS organisations for use when commissioning services. Research has also

been included in planning guidance issued by NHS England to Providers and Commissioners to ensure they

understand the importance of research to delivering high quality care. These are two great steps that have

really helped embed research as a core priority for the NHS.

The annual report highlights that we are achieving all of the national research governance metrics in relation

to research, and in fact they are being exceeded in Leeds West. As part of the National Institute for Health

Research (NIHR) Research Support Services (RSS) framework for local health research management we are

measured against a local process target of 15 days to grant NHS permission for 80% of all valid applications.

Currently the median number of days for NHS Leeds West CCG is 9.5 days for 100% of all applications to the

CCG, well within the process target.

Significant national reorganisation of the NIHR Clinical Research Network (CRN) in 2014/15 has seen fewer

research studies being offered, and this is reflected in the proportion of practices actively offering patients the

opportunity to take part in research by recruiting them to studies. In 2013/14 NHS Leeds West CCG had over

70% of practices actively recruiting patients, but this year this has dropped to just over 51%. That said; this still

far exceeds the NIHR Clinical Research Network (CRN) primary care speciality specific target of 5% for the

proportion of GP sites within an individual CCG being research capable.

An NIHR CRN overarching objective is that 25% of general medical practices will recruit to NIHR Portfolio

Studies. In 2014/15 West Yorkshire as a region achieved 37.6% and NHS Leeds West CCG has made an

important contribution to this.

It is also important to note that 57% of NHS Leeds West CCG member practices are participating in the ASPIRE

study. So although some practices are not recruiting patients into research they are participating by

contributing anonymised data which will actively contribute to improved patient care and outcomes in the

future.

Making research real for commissioners is also a key goal of the service and in listening to the needs of

commissioners, the research team, working in collaboration with our Academic Health Science Network

(AHSN) and University partners, have established a pioneering new way to bring academia and the NHS

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together, via our ARC forums (Applying Research in Commissioning Decisions), to support evidence-based

commissioning.

This annual report reflects the commitment of the Research Service to provide excellent quality support to

NHS Leeds West CCG, working in collaboration with the CCG to promote and conduct research for the health

and wellbeing of local patients and the public.

Erica Warren

Head of Research and Health Economics, Evidence and Evaluation Services

Yorkshire and Humber Commissioning Support

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Executive Summary In England, the NHS constitution confirms research as a core function of the NHS which reaffirms the

commitment of the NHS, throughout the UK, to promote and conduct research to improve health and social

wellbeing and to improve NHS patient care services. The Health and Social Care Act 2012 also reaffirms this

through the powers and duty it places on the Secretary of State and others to support and promote research.

In April 2014 the NHS entered its second year as realigned in the Health and Social Care Act 2012. For the first

time NHS England included research in the 2014/15 "standard contract" they provide NHS organisations for

use when commissioning services. Research has also been included in planning guidance issued by NHS

England to Providers and Commissioners to ensure they understand the importance of research to delivering

high quality care. These are two great steps that have really helped embed research as a core priority for the

NHS.

This report provides a description of the work that the Yorkshire and Humber Commissioning Support (YHCS)

Research Team has undertaken in delivering a comprehensive research service on behalf of and in

collaboration with NHS Leeds West Clinical Commissioning Group (CCG) to ensure that the CCG has met its

statutory obligations with regards to research.

The key headlines are:

16 new studies were granted NHS assurance by the YHCS research team on behalf of NHS Leeds West

CCG.

Currently the median number of days for granting NHS assurance on behalf of NHS Leeds West CCG is

9.5 days for 100% of all studies; the NIHR CRN local process target is 15 days for 80% of all valid

applications to the CCG, so the CCG is well within the process target.

57% of NHS Leeds West CCG member practices are participating in research by contributing

anonymised patient data as part of the Action to Support Practices Implementing Research Evidence

(ASPIRE) study

Significant national reorganisation of the NIHR Clinical Research Network (CRN) in 2014/15 has seen

fewer research studies being offered, however, 51% of practices within NHS Leeds West CCG are

actively offering patients the opportunity to take part in research by recruiting them to studies well

above the CRN performance and operating framework 2014-15 primary care speciality specific target

of 5% for the proportion of GP sites within any individual CCG as research capable.

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Background The purpose of this paper is to provide an update on the research service provided by YHCS to NHS Leeds West

CCG. This report summarises the last 12 months from 1st April 2014 to 31st March 2015.

The team at YHCS ensures all the research activity which is led, hosted or carried out within the West Yorkshire

CCGs and their member practices is undertaken in accordance with current governance and regulatory

requirements, ultimately ensuring the safety and quality of care of our patients. (Please refer to appendix one

for team biographies). This service operates in four core areas:

Research Governance

YHCS will act as a signatory for permission for research activity and will provide:

A letter of permission to the researcher outlining that they can now engage with individual General

practices to carry out research activity

Process the Research Passport (if required) by the members of the research team

Issue a Letter of Access (if required) to the members of the research team

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However in following circumstances:

Where there is an Excess treatment Cost Associated with the Research

Where the Principle Investigator is a member of staff within the CCG

Where the participants are members of staff within the CCG

YHCS will not provide permissions until authorisation has been given in writing by the CCG.

Whilst acting on behalf of the General practices within a CCG YHCS will, as part of its core offer:

Work with researchers/potential applicants for research governance approval to support them

through the local/site specific elements of the applications process

Process applications for research governance permission in line with current CSP/RDMIS requirements

Ensure all necessary documentation is available to facilitate the permission process

Ensure comprehensive risk assessment is undertaken on all applications for approval, which consider:

­ Science

­ Information

­ Finance

­ Ethics

­ Health and Safety

Ensure all research activity complies with the Research Support Services (RSS) framework as advocated

by the Department of Health (DoH) and the National Institute for Health Research (NIHR)

Ensure all applications are processed within the required timescales and local Yorkshire and Humber

Clinical Research Network (YH CRN) metrics are achieved throughout

Act as ‘first point of contact’ for all Excess Treatment Cost (ETC) funding requests

Research Management and Development

The team provides support and involvement in a number of externally funded research grants, acting

as the lead NHS organisation

We provide regular reports to the Department of Health (as required) regarding progress with projects

We work closely with the Chief Investigators and project management teams to ensure timely

completion of the project, within budget

We act as ‘first point of contact’ for all external research partners/stakeholders

We work closely with the NIHR CRN Division 5

We ensure each of the services/functions outlined above are managed in accordance with NHS

standing financial instructions and the relevant governance and regulatory frameworks

We manage and administer the Research Capability Fund process on behalf of the CCGs in West

Yorkshire

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We work closely with the CCGs on research grant applications, especially where the CCG will act as the

NHS host organisation

Research Engagement

We maintain regular contact with the CCGs

We make CCGs aware of all relevant obligations regarding research activity

We work with CCGs to ensure research is promoted throughout its region

We hold regular research network meetings with the GPs

We attend where necessary clinical governance meetings to report on research activity

We provide at least an annual report detailing NIHR and non NIHR activity, consistent with reports

provided from research networks, both comprehensive and topic specific

We ensure appropriate representation at strategic and operational meetings for each of the

functions/service outlined above, for example:

­ YH CRN Board/Executive (as required)

­ Bradford Institute for Health Research (BIHR)

­ Collaborations for Leadership in Applied Health Research (CLAHRC)

­ Academic Health Science Network (AHSN)

­ West Yorkshire R&D Managers Group

­ R&D Forum

(This is not an exhaustive list as new vehicles for dissemination / promotion are evolving, e.g. the use of social

media)

Knowledge Transfer

We facilitate dissemination through research network meetings

We provide evidence and expert support to the projects and programmes transformation team

We share live learning, acting as a conduit for evidence learned between projects throughout YHCS

We contribute to evidence briefings and reports

We provide CCGs with six monthly updates on recent research activity

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Research Governance

Research assurance – NHS Permission

In total throughout 2014/15 YHCS has provided NHS permission for 16 studies on behalf of Leeds West CCG.

We have highlighted the seemingly low level of studies received into the region to the NIHR Clinical Research

Network (CRN) who have informed us that this current level is a reflection of the lower number of studies

coming through nationally. The CRN feels this is inherently linked to the network re-organisation and it is

anticipated this will change and increase over the coming months.

Figure 1 shows NHS Permissions issued by YHCS on behalf of Leeds West CCG, broken down by month, from

1st April 2014 to 31st March 2015.

Figure 1. NHS assurance (permissions) issued

Table 1. List of studies

April

1. Early evaluation of the Integrated Care and Support Pioneers 2. GP referral patterns for patients with hearing loss 3. How Does Current PPI Affect Delivery of Primary Care

May

4. FADES - Feeding and Autoimmunity in Down's syndrome Evaluation Study

June

5. CADIAS - Cancer Diagnosis In the Acute Setting

September

6. DSRU Fluenz - Flu vaccine study

October

7. INSTinCTS 8. Comparing Simulation to Traditional Teaching in Gout Management

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November

9. Leeds Osteoarthritis Hip Cohort 10. The personalised feedback model

January

11. Eurythdia (PIC) (Chronotherapeutic lifestyle intervention for diabetes) 12. Gonorrhoea: to screen or not to screen 13. Action to support practices implementing research evidence – ASPIRE

March

14. Dementia caregivers' access of information resources (PIC) 15. eCRT2 study (Electronic intervention to reduce antibiotic prescribing) 16. Brexpiprazole in patients with major depressive disorder (PIC)

The Department of Health and the NIHR want to make research start up faster and its delivery easier for Chief

Investigators in the NHS. The NIHR approach is to make NHS providers’ performance in starting and delivering

research transparent and accountable, through changes to new NIHR contracts, which include a 70 day

benchmark from submission of valid application to initiation of research.

As part of the NIHR Research Support Services (RSS) framework for local health research management we are

measured against a local process target of 15 days to grant NHS permission for 80% of all studies. Currently

the median number of days for Leeds West CCG is 9.5 days for 100% of all studies, well within the process

target.

Health Research Authority (HRA) News

HRA Approval is the new approval that will be required for research to commence in the NHS in England. It is a

new process that comprises a review by a Research Ethics Committee as well as an assessment of regulatory

compliance and related matters undertaken by dedicated HRA staff. HRA Approval will support and

complement local processes relating to assessing, arranging and confirming local capacity and capability to

undertake the study.

The phased roll out of HRA Approval will begin on 11th May 2015 for certain types of health services research.

The first cohort of studies is restricted to research recruiting only NHS staff that does not require review by a

NHS Research Ethics Committee.

As part of HRA assessment studies for the first phase of implementation will be assessed against the following

areas:

Compliance and delivery

Contract assurance

Investigator suitability

The YHCS team will keep the CCG informed of progress of the changes as they happen and will consult with the

CCG should there be potential impact outside of ‘business as usual’ in terms of research activity.

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Research monitoring arrangements

Monitoring is the act of overseeing the progress of a research study, and of ensuring that it is conducted,

recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical

Practice (GCP), and the applicable regulatory requirement(s). YHCS completes a risk assessment for every

study and a monitoring plan is put in place accordingly to the level of risk the study poses. To date there are no

significant issues to report.

Research Amendments

All amendments to former PCT and recently approved primary care studies across Yorkshire and Humber CCGs

are notified to YHCS.

A revised UK study amendment handling process was introduced across the UK in November 2014. The

purpose is to reduce the number of study amendments that NHS organisations need to review for continuing

NHS Permission, thereby speeding up the timelines of amendments that do need review. The process is run in

parallel to regulatory review, the principle of a 35 calendar day default approval of amendments for NHS

organisations and introduces the categorisation of amendments into Category A, B, or C.

Category A - An amendment that impacts or affects ALL participating NHS organisations therefore

needs to be considered and may need change control actions.

Category B - An amendment that impacts or affects SPECIFIC participating NHS organisations. Only at

these organisations does it need to be considered and take any change control actions required.

Category C - An amendment that has no impact on NHS organisations hence does not require

management or oversight. R&D do not need to be notified of such amendments, however will have

access to all documents within the NIHR management system.

The new process will benefit both researchers and NHS organisations by reducing over-processing and

minimising unnecessary delays to the implementation of Category C amendments.

YHCS processes all amendments according to the agreed research assurance protocol with Leeds West CCG

and National Guidance as above on the appropriate approvals for the amendment types.

56 study amendments have been processed on behalf of Leeds West CCG throughout 2014/15. Figure 2 shows

the number of study amendments processed by YHCS on behalf of Leeds West CCG, broken down by month,

from 1st April 2014 to 31st March 2015.

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Figure 2. Number of amendments processed

Letters of access for research and honorary research contracts

Alongside the assurance/permission process, letters of access and honorary research contracts are needed to

engage and allow researchers to commence their research study. Research within the NHS is often undertaken

by NHS staff not directly employed by the host NHS organisation, or by non-NHS staff, particularly researchers

employed by universities. This raises issues about responsibility, accountability, patient safety and duty of

care. Research is also frequently undertaken across a number of NHS organisations and requires arrangements

for both NHS and non-NHS staff to work across those organisations. The Research Governance Framework

requires all parties undertaking research within the NHS to be clear about responsibilities and liabilities.

YHCS uses the UK Department of Health’s HR good practice resource pack to ensure a consistent approach to

handling arrangements for those undertaking research in the NHS.

In total 21 letters of access were granted on behalf of Leeds West CCG throughout 2014/15.

Figure 3 shows the number of letters of access issued by YHCS on behalf of Leeds West CCG, broken down by

month, from 1st April 2014 to 31st March 2015.

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Figure 3. Number of letters of access issued

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Research Development and Management Research Development Portfolio

YHCS works with a host of academic and NHS organisations, on behalf of the CCG, to facilitate the

development of research that addresses local and national commissioning priorities.

Below are summaries of a few of the current research projects supported by the YHCS research team and of

research grants in development.

Research projects in delivery

Action to Support Practices Implementing Research Evidence – ASPIRE

Action to Support Practices Implementing Research Evidence (ASPIRE) is a five year, £2 million programme

funded by the NIHR for General Practice in West Yorkshire which will produce findings of international interest

and significance. The aim of ASPIRE is to produce sustainable, feasible, cost-effective interventions that will

improve performance and, ultimately, improve patient outcomes. Thus, the results will be of benefit to wider

primary care.

The ASPIRE programme comprises of five main work packages. First, the team identified a selection of high-

impact recommendations, where a measurable change in clinical practice is likely to lead significant patient

benefit. Second, levels of adherence to these recommendations have been measured using analysis of

routinely collected data. Third, local health professionals (GPs, nurses, practice managers) have been

interviewed about the recommendations, with the purpose of identifying the key factors that help or hinder

their delivery. Based upon the results of the interviews, and following a process of discussion with other

stakeholders, an intervention package will be developed. This package will aim to support the implementation

of the selected evidence-based recommendations into clinical practice. The fourth work package is a full trial

of the intervention package, in a random sample of practices across West Yorkshire. The fifth work package is

a ‘process evaluation’ that runs alongside the trial and examines how the approach works and whether there

are any unintended consequences.

Currently work package four is in delivery with 178 practices randomised into trial arms of the intervention

package.

Improving the Management of Pain in patients with Advanced Cancer in the CommuniTy – IMPACCT

IMPACCT (Improving the management of pain in patients with advanced cancer in the community) is another

five-year, £2 million research programme funded by the NIHR. It is an integrated programme consisting of 4

work streams with a collective focus on enabling patients and carers to experience improved cancer pain

management within routine care. The programme began in June 2012 and is led by Mike Bennett, Professor of

Palliative Medicine at University of Leeds. It is the largest research grant ever awarded to support palliative

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care research in the UK and involves 15 research sites across primary and secondary care, incorporating

hospices, GP practices, and acute hospitals.

As part of the research programme the study team have undertaken an opioid prescribing project which has

resulted in the linkage of 14,000 patient records between Western and Yorkshire cancer registry, a hospital

oncology management system (PPM) and a primary care regional dataset (SystmOne). This is the first time

this linkage has been achieved and will result in a level of detail of prescribing and clinical information not

seen before.

Self-Management of Analgesia and Related Treatments at the End of life – SMARTE

The CCG is also working with Professor Mike Bennett on another project, the Self-Management of Analgesia

and Related Treatments at the End of life (SMARTE) funded by the NIHR Health Technology Assessment

programme. We are interested in adults (aged over 18 years) approaching the end of life, suffering from

significant pain and being cared for in their own home. The main aim of this study is to develop a support tool

that enables these patients and their carers to more confidently manage medications for pain as well as

constipation, nausea and drowsiness at home.

The objectives are divided into three distinct phases, in-line with the MRC framework on developing and

evaluating complex interventions, and with normalisation process.

a) Development objectives:

• Establish the content of a SMST that enables patients to better manage their

medications for pain relief, nausea, constipation and drowsiness (the intervention).

• Establish the content of a manualisation strategy that includes a protocol to

standardise (i) the training of HPCs and (ii) the delivery of the intervention.

• Understand and define usual care of management for pain relief, nausea,

constipation and drowsiness in this patient group.

b) Modelling objectives:

• Use experience based co-design with a sample of patients, informal carers and HCPs

to optimise the intervention regarding content and manualisation strategy, and the

acceptability of the planned consent and randomisation procedures.

c) Feasibility testing objectives:

• Gather data on the proposed trial processes from 4 palliative care services, in both

West Yorkshire and in Hampshire. This will involve evaluating the eligibility screening

process, participant consent, recruitment, retention, attrition.

• Assess the feasibility of obtaining clinical and health economic outcome data for a

definitive RCT including: change in medication use, improved symptom relief,

improved self-management efficacy/confidence, quality of life , acceptability of the

intervention, frequency of healthcare resource use, and place of death.

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• Conduct qualitative follow-up interviews with patients (where possible), carers and

HCPs to assess the acceptability, uptake and fidelity of the intervention.

All the described will be complete by the end of 2017 and the expected outputs are:

• A developed and refined self-management support tool and manualisation

strategy.

• A developed and refined protocol to train Clinical Nurse Specialists to deliver the

manualised intervention.

• Conclude whether the feasibility trial meets the success and progression

criteria for undertaking a definitive RCT.

Understanding the role of electronic systems in facilitating and supporting caregivers with symptom

reporting for palliative care patients

This research is supported by all three Leeds CCGs by funding the time of Dr Matt Allsop from the University of

Leeds. It aims to evaluate the role of ESR systems in enhancing support for caregivers of palliative care

patients by addressing three questions:

How do caregivers support symptom management for palliative care patients?

How do caregivers engage with a real-time ESR system?

What role can ESR systems play in facilitating communication and support for symptom management

by caregivers?

Increasing numbers of palliative care patients want to die at home but this presents challenges in terms of

accessing clinical advice for symptom management. New ways of supporting palliative care patients and their

caregivers are emerging from the rapid development of electronic devices available in the United Kingdom.

These can be used to enable health professionals to receive immediate alerts of patient symptoms, undertake

more detailed assessment and monitoring, provide timely advice on self-management or organise face-to-face

contact. While patient perspectives are starting to be gathered to inform the design of electronic symptom

reporting (ESR) systems, the role of caregivers and the way in which they can support and benefit from the

use of such systems is not well understood. Caregivers play a crucial role in supporting patients at home and

so their perspectives are integral in ensuring electronic systems provide a meaningful and effective role in the

care of patients with palliative care needs.

This project will purposively sample 24 caregivers of palliative care patients with advanced cancer, chronic

obstructive pulmonary disease and heart failure. Caregivers will pilot an ESR system with semi-structured

interviews taking place prior to and following its use. Interviews will explore caregiver perspectives of existing

symptom management, the use of electronic systems for reporting and develop a ‘theory of use’ to inform

implementation of existing and emerging systems.

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The findings will inform a caregiver perspective to ESR systems that are being developed for NHS use in Leeds.

Research findings will also have direct relevance to international research groups who have established links

with the team. The findings will be discussed and refined through a dissemination meeting with caregivers and

patients involved in the project, palliative care healthcare professionals, and local commissioners, prior to

reporting in research articles. Findings from the project will drive collaboration and generate further

opportunities to extend research around the use of electronic systems in palliative care.

Time4PallCare

YHCS are currently working with Dr Lucy Ziegler who is a Senior Research Fellow in the Academic Unit of

Palliative Care, Leeds Institute of Health Sciences. We are aiming to determine when and how to involve

palliative care services in the care of cancer patients and to identify groups of patients who are not currently

referred. Dr Pablo Martin, the CCG lead for Palliative Care is also a co- applicant in this work. Currently 30% of

cancer patients die without receiving specialist palliative care. For those who are referred, it is often in the last

weeks or days of life. Research evidence shows involvement of palliative care alongside routine cancer care

improves symptoms, reduces hospital admissions, improves quality of life and enables patients to make

choices about their end of life care. Despite the growing evidence about potential benefits of integrating

palliative care alongside cancer care, there is no evidence available about the most appropriate time to refer

patients or which patients to prioritise. Without this information oncologists cannot translate this research

evidence in practice.

We have successfully submitted a funding application to the Yorkshire Cancer Research fund to address this

gap in knowledge by using data from the electronic medical records of 7,000 patients who died from cancer

between 2008 and 2012. The data is located within 3 systems; i) The Yorkshire Cancer Registry ii) the

electronic patient record system used by the Leeds Cancer Centre and iii) the electronic patient record system

used by GPs and community palliative care teams. A process to access and link data from these three systems

has already been established and successfully executed by the research team as part of the IMPACCT NIHR

programme grant. In this project we will exploit this existing linkage. The team will track the timing and nature

of palliative care involvement and the extent to which quality markers for end of life care are met for each of

the 7,000 patients.

OK Diabetes

Working with Allan House, Professor of Liaison Psychiatry, University of Leeds, YHCS and the CCG member

practices are involved with OK Diabetes study. The aim of this study is to develop and evaluate a simple case

finding method to identify participants who have both mild/moderate Learning Disability and Type 2 diabetes

who are not taking insulin and who might be suitable for supported self-management. In addition, the work

will:

Develop a manualised intervention to aid supported self- management of diabetes; the manual will be

designed to balance the needs for a standardised approach against the need to take into account

variability in the eligible population in personal function and in availability of a supporter involved in

diabetes management.

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Assess the feasibility of delivering the intervention via qualitative interviews.

Develop a simple measure of adherence to the manualised intervention

Develop procedures for determining and recording capacity and obtaining consent.

The prevalence of type 2 diabetes, which varies markedly by ethnicity and social deprivation, has increased

sharply in recent years - in line with increasing obesity in the general population. Case finding for service

planning and for research is greatly facilitated in the UK by the fact that general practitioners are required to

maintain a register of all patients with diabetes, and are remunerated through the Quality Outcomes

Framework (QOF).

Supported self-management health interventions are now reasonably well established and such an

intervention would appear to be an appropriate approach to the care of people with LD who have type 2

diabetes. In order to conduct a feasibility trial of supported self-management for type 2 diabetes in adults

with mild to moderate LD there is a need to be able to clearly identify the target population; This is, however,

not straightforward. LD is difficult to define, especially at the milder end of the spectrum. It is often said that

2% of the general population will have some degree of LD but part of the problem is that any functional deficit

may not be entirely attributable to intellectual impairment but to emotional or social problems or missed

schooling, for example. Conversely, an adult with LD may not come to the attention of statutory or non-

statutory agencies if he or she is functioning independently or is well supported by family or some other

informal carer.

A corollary of the definitional problem is one of case finding. It is well recognized that a minority – probably a

quarter or less of the adult population with LD – is known to health or social services. For example in Leeds

only 75/27000(0.3%) of those on QOF diabetes registers are also on GP learning disability registers. Assuming

2% adults have a LD, the respective numbers should be nearer 540. This is unfortunate because it is apparent

that adults with LD have high rates of physical illness including diabetes and a recent government report

highlighted their poor levels of healthcare.

There are a number of possible explanations for high rates of poorly controlled type 2 diabetes in adults with

LD: high prevalence of obesity, poor dietary habits, low levels of activity, prescription medications that

increase obesity risk, and poor self-management skills. One further issue is that many adults with LD do not

live entirely independently even when they can be defined as living in the community. Family members and

other informal or formal supporters often help with shopping, cooking, monitoring of health and prompting

about medication, for example. Arrangements here are diverse: some adults with LD reside in the parental

home, some live with a sibling or other relative, some live alone or in shared accommodation with non-

resident support or peer support, some are married or cohabiting with somebody who may or may not

themselves have a LD. The issues of definition, case finding and complexity of living arrangements therefore

make it essential that prospective case finding research is carried out prior to running a feasibility trial of the

self-management intervention.

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Research projects in development

AlaBAMA: AntiBiotic Allergy and Microbial ResistAnce: Penicillin allergy status and its effect on

antimicrobial prescribing, patient outcomes, and antimicrobial resistance.

In response to the NIHR antimicrobial resistance themed call, Dr Jonathan Sandoe from the Leeds Teaching

Hospitals Trust has submitted a research proposal (AlaBAMA) to the NIHR Programme Grant for Applied

Research (PGfAR) funding stream. As the work proposed will initially use electronic health records for research

(eHRR) Leeds CCGs working with the YHCS are supporting Dr Sandoe to gather this data to answer his key

questions:

• Whether patients with a recorded allergy to penicillin are more likely to carry resistant

bacteria;

• How many people have a penicillin allergy and how this affects antibiotic use;

• In those patients with a recorded allergy to penicillin how this affects patient outcomes

(such as admission to hospital, intensive care or death);

• Then, in preparation for conducting a clinical trial of penicillin allergy testing, explore how

patients and their doctors would feel about being tested, and potentially taking penicillin

again; and,

• Discover if introducing a penicillin allergy testing pathway (in patients with a recorded

penicillin allergy and a high risk of infection) can change antibiotic prescribing and

reduce the amount of resistant bacteria.

The expected patient benefits from this study arise in those who have their allergy status changed and can

resume penicillin treatment which is often the best antibiotic for many types of infection. Societal benefits

arise from changes in antibiotic prescribing that reduce resistant bacteria. NHS benefits come from reduced

cost from avoiding less good, more costly alternative antibiotics and improved infection management.

A multi-stage randomised trial evaluation of clinical decision rules in the management of suspected heart

failure in primary care assessing diagnostic accuracy, patient outcomes and experience, and cost-

effectiveness

With the support of YHCS working on behalf of all three Leeds CCGs, Dr Klaus Witte, Senior Lecturer in

Cardiology, Consultant Cardiologist and Lead Clinician for Cardiology LTHT has submitted an application to the

NIHR Programme Grants for Applied Research.

The purpose of this research programme is to identify the optimal pathway for detecting heart failure (HF) in

primary care in terms of patient experience and outcomes, and cost-effectiveness.

This will be delivered in three work streams:

Work stream 1 will be a multi-arm, multi-stage cluster-randomised evaluation of clinical decision rules (CDRs)

for the detection of HF in primary care to:

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Identify optimised CDR for HF detection,

Compare effects on healthcare use and patient outcomes of CDR for HF diagnosis against

recommended practice,

Compare effects on outcomes for patients with and without left ventricular systolic dysfunction

(LVSD).

Work stream 2 is a qualitative exploration of HF referral processes and diagnostic pathways from perspectives

of healthcare professionals and patients to:

Explore how GPs and patients perceive/respond to current HF diagnostic pathways

Undertake concurrent process evaluation to explore responses to a new CDR and how it aligns

within existing process.

Work stream 3 will be an economic evaluation and model of a new CDR and pathway for HF diagnosis using

service use and patient outcomes data and describe:

What is the cost-effectiveness of the new CDR for HF diagnosis?

How does the patient through flow resulting from new CDR impact on cost-effectiveness?

We have been informed that the application has successfully made it through the first round of peer review

and have been invited to submit to the second stage of application.

Pilot study: Second-line treatment of irritable bowel syndrome patients in primary care with amitriptyline at low dose (The TRIBAL study) – a randomised controlled trial IBS is a concern, prevalence is between 5% and 20%, and accounts for >/=3% of all consultations in primary

care with a resulting cost to the health service in the UK of over £200 million per year. The quality of life of

sufferers is significantly impaired and medical management is unsatisfactory, with no therapy proven to alter

the long-term natural history and at best only modest symptom reduction. YHCS are working with the

University of Leeds Clinical Trials Unit and have recently submitted an application to the NIHR RfPB to explore

the second-line treatment of irritable bowel syndrome patients in primary care with amitriptyline at low dose.

The research proposed will offer insight and lead to further investigation that will provide a better

understanding of treatment of IBS in this setting, delivering new information that could lead to a real change

in the way that IBS is managed in primary care. The NICE guidelines acknowledge the evidence base is not

strong in the area of management of IBS in primary care, stating that healthcare professionals should

“consider” TCADs (e.g. amitriptyline) as second-line treatment for IBS if laxatives, loperamide or

antispasmodics have not helped. Potentially then, as a result of this research, the use of these drugs in this

setting will be more strongly advocated by revised national guidelines. This could lead to better control of IBS

symptoms, improved quality of life of people with IBS, and reduced costs of managing IBS in secondary care.

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Research Capability Funding (RCF)

RCF 2015-16:

On 25th March 2015 YHCS launched a call to researchers within West Yorkshire for applications for Research

Capability Funding (RCF), with the deadline for applications being 12 noon on 27th April 2015. RCF is a quality

driven fund which is supported by the National Institute for Health Research to promote and develop patient

and people based research.

The purpose of the fund is outlined below:

To assist research active NHS organisations to sustain research capacity and capability

To develop, maintain and preserve workforce undertaking or supporting people or patient based

research

To contribute towards the costs of hosting NIHR-funded or adopted research that are not currently

fully across other NIHR programmes

A panel will meet during the first quarter of 2015-16 to consider the funding applications and allocation of

funds. The review panel will include academics, clinicians and CCG members.

RCF offers a number of benefits to NHS organisations, for example:

Access to flexible funding

A means for developing and sustaining research capability, meeting the costs of key research support

staff not funded in other ways

Helping to build critical mass, as increased research capacity attracts additional NIHR research income

and so attracts a greater share of Research Capability Funding

Providing a financial contribution towards the costs incurred through research active NHS

organisations hosting NIHR-funded or ‘adopted’ research

Funding for developing research management capabilities in those Trusts where R&D departments

have been reconfigured within NHS research support services

RCF 2014-15:

A panel was held on 25th July 2014 to allocate the 2014-15 Research Capability Funding awards.

The 2014-15 funds were allocated as follows:

21

RCF-2014-001 - Alison Blenkinsopp, University of Bradford: To contribute to a growing programme of

research led by academics at the University of Bradford aiming to make better use of medicines and

reduce avoidable harm for patients being discharged from hospital into primary care.

RCF-2014-002 - Anne Forster, Bradford Institute for Health Research: To build on clinical work to

develop and evaluate an intervention to optimise and maintain upper limb function after post-stroke

impairment.

RCF-2014-003 - Robbie Foy, University of Leeds: To ensure that there be a locally grown candidate

available for an externally funded NIHR academic clinical lecturer post from 2015.

RCF-2014-005 - Jenny Hewison, University of Leeds: To support pilot work necessary to inform a

substantial NIHR research proposal focusing on the treatment of musculoskeletal conditions in Primary

Care.

RCF-2014-006 - Suzanne Heywood-Everett, Bradford District Care Trust: To carry out a preliminary

study with an aim to support a future bid to conduct a large scale project, focusing on access to

Mental Health Services (MHS) for people with eating disorders, namely access for people from South

Asian (SA) backgrounds.

RCF-2014-007 - Allan House, University of Leeds: To design, build and test a resource based on a

blueprint for a free, generic online resource to introduce patients to involvement, support the

acquisition of knowledge and skills, and signpost them to opportunities to become involved in

healthcare research and development.

RCF-2014-010 - Mike Lucock, University of Huddersfield: To investigate the clinical outcomes and

processes (variables that moderate and/or facilitate symptom improvement) associated with high

volume psycho-educational stress control classes that are routinely offered in psychological therapy

services aligned to the national IAPT programme (Improving Access to Psychological Therapies).

RCF-2014-011 - Dean McMillan, University of York: To support developmental work ahead of a

submission of a grant application to a NIHR-funding stream for a trial of a low-cost, easy-to-deliver

treatment for insomnia in older adults for use in primary care settings.

RCF-2014-012 - Mohammed A Mohammed, University of Bradford: To fund a non-clinical senior

research fellow (RF) post with the specific remit of supporting primary care research across the region

(the establishment of a Professorship in Healthcare, Quality & Effectiveness).

RCF-2014-014 - Shubhra Singh, Bradford Districts Care Trust: To enable Bradford District Care Trust in

partnership with Bradford Dementia Group and Bradford City & Districts CCGs to carry out the

exploratory developmental work required prior to submission of a bid for more substantial funding to

the ESRC for a project grant to improve the care pathway for minority ethnic families where someone

has dementia.

22

Research Engagement

YHCS develops research engagement within the CCG, increasing engagement through promotion of local

research studies and their delivery requirements to CCG member practices.

Study Recruitment

Throughout 2014/15 member practices of NHS Leeds West CCG have recruited 104 participants into research

studies. Figure 4 shows the CCG’s recruitment figures in comparison to the other nine West Yorkshire CCGs

throughout 2014/15.

Figure 4. Study recruitment in West Yorkshire 2014 - 2015

Within NHS Leeds West CCG 51% (n=19) of practices including the CCG as a research site have recruited

participants into research. The NIHR Clinical Research Network (CRN) performance and operating framework

2014-15 highlights a primary care specialty specific target of 5% for the proportion of GP sites within any

individual CCG registered as research capable with the NIHR CRN.

An NIHR CRN overarching objective is that 25% of General Medical Practices will recruit into NIHR CRN

Portfolio Studies, however when considered as a region West Yorkshire has achieved 37.6%.

YHCS is keen to further develop research engagement within the CCG through a collaborative approach. We

intend to increase engagement through further promotion of local research studies and their delivery

requirements to CCG member practices. We will do this by providing regular input into the CCG newsletters,

feeding into Practice Manager meetings, attending TARGET events and any other opportunities that arise.

Figure 5 below breaks down recruitment by practice and study.

23

Figure 5. Study recruitment

24

Network Meetings

Throughout 2014, on behalf of the CCG, YHCS organised and delivered research network meetings. These

meetings were an opportunity for research interested and active primary care practitioners to meet and share

best practice and to receive information about local research projects being developed or delivered. All

research active practices were given the opportunity to host a meeting.

Over the last year we have had the kind assistance of the practices across Leeds and have hosted events at:

Whitehall Surgery on the 29th April 2014

New Croft Surgery on the 23rd July 2014

Craven Road Surgery on the 14th October 2014

Network meeting at Whitehall Surgery on the 29th April 2014

ADDRESS-PMR

Louise Sorensen presented information about ADDRESS-PMR. ADDRESS-PMR is an NIHR-funded

research study, led by Dr Sarah Mackie with the aim of improving the diagnosis of polymyalgia

rheumatica (PMR), a common inflammatory musculoskeletal disease affecting older people.

Individual Funding Requests

John Callaghan of the University of Leeds presented on a study of decision making on a local individual

funding request panel (IFRP), presenting findings which suggest that important benefits arise from

inter-professional, professional-lay, and ethnic diversity among decision-making groups. John also

talked about another study relating to IFR, which aimed not only to explore these issues in more detail

but also to identify factors which prevent GPs from making effective IFR submissions and to suggest

interventions which might support them in the process.

Cost and Economic Evaluation of the Leeds Personality Disorder Managed Clinical Network; a service

and commissioning development initiative

This health economic evaluation aimed to provide both an analysis of the cost and economic impacts

of the PD Network, and a replicable model for commissioners and providers to use in calculating the

benefits and/or lack of benefits of particular investment decisions.

Network meeting at New Croft Surgery on the 23rd July 2014

SMARTE

The study team from the University of Leeds presented on the Self-Management of Analgesia and

Related Treatments at the End of life (SMARTE) study, which aims to develop a support tool to

improve the management of medications for pain relief, nausea, constipation and drowsiness in

patients with significant pain approaching the end of life.

Research Service Annual Report 2014-2015 25

ASPIRE

Emma Ingleson delivered a presentation about ASPIRE (Action to Support Practices Implementing

Research Evidence), an NIHR-funded research programme with the aim to develop and test ways to

support general practices in implementing evidence-based practice effectively and realistically within

the constraints and challenges of real-life general practice.

Craven Road Surgery on the 14th October 2014

SASS (Symptoms Awareness Study)

Julie Walabykei, project researcher, presented preliminary data from SASS, a study looking at

awareness of relevant cancer symptoms for lung and head and neck cancers among smokers.

HI-TEC (Handling Inhalers - Technique Error Comparison)

HI-TEC is a study comparing patients’ usage of different types of inhaler.

TARGET Events

Throughout 2014/15 YHCS has been working with CCG member practices to establish a research community

across the locality; the aim of this is to provide a platform for increased engagement, for development

opportunities to be explored and to enable knowledge transfer.

YHCS have continued to develop engagement with member practices in the Leeds West area by attending

TARGET events. Attending these events provides an opportunity to provide information about the service and

to answer any questions that general practitioners, nurses and practice managers have about conducting and

participating in research in primary care.

Members of the research team attended the TARGET events held on 20th November 2014, 26th February

2015 and are registered to attend the event that will be held on 30th April 2015 at the Mercure Parkway Hotel

on Otley Road, Leeds.

In November and February representatives of the service held a table at the event, sharing leaflets and

information sheets about research within primary care in West Yorkshire and communicating with attendees

the ways in which they could access and engage with research. By continuing to attend these events the

service aims to give research a stronger presence within the area whilst promoting a culture of good quality

research within the NHS.

Research Service Annual Report 2014-2015 26

Practice Management

During 2014/15 YHCS research team have formulated a training package designed to provide an overview of

research and its requirements within primary care. This has been created for GPs, practice managers and

administrators and provides a background to research and its practical requirements. The training also

includes a checklist for practices outlining what they should be looking for when a study approaches the

practice for inclusion to ensure good practice. YHCS will be rolling out this training in 2015-16.

27

Knowledge Transfer

The translation and integration of evidence synthesized from the delivery of research is a national priority.

Effective Knowledge Transfer can improve the service we deliver to patients through the sharing of best

practice.

Applying Research evidence in Commissioning Decisions (ARC) Forums

Throughout 2014 the YHCS Research Service team delivered a series of themed events in support of NHS

England’s aim to deliver its statutory duties to promote the use of research and the use of evidence obtained

from high quality research.

The Applying Research evidence in Commissioning decisions (ARC) forums comprised of themed discussion

sessions, bringing together eminent academic researchers, CCG clinical and commissioning leads, Public

Health, pharmacy and broader health community representatives to encourage collaboration and to promote

evidence-based commissioning.

Sessions began with a presentation from a leading academic on a topic of current high priority for local CCGs,

followed by an interactive discussion led by both a CCG commissioning/clinical lead and the presenting

academic. Round table discussions and debate was facilitated to draw out key implementable evidence for the

CCG commissioning and clinical leads to take away.

A list of the topics and keynotes speakers for the 2014-15 ARC forums has been included below:

Date Topic Keynote Speaker

1st May Patient Safety Professor Rebecca Lawton

25th June Mental Health: Adults Professor Simon Gilbody

17th July Mental Health: Children & Young People Professor David Cottrell

24th September Managing Long Term Conditions Professor Allan House

16th October Palliative & End of Life Care Professor Mike Bennett

12th November Patient Experience Dr Jess Drinkwater

In total 100% of attendees fed back that they would recommend/strongly recommend the ARC forums to

others. For more information on the ARC forum sessions, including information about the topics explored as

well as the feedback received from commissioners, please find attached ARC report (appendix three).

Research Service Annual Report 2014-2015 28

Understanding prescribing of opioids for chronic non-cancer pain in general practice

On the 23rd September 2014, YHCS hosted a dissemination event entitled, “Prescribing of opioids for chronic,

non-cancer pain: challenges and opportunities for general practice” at Weetwood Hall Conference Centre,

Leeds.

The study team led by Professor Robbie Foy, University of Leeds and supported by YHCS completed a 2-year

study to understand more about opioid prescribing for chronic, non-cancer pain in general practice. Over 100

general practices across Bradford and Leeds participated.

The event brought together general practitioners, patients, specialists and researchers to:

Highlight and explain the problem of rising opioid prescribing for chronic, non-cancer pain in general

practice

Consider actions that commissioners and practices can take to reduce problematic opioid prescribing

Gauge appetite for further research on opioid prescribing

The main objectives of the research were to:

Examine patterns and trends in long term prescribing of opioids in general practice

Explore the experiences, beliefs and expectations of patients and general practitioners (GPs) in

relation to long term prescribing of opioids, and delineate the trajectories by which patients become

long term users of potent (‘strong’) opioids

Please see appendix four for further information about the study.

Research Service Annual Report 2014-2015 29

Glossary

Academic Health Science Networks (AHSN) - See Yorkshire and Humber Academic Health Science Network

http://www.england.nhs.uk/ourwork/part-rel/ahsn/

Academy of Medical Sciences - Founded in 1998, the Academy of Medical Sciences is the independent body in

the UK that represents the diverse spectrum of medical science – from basic research through clinical

application to healthcare delivery. Its mission is to promote medical science and its translation into benefits for

society http://www.acmedsci.ac.uk/

Bradford Institute for Health Research (BIHR) - An organisation set up in 2007 to conduct research activity in

the Bradford area, in partnership with universities and embedded within the NHS

http://www.bradfordresearch.nhs.uk/

Chief Investigator (CI) - The lead investigator with overall responsibility for the research. In a multi-site study,

the CI has coordinating responsibility for research at all sites. The CI may also be PI (Principal Investigator) at the

site in which they work. In the case of a single-site study, the CI and the PI will normally be the same person and

are referred to as the PI.

Collaborations for Leadership in Applied Health Research (CLAHRC) - Collaborative partnerships between a

University and surrounding NHS organisations, which undertake high-quality applied health research focused on

the needs of patients and support the translation of research evidence into practice in the NHS

http://www.nihr.ac.uk/about/collaborations-for-leadership-in-applied-health-research-and-care.htm

Comprehensive Local Research Network (CLRN) - See NIHR

CSP - NIHR Coordinated System for gaining NHS Permission: Standard process for adoption onto NIHR Portfolio

of Studies in order to access NIHR CRN Support and funding; streamlines the process for gaining NHS

permissions by collating the information for global and local approvals.

Good Clinical Practice (GCP) - Defined standards for the terminology, design, conduct, monitoring, recording,

analysis and reporting of a study. These standards give assurance that the reported results are accurate and

credible and that the rights, integrity and confidentiality of all study participants have been protected

throughout the study.

Good practice resource pack - A pack which describes the process for handling HR arrangements for researchers

/ provides a streamlined approach for confirming details of their pre-engagement checks

http://www.nihr.ac.uk/policy-and-standards/research-passports.htm

Health and Social Care Act 2012

http://www.legislation.gov.uk/ukpga/2012/7/contents/enacted

Research Service Annual Report 2014-2015 30

Health Research Authority (HRA) - The HRA was established in December 2011 to promote and protect the

interests of patients in health research and to streamline the regulation of research http://www.hra.nhs.uk/

Health Technology Assessment (HTA) - The HTA Programme is the largest of the NIHR programmes. It funds

independent research about the effectiveness, costs and broader impact of healthcare treatments and tests for

those who plan, provide or receive care in the NHS. Their studies are funded via a number of routes

including commissioned and researcher-led work streams http://www.nets.nihr.ac.uk/programmes/hta

Honorary Research Contracts - If you are coming to work at the Trust without a paid contract then we will issue

you with an honorary contract. We are bound to issue these contracts to visitors to the Trust. If you are

a clinician, researcher, manager or in any other role and you join us for the purposes of education and/or to gain

experience we will give you a contract of this type.

In addition, if your clinical interaction, research activity or period of education or observation involves Trust

employees or patients; or the use of their organs, tissue or data then we are bound to issue with an honorary

contract.

This is to ensure you are bound to take proper account of the NHS ‘duty of care’; and that the Trust in turn

discharges its own ‘duty of care’ for the individual.

Letter of Access - The research passport system provides a mechanism for Higher Education Institution (HEI)

employers to share pre-engagement information about a researcher with relevant NHS organisations in which

that researcher will be conducting their research activity.

If you are not an NHS employee, you will need to complete a research passport. If you are an NHS employee, an

NHS to NHS Proforma is completed.

A research passport is:

a set of checks on a researcher conducting research in the NHS

a standard form for each researcher to complete

completed by the researcher and his/her employer, and validated by an NHS organisation

a streamlined process for obtaining permission for research.

A research passport may be valid for the duration of a project or for a maximum of three years. Once the checks

have been completed and a valid research passport has been issued, the checks may be relied upon for the

duration of the research passport.

A letter of access or honorary research contract will be issued dependant on type of research activity being

undertaken, on receipt of a valid research passport application or valid NHS to NHS Proforma.

Research Service Annual Report 2014-2015 31

National Institute for Health Research (NIHR) - Established by the Department of Health for England in 2006 to

provide a framework through which the DoH will position, manage and maintain the research, research staff

and infrastructure of the NHS in England as a virtual national research facility

http://www.nihr.ac.uk/Pages/default.aspx

NHS Constitution -

http://www.nhs.uk/choiceintheNHS/Rightsandpledges/NHSConstitution/Pages/Overview.aspx

NIHR CRN (formerly known as PCRN and WYCLRN) - In 2006, the Department of Health set up the National

Institute for Health Research to create a world-class health system within the NHS, and the Clinical Research

Network is part of this wider organisation. At the centre of what we do is the Portfolio – a collection of high-

quality clinical studies that benefit from the infrastructure provided by the Clinical Research Network. Many of

these studies are Randomized Controlled Trials – considered by many in the medical profession to be the most

robust form of clinical trial – although we also support other types of well-designed research.

Northern and Yorkshire Cancer Registry - The Northern and Yorkshire Cancer Teams (Public Health England)

monitor patterns of cancer in Yorkshire and the north east of England - via the collection, analysis,

interpretation and dissemination of population-based cancer data http://www.nycris.nhs.uk/

Plan for Growth -

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/31584/2011budget_growth.p

df

Principal investigator (PI) - The lead person at a single site designated as taking responsibility within the

research team for the conduct of the study.

Programme Grant for Applied Research (PGfAR) - NIHR Programme Grants for Applied Research (PGfAR) were

established in 2006 to produce independent research findings that will have practical application for the benefit

of patients and the NHS in the relatively near future http://www.ccf.nihr.ac.uk/PGfAR/Pages/Home.aspx

Research Capability Fund - Research Capability Funding is allocated to research-active NHS organisations in

proportion to the total amount of other NIHR income received by that organisation, and on the number of NIHR

Senior Investigators associated with the organisation. Research Capability Funding (RCF) is also allocated to

NIHR Clinical Research Networks for their local research networks, via the NHS organisations that host each local

network http://www.nihr.ac.uk/policy-and-standards/research-capability-funding.htm

Research Governance Framework - DoH guidance for the conduct of research within the NHS in England.

Research Passport - A system for HEI employed researchers / postgraduate students who need to undertake

their research within NHS organisations, which provides evidence of pre-employment checks undertaken on

that person in line with NHS Employment Check Standards (among them CRB and occupational health checks).

Research Service Annual Report 2014-2015 32

Research Support Services (RSS) - A set of tools and guidelines to support a consistent and streamlined

approach to managing health research studies in the NHS. The RSS framework was developed in collaboration

with a wide range of stakeholders, including senior R&D managers and investigators, who identified research

processes that could be speeded up or simplified and steered working solutions to help overcome problems

http://www.nihr.ac.uk/policy-and-standards/framework-for-research-support-services.htm

Standard Operating Procedures (SOPs) - Detailed written instructions designed to achieve uniformity of the

performance of a specific function.

Yorkshire and Humber AHSN - The Yorkshire and Humber Academic Health Science Network is one of 15 new

innovative health networks set up to create and harness a strong, purposeful partnership between patients,

health services, industry, and academia to achieve a significant improvement in the health and wealth of the

population. The Network was given license to operate by NHS England in May 2013.

The purpose of the Yorkshire and Humber Academic Health Science Network is to create world-class

partnerships to transform healthcare and bring prosperity and wealth to the region. We will do this by working

closely with NHS partners, universities, local authorities and industry to bring services and products that have

the potential to transform lives to routine clinical practice by working closely with NHS partners, universities,

local authorities and industry.

The Yorkshire and Humber Academic Health Science Network will generate significant added value for partner

organisations by reducing service variability and improving patient experience. The Yorkshire and Humber

Academic Health Science Network will also enable partners to improve efficiency and effectiveness and

collectively create an environment that supports inward business investment leading to economic growth. The

Yorkshire and Humber Academic Health Science Network will become a partner of choice for local, national and

international businesses wishing to innovate in the health sector.

Some definitions taken from Introduction to Good Clinical Practice (GCP) v2.2.

Research Service Annual Report 2014-2015 33

Appendices Appendix One: Team Structure and Biographies Until October 2014 the Research Service sat within the Transformation, Organisational Development and

Research Business Unit of West and South Yorkshire and Bassetlaw Commissioning Support Unit (WSYBCSU).

Following the merger of WSYBCSU with North Yorkshire and Humber Commissioning Support Unit the service

sat within the YHCS Nursing Directorate, led by Director of Nursing Lynn Poucher.

The West Yorkshire YHCS Research service team provide support in various ways, including:

Help in building CCG portfolios of research studies by working with local universities and NHS trusts to

identify local research priorities

Building and maintaining strong working relationships with all partners and stakeholders

Acting as the lead NHS organisation for all grants awarded, providing comprehensive management and

governance of research projects to ensure compliance with all statutory obligations

Working on behalf of CCGs to promote and implement research findings into practice

Developing bids for national grants in partnership with universities, NHS trusts and other NHS health

and social care organisations to support research priorities

The YHCS Research Service is provided to all ten CCGs within West Yorkshire

The Research Team

The Research team comprises of:

Erica Warren, Head of Primary Care Research Service and Head of Health Economics, Evaluation and

Evidence Service

Paul Carder, Senior Associate – Research and Health Economics, Evidence and Evaluation Service

Stella Johnson, Research Manager: Research Service

Rebecca Harper, Senior Associate: Research Service

Rosemary Dewey, Research Associate

Gemma Doran, Research Associate Team biographies

Below are the biographies of the YHCS West Yorkshire Research team:

34

35

36

37

38

39

40

Appendix Two: Summary Information on the studies which YHCS has granted NHS Assurance for on behalf of the NHS Leeds West CCG

Early evaluation of the Integrated Care and Support Pioneers

Chief Investigator: Dr Bob Evens, Deputy Director of the Policy Innovation Research Unit (PIRU), London

School of Hygiene and Tropical Medicine (LSHTM)

Principle Investigator: Professor Nicholas Mays, Professor of Health Policy LSHTM

Risk: Low

Cost to CCG: Approximately 40 minutes of participants time only

Start/End Date: 01/03/14 to 30/09/15

Brief overview of study:

This study is an academic study sponsored by the London School of Hygiene and Tropical Medicine and

funded by the Department of Health Policy Research Programme (£5,538,518).

The research is limited to participation of staff within the NHS and/ or voluntary sector only and does not

include patients or service users. This study is conducting an early evaluation of 14 competitively selected

Integrated Care and Support ‘Pioneers’ in the context of the deployment of the Better Care Fund. The

research team will work through each of the 14 Pioneer’s lead and NHS IQ contact person to identify the

relevant staff to be interviewed. Snowball sampling will also be used. The number will vary by site

depending on the diversity and scale of the integration initiatives within each Pioneer.

The purpose of the evaluation is to understand the ingredients of, and assess progress in England towards,

locally specified variants of vertical and horizontal ‘integration’ between health, social care and other

services designed to increase ‘person-centred coordinated care’.

The specific objective of this qualitative study will be to understand how ‘Pioneers’ conceptualise ‘greater

integration’ based on which success criteria; explore mechanisms (in terms of systems and causal

pathways) by which integrating activities are expected to impact on user outcomes; assess progress that

Pioneers have made during their first year of implementation and to assess the degree to which the Better

Care Fund (BCF) is used by ‘Pioneers’ to model their health and social care development models and how

they align with national performance requirements.

In order to maintain confidentiality the 14 Pioneers sites will be allocated a numerical identifier.

Anonymised quotations from participant interviews may be used in study reports or published articles.

Any quotations included will use the code assigned to the area and the participant’s role only (e.g. Site 1,

CCG member) and extra care will be taken to ensure that participants or organisations cannot be identified

through contextual information. Audio of the interviews will be recorded, with the participants' consent

and transcribed. Some direct quotes from the interviews may be used in reports, but these will not be

attributed to identifiable individuals.

41

GP Referral Patterns for Patients with Hearing Loss

Chief Investigator: Dr Sarah Isherwood, Lecturer, Faculty of Audiology, School of Healthcare, University of

Leeds

Risk: Low

Start/End Date: 10/03/14 – 16/04/14

CCG Costs/Income: N/A

Status: New study

Brief overview of study:

This study is being undertaken by a student as part of their MSc dissertation in order to achieve MSc in

Management and Leadership in Health and Social Care.

The study aims to investigate existing knowledge and attitude of GP’s for the referral of adults with

hearing loss to secondary care, and assess whether simplification of the guidelines and the use of

screening audiometry in primary care could prove beneficial in this process.

Potential participants will be identified as GP practices who routinely offer audiometric screening and

those who do not using the publicly accessible NHS Choices website. The researcher will contact the senior

partner of the GP practice to invite to participate, if so the senior partner will be asked to email the

researcher confirmation of their wish to take part.

Participants will be asked to complete questionnaire to assess GP’s existing knowledge and attitude when

assessing adults with hearing loss and identify whether simplification of the current referral guidelines

may assist them in making the most suitable referral for an individuals’ onward management. Additional

information will be derived from the questionnaire from GP practices where screening audiometry is

performed routinely and practices where this is not and question whether this has an effect on the patient

referral pathway.

This study is an academic study sponsored by the University of Leeds.

How Does Current PPI Affect Delivery of Primary Care

Chief Investigator: Dr Jessica Drinkwater, NIHR In-Practice Fellow, University of Leeds

Investigator: Professor Robbie Foy, University of Leeds

Risk: Low

Start/End Date: 01/05/14 – 30/11/14 (start/end dates are estimated at the time of application)

Brief overview of study:

The study aims to understand if and how current PPI affects the delivery of primary care. There will be

three stages:

42

1. Engaging with individuals involved in PPI activities and work with them in small groups to

explore their network, their role, and how this affects the delivery of primary care.

2. Observing PPI groups already established to explore what activities are happening and to

produce examples of how this may affect the delivery of primary care.

3. Reporting the results and using the examples to explore how PPI affects the quality of care

patients receive in primary care settings.

The researcher hopes for this study to be a basis for future research to investigate the impact of PPI

activities.

Potential participants will be identified as follows:

Co-researchers will be identified via engagement leads in clinical commissioning groups and

commissioning support units in Leeds and Manchester who have already shown an interest in

participating. These individuals will be asked to suggest names of other potentially interested

individuals.

The experience and informal networks of those within the co-researcher group will be used to

identify groups to approach for observation and at which level these should be (CCG, Healthwatch,

general practice). The research team will aim for a maximum variation of the groups observed

based on socio-economic areas and different group structures and potential roles.

Interviewees will be identified from the groups observed. All group members will be asked if they

are interested in taking part in an interview after the first meeting.

Participants will be asked to:

1. Identify PPI activity (problem identification and planning) – each group will be asked to produce a

map of PPI in their area and describe the roles of different groups. They will then be asked to

identify the PPI groups with the greatest influence on delivery of primary care. Co-researcher

groups will be made up of 1 CCG engagement lead, 1-3 CCG lay members, 1-2 HealthWatch

members, 2-4 PPG group members, 1 previous PPG member and 1-2 GP and/or Practice Manager

per group (total of 7-13 per group)

2. Observation of PPI groups (action) – meetings of established PPI groups will be observed to

explore their activities and whether these have potential to affect the delivery of primary care. For

each group two meetings will be observed and notes will be taken. Meeting documents will also

be analysed. A selection of participants will be interviewed about their experiences of PPI and how

they think this affects the delivery of primary care. These individuals will be asked to keep a diary

of PPI activities between the two meetings to aid the interview. Interviews will be recorded and

transcribed verbatim. Approximately 3 groups in Leeds and Manchester will be observed and 2-3

participants will be interviewed in each group. (The researcher has also applied to Manchester

R&D office).

3. Exploration of the potential of PPI to improve quality of delivery of primary care (evaluation) –

Group activity with co-researchers. The findings of part 2 will be shared with the co-researchers

who will be asked to comment, discuss, and reflect on the findings building on the analysis. The

43

case studies will also be used to discuss the potential for PPI to improve the quality of delivery of

primary care.

The results will be disseminated at a meeting of clinicians and academics in Leeds. The co-researchers will

also be asked to attend a final meeting at the end of the project to discuss dissemination of the findings

and future research questions.

This study is an academic study sponsored by the University of Leeds.

FADES - Feeding and Autoimmunity in Down's syndrome Evaluation Study

Chief Investigator: Dr Georgina Williams, University of Bristol

Risk: Low

Start/End Date: 01/05/14 to 01/05/22

CCG Costs/Income: N/A

Status: New study

Brief overview of study:

All participants will be recruited through the Down’s Syndrome Association (DSA) and Down’s Syndrome

Scotland (DSS) - NHS sites will not be involved in recruitment.

NHS Health Care Professionals will only be asked to assist with taking the blood samples at routine health

checks where parents do not feel confident to do this themselves.

This is a low risk study involving children with Down’s syndrome (DS), looking at their increased risk of

autoimmune conditions including thyroid problems, diabetes and coeliac disease. The study team aim to

develop a family acceptable study protocol and establish the feasibility of creating a national cohort of

infants with Down’s Syndrome (DS) to study the associations between early infant feeding, infections and

the development of autoimmunity in Down’s Syndrome. They anticipate that they will recruit 100 patients

nationally per year.

The study has been split into two phases:

Phase 1: applicable for the Bristol University Hospitals NHS Trust only

Phase 2: applicable to all participating sites and is detailed below.

Parents will be asked to complete questionnaires, which will be sent out and completed at home. These

will be completed at baseline detailing family history, birth history, weight, medical problems and early

feeding. They will have further feeding questionnaires to complete at 6 months and 12 months, and

medical questionnaires annually until the age of 5 years. The majority of the samples will be collected by

the parents at home and they have been given all the necessary instructions and equipment. Samples

taken at baseline will include faeces, a brushing from the infants cheek for genotyping (looking at their

DNA) a blood sample to look at development of autoantibody production (antibodies which act against

44

their own cells), and a urine specimen to detect development of diabetes. Further stool, urine and blood

samples are collected at 6 months and 12 months and once a year thereafter until 5 years of age. NHS

Health Care Professionals will only be asked to assist with taking the blood samples at routine health

checks. The blood samples at 12months and yearly thereafter can be taken at the same time as the

recommended annual thyroid check. No storage or processing of the samples will be required by the

participating sites. These are pre-labelled and the parents are provided with packaging in which to return

the samples.

This study has been set up as a partnership between the NIHR, Bristol Biomedical Research Unit in

Nutrition, The University of Bristol (sponsor), the Diabetes Research Group, Imperial College London, the

Department of Medicine, the Down’s syndrome Association and Down’s syndrome Scotland.

CADIAS - Cancer Diagnosis In the Acute Setting

Chief Investigator: Dr Thomas Newsom-Davis, Chelsea and Westminster Hospitals NHS Foundation Trust

Risk: Low

Start/End Date: 01/11/12 to 31/12/14

CCG Costs/Income: N/A

Status: New study

Brief overview of study:

This study will be recruiting patients (500) from across the country who are seen at the London Cancer

Alliance (LCA).

The United Kingdom has poorer cancer survival than other countries. Around one quarter of newly

diagnosed cancer patients present to hospital as an emergency. These patients have a significantly worse

one year survival and 14% have never seen their GP. The importance of emergency new cancer diagnoses

is therefore recognised at both a clinical and strategic level.

Previous work has been limited by looking separately at primary care or secondary care. This project

represents a unique opportunity to study all aspects of the patient journey. Through collaborative working

between secondary and primary care, the team will undertake an in depth study of patients presenting as

an emergency with a new cancer diagnosis. The results of this work will have implications for patients,

carers, doctors and healthcare providers throughout the UK.

The aims of the project are:

To understand the whole diagnostic pathway, from primary to secondary care and including

the views of the patient themselves, for those presenting as an emergency with a new cancer

diagnosis.

To gain an in depth understanding of the events that leads to a cancer patient receiving their

diagnosis as a result of an emergency admission.

45

To identify the clinical and organisational factors that contribute to an emergency new cancer

diagnosis, and to produce an action plan to target these factors.

Adult patients with lung or colorectal cancer presenting as part of an emergency admission to six hospitals

across the LCA will be involved in this 12 month project. Patients will be identified through established

clinical pathways and consented into the study in the secondary care setting.

Clinical information relating to their cancer diagnosis will then be obtained from secondary care records

and from their GP. The consent process (can opt not to provide consent for this) will include contacting

their GP in order to request completion of a significant event analysis (SEA) form (taking approx. 45

minutes to complete everything). GPs will receive £100 per patient for completing the form in full.

Another incentive is that the SEAs will be suitable for inclusion in QOF returns and for GP Revalidation.

It is important to note that this project will not be used as an opportunity to criticise the management in

primary or secondary care, nor an attempt to focus on missed diagnoses and mistakes. However, in

keeping with Good Medical Practice, professional obligation to patients means that if there were serious

concerns about a professional’s conduct, the team’s duty would be to involve the usual governance

mechanisms for that practitioner

Data will be scrutinised, including by using significant event analysis and root cause analysis.

The patient will also be invited to share their opinions in a confidential interview.

The results are expected to have wide implications for patients, doctors and the providers of cancer

services throughout the UK.

The study is sponsored by the Chelsea and Westminster Hospitals Foundation NHS Trust and funded by

the Department of Health (Cancer Policy), £150,000 for 12 months.

DSRU Fluenz - Flu vaccine study

Chief Investigator: Professor Saad Shakir, Director, Drug Safety Research Unit (DSRU), Southampton.

Risk: Low

Start/End Date: 26/08/14 – 27/02/15

CCG Costs/Income: N/A

Status: New study

Brief overview of study:

This study is a post authorisation safety non-interventional cohort study on the Department of Health live-

attenuated nasal influenza vaccine Fluenz Tetra ®. The aim of the study is to detect changes in the

frequency or severity of reactions to the vaccinations in children during the 2014/2015 influenza season.

The study is being conducted to satisfy the European Medicines Agency’s (EMA) requirement for enhanced

safety surveillance for seasonal influenza vaccines in the EU.

46

Patients will receive a study pack in GP surgeries by the practice nurse or other HCP who gives the

vaccination; or in schools by the school nurse or local NHS immunisation team or other trained staff who

provide vaccination. The patient will then complete an enrolment questionnaire, either by post or email

and sent two reminders (at day 7 and 11) to ask that they note down any symptoms experienced following

vaccination. Where children are under the age for consent, parent/guardian will consent on behalf of the

child.

The patient will be asked to complete Day 14 questionnaire and receive a £10 pre-paid voucher if they

have completed the study, or the DSRU will donate to charity. GP’s will be asked to complete a

questionnaire with details about vaccination and reactions, GP’s will be paid £30 for their time.

This study is a study funded by MedImmune LLC (£312,858 over 6 months) and sponsored by the Drug

Safety Research Unit (DSRU).

Injection versus SplinTing in Carpal Tunnel Syndrome (INSTinCTS)

Chief Investigator: Elaine Hay, Arthritis Research UK Primary Care Centre, Keele University

Principal Investigator: Dr Peter Lindsay, Aireborough Family Practice, Yeadon, Leeds

Risk: Low/Med

Start/End Date: 01/08/14 to 30/11/15

Brief overview of study:

This study aims to find out whether a single steroid injection is effective in treating carpal tunnel syndrome

(CTS) symptoms when compared with a night splint in people suffering with mild to moderate carpal tunnel

syndrome. The study team will analyse the effects of these two treatments over 6 weeks and at 6 months.

Subject to further funding this will also look at whether these 6 weeks of treatment are effective 1 year 2

years later.

The study will take place in up to 50 GP practices and hospital clinics across the UK. Patients aged 18 and

over who have been diagnosed with mild to moderate CTS which has been present for at least 6 weeks will

be eligible for inclusion.

The steroid is a drug called Depo-Medrone. This drug is already widely used to treat CTS. In this study one

injection will be given. The splint is made of elastic and has an aluminium bar which sits on the palm of the

hand. In this study the splint will be worn at night for 6 weeks. Each participant will receive either a single

steroid injection or a splint, and will be asked to complete up to 5 questionnaires over 2 years.

The study is sponsored by Keele University and funded by Arthritis Research UK £508,297 over 3 years and

6 months.

47

Comparing Simulation to Traditional Teaching in Gout Management

Lead Investigator: Dr Anetha Sabanathan, Leadership and Management Fellow, Hull Royal Infirmary

Risk: Low

Start/End Date: 01/09/14 to 01/05/15

Brief overview of study:

The aims of this study are to:

1. Demonstrate that simulation methodology can be used to teach doctors to manage patients with

Gout

2. Compare effectiveness of simulation methodology to traditional teaching methods in the area of

Gout management in four areas:

a. Gain in knowledge acquisition

b. Short term retention of knowledge

c. Long term retention of knowledge

d. Candidate confidence levels

The study team hypothesized that using simulation to teach the management of gout, compared to

traditional lecture base teaching, will lead to better information retention which will result in better long

term patient management.

This is a multicentre study, aiming to include Yorkshire and Humber GP practices, recruiting GPVTS doctors

who have been consented to participate in the study. Participants will be divided into 2 groups: Group A

will have traditional lecture based teaching on Gout Management and Group B will have simulation

teaching on Gout management. GPVTS will only have one of these two teachings and teaching sessions will

take place as part of the usual VTS teaching sessions. Post teaching questionnaires/test will be given –

feedback via Likert scale, standardised questions related to gout management and questionnaires with

standardised questions will be performed pre and post completion of teaching sessions and one month

later (participants will not be informed of when test will occur, but will be asked to complete it at the end

of one of their usual GPVTS study days).

Leeds Osteoarthritis Hip Cohort

Chief Investigator: Professor Philip Conaghan, Professor of Musculoskeletal Medicine, Leeds Institute of

Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds

Other Key Investigators: Dr Gui Tran, Research Fellow, Chapel Allerton Hospital, Leeds; Dr Sarah Kingsbury,

Osteoarthritis Strategic Project Lead, Chapel Allerton Hospital, Leeds

Risk: Low/Med

Start/End Date: 15/09/14 to 17/09/18

48

Brief overview of study:

The principal aim of the study is to describe the complex pathology of hip OA using MRI and compare this

with x-rays and symptoms.

The secondary aims are:

To understand structural progression of hip OA using MRI and the relationship with patient

symptoms

To investigate gait parameters associated with hip OA

To understand progression to OA in people at high risk of developing OA

Consent, and at three points of the study, a questionnaire (including HOOS, OAQol, PAQ-R, HADS and PIPP)

and physical examination will be completed by the participant with a trained investigator at Chapel Allerton

Hospital, a radiographer will complete an MRI scan and a biomechanist will conduct gait analysis at three

points within the study at Chapel Allerton Hospital.

Posters will be placed in GP surgeries, posters and handouts will also be provided to local PPI groups for

distribution.

Participants will be approached in four ways:

1. Identified in LTHT clinics, the study will be outlined to the potential participant by a member of the

healthcare team, if interested the potential participant will be encouraged to discuss with GP, family

and friends.

2. Participants identified as having experienced hip OA through their GP, Musculoskeletal Service or

secondary care records will be sent a letter from their clinician, together with a letter from the PI

outlining the study.

3. Participants will be recruited from previous research projects, who have given consent to be

contacted about future research projects, will be sent a letter of invitation from the PI.

4. Participants telephoning in response to advertising will be asked a series of questions to define

eligibility, if deemed to be eligible they will be sent a PIS and reply slip.

All procedures will take place at Chapel Allerton. The Leeds Musculoskeletal Services and local GPs will be

used as PICs only.

The outcome measure for the study is as a basis for further research, also to assess the strength of

association between a given independent variable and a dependent variable in a regression model.

The Personalised Feedback Model

Chief Investigator: Miss Heather Leggett, PhD Student, University of Leeds

Risk: Low

Start/End Date: 01/12/14 to 13/04/15

CCG Costs/Income: N/A

Status: New study

49

Brief overview of study:

This study aims to address previous research findings of a gap in medical education by developing a model

to aid clinical trainers in providing effective feedback to students on their decision making surrounding

making a diagnosis.

The researcher will name this model the ‘Personalised Feedback Model’ (PFM) – this is to provide a

structured, individualised and focused feedback to medical students on their diagnostic decision making.

The feedback will focus on providing feedback from a self-regulated learning perspective and taking into

account the role of environmental factors.

The researcher will identify how medical students and clinicians are currently provided with/provide

feedback and their perceptions of the usefulness and effectiveness of this feedback, then identify whether

using the model to provide feedback has influenced clinicians feedback provision after reading clinical

scenarios/medical students diagnostic decision making on three paper based cases.

Finally the researcher will identify medical students and clinicians perceptions of the usefulness and

effectiveness of providing feedback in line with the model.

The inclusion criteria are NHS staff who take students from the University of Leeds on placements. The

student must be observed making diagnostic decisions by the participating clinicians. Participants will be

identified as those clinicians who have taken part in previous research have provided their contact details

for further study, the students that they supervise will also have to provide consent to take part. Emails will

be sent to all clinicians who teach 3rd, 4th or 5th year medical students whilst they are on placement, GPs

will also be contacted via email by Dr Michael Scales (who has previous involvement) with PIS and Consent

Form.

The primary outcome measure is whether there is a change in participant’s perceived usefulness and

effectiveness of the feedback they provide or receive and whether feedback in line with the model is

deemed to be useful and effective for future performance. Also whether participant’s method of providing

feedback (clinicians) and diagnostic decision making (medical students) improved after the intervention.

The study is an academic study sponsored by the University of Leeds.

Eurythdia (PIC) (Chronotherapeutic lifestyle intervention for diabetes)

Chief Investigator/Academic Supervisor: Professor Peter Grant, Division of Cardiovascular and Diabetes

Research, The LIGHT Labs, Leeds

Risk: Low

Start/End Date: 01/07/14 – 30/09/16 (start/end dates are estimated at the time of application)

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Brief overview of study:

This is a PIC (participant identification centre) study only.

The principal research question is:

Does evening melatonin treatment have beneficial effects on measures of blood sugar (glucose)

regulation.

The secondary research questions are:

Does evening melatonin treatment have beneficial effects on markers of cardiometabolic risk

factors (blood fats, blood markers of inflammation and blood clotting (thrombosis) and blood

pressure)

Does evening melatonin treatment have beneficial effects on markers of obesity (body weight,

body mass index [BMI], waist circumference)

Does evening melatonin treatment have beneficial effects on genetic markers of circadian rhythm

patterns in white blood cells

Does evening melatonin change an individual’s perception of their quality of sleep and daily

sleeping/waking patterns.

This study aims to recruit 160 relatives of patients with type 2 diabetes mellitus (T2DM), the study will test

whether simple treatments aimed at normalising body clock regulation (supplementing melatonin) can

influence daily and seasonal changes in metabolism and cardiovascular risk factors in relatives of patients

with T2DM.

Participants will be recruited and identified via posters advertising the study distributed within the Manny

Cussins diabetes centre, University of Leeds and in GP Practices in Leeds former PCT, potential participants

will be initially approached by their relatives who will have been provided with information about the study

by their diabetes doctor or nurse.

Fasting blood samples will be collected from all participants (for separation and storage of plasma, serum,

DNA and RNA to enable measurement of markers of body clock and cardiometabolic regulation) Clinical

history, anthropometrics, and demographics will be recorded for each participant. Participants will have an

oral glucose tolerance test, with subsequent blood sampling times at 30, 60, 90 and 120 minutes.

All participants will be asked to fill in questionnaires – Horne Ostberg Morningness/Eveningness

Questionnaire (Chronotype), Pittsburg Sleep Quality Index (Sleep), IPAQ (Physical activity), FINDRISC score

(food questionnaire). All participants will receive general information and advice about healthy lifestyles,

focused on diet and exercise, and benefits of following healthy lifestyle guidelines in relation to prevention

of T2DM.

This study is sponsored by the University of Leeds and funded by the European Framework 7 (€600,000

over 5 years).

51

Gonorrhoea: to screen or not to screen

Chief Investigator/Academic Supervisor: Mrs Jessica Woodburn, Leeds Student Medical Practice

Risk: Low

Start/End Date: 01/01/2015 to 01/05/2015

Brief overview of study:

The aim of this study is to determine the value, in University practices, of screening asymptomatic patients

for gonorrhoea. Gonorrhoea is the second most common sexually transmitted infection found in the UK,

with the prevalence in those aged 18-24 years old being highest. Gonorrhoea can be asymptomatic in up to

50% of people infected with it and research shows that, if undiagnosed, it can go on to cause conditions

such as pelvic inflammatory disease and testicular infection, these can have long term impacts on those

infected with regards ongoing health and fertility. Public Health England is keen that screening for

gonorrhoea should be offered in specialist sexual health clinics, and suggests that where prevalence of

gonorrhoea exceeds 1% of the population, screening should also be introduced in other healthcare settings.

PHE also suggests that where this information is not available or the prevalence of a certain population is

not known, a pilot study should be performed over 3-6 months to determine the value of screening within

that population. By capturing the first six weeks of data from the gonorrhoea screening the study team

aims to evaluate the benefit of additional screening.

Action to support practices implementing research evidence – ASPIRE

Chief Investigator: Professor Robbie Foy, Professor of Primary Care, Academic Unit of Primary Care,

University of Leeds

Risk: Low

Start/End Date: Whole programme 01/07/12 to 30/06/17

CCG Costs/Income: N/A

Status: New study

Brief overview of study:

This research is work package 4 listed below:

Clinical research continually produces new evidence that can reduce patient deaths and enhance quality of

life. Yet such evidence does not reliably find its way into everyday patient care. National Institute for

Health and Clinical Excellence (NICE) guidelines promote treatments of proven benefit and discourage

ineffective interventions. Simply making health professionals aware of best practice seldom works by itself.

Research indicates fairly modest effects of more active approaches (or interventions) to change practice

(e.g. educational meetings, financial rewards). Yet it is difficult to predict with any confidence which

interventions will work best for a given problem and context. It is possible to enhance the effects of

interventions by adapting them to the needs of targeted health professionals.

The programme of research will:

52

1. Involve health professionals and patient representatives in identifying ‘high impact’ recommendations

from NICE guidelines and NHS Quality Standards where a measurable change in clinical practice is

likely to lead to significant patient benefit. (Work Package 1a; WP1a)

2. Analyse anonymised patient data to measure how much typical general practices implement these

high impact recommendations. (WP1b)

3. Develop an intervention package to help general practices implement eight selected high impact

recommendations associated with most scope for improvement. Our intervention will build upon

three commonly used ways of influencing clinical practice: giving professionals feedback data on their

clinical practice, computerised clinical decision support and educational visits to practices. We will

adapt this intervention package for each recommendation.

(WP2a)

4. Test whether the intervention improves patient care for high impact recommendations. This will

involve randomly allocating practices in West Yorkshire to intervention packages and measuring

effects on patient care and value for money. (WP2b)

5. Examine how this approach works and any unintended consequences. (WP2c)

The study is funded by the NIHR Programme Grant and sponsored by the University of Leeds. Total =

£1,996,524

Dementia caregivers' access of information resources (PIC)

Chief Investigator: Dr Sarah Alderson, NIHR Clinical Lecturer, University of Leeds

Other Key Investigators: Miss Amy Tulip (Intercalating BSc student)

Risk: Low

Start/End Date: 11/02/15 to 11/06/15

Brief overview of study:

This study aims to gain an insight into dementia carer’s experiences of accessing information. The study

will ask the following:

1. Where do carers go to find information?

2. When do they seek this information?

3. Why do they access information from a particular source?

The eligibility includes those who are known to be the informal carer of a dementia patient.

Potential participants will be identified by staff members of the Pudsey Integration Team or a GP within

Leeds West CCG and will be given information pack and reply slip (for generic demographic information)

with consent form to complete and send back. Telephone interviews lasting 10-15 minutes will take place

with up to 10 dementia carers; at the beginning of the telephone interview the interviewer will re-iterate

the participant information sheet and consent. The telephone interviews will be conducted from the

University of Leeds. Interviews will be digitally recorded.

53

The outcomes of this study are to allow suggestions to be made as to how clinicians could improve the way

that they provide information to dementia carers, also as part of a BSc student dissertation.

This research is being carried out by intercalating BSc student Amy Tulip based at the University of Leeds,

this is an academic study sponsored by the University of Leeds.

eCRT2 study (Electronic intervention to reduce antibiotic prescribing)

Chief Investigator: Professor Martin Gulliford, Professor of Public Health, King’s College London

Risk: Low

Start/End Date: 01/10/14 to 30/09/17

CCG Costs/Income: N/A

Status: New study

Brief overview of study: The participants for this study will be all General Practices currently registered with participating CPRD

(Clinical Practice Research Datalink). The study asks whether electronically delivered, multi-component

interventions are effective at reducing unnecessary antibiotic prescribing when patients consult for

respiratory tract infections (RTI) in primary care.

Potential participants will first be approached using the trial information pack, comprising the information

sheet and consent form, this will be delivered either by post or email.

There will be two trial arms; control arm practices will continue with usual clinical care, and practices

within the intervention arm will receive complex multi-component interventions, delivered remotely, as

follows: i) feedback of each practice’s antibiotic prescribing results in relation to peers, through monthly

updated antibiotic prescribing reports estimated from CPRD data; ii) delivery of educational and decision

support tools to support policies of no-antibiotic prescribing or delayed prescribing; iii) three-minute

webinars to explain and promote effective utilisation of the intervention materials. The intervention will

last for 12 months.

The outcomes are measured by the rate of antibiotic prescribing for respiratory tract infection per 1,000

participant-years over the 12 month intervention period, also the proportion of acute RTI consultations

with antibiotics prescribed; the consultation rate for respiratory tract infection per 1,000 participant years,

and estimates for each of cough and bronchitis, colds, otitis media, rhino-sinusitis and sore throat.

Evaluations will also be undertaken for total antibiotic prescribing for all indications, diagnostic shifts and

health care utilisation and costs during the intervention period.

All costs for the study will be covered either by the funder or via NIHR service support costs.

54

The study is sponsored by King’s College London and funded by NIHR HTA (Antimicrobial Resistance Cell),

£533,580 over 3 years.

Brexpiprazole in patients with major depressive disorder (PIC)

Chief Investigator: Dr Mark Dale (CEO: MAC Clinical Research)

Risk: Low (PIC)

Start/End Date: 21/05/13-27/11/15 (dates across the UK and EU)

CCG costs/income: N/A

Status: PIC

Brief overview of the study:

The aim of this study is to test whether the addition of brexpiprazole to treatment with a marketed

antidepressant when compared to addition of a placebo (identical-looking inactive drug) can help improve

the symptoms of depression in patients who have not adequately responded to previous treatment with

antidepressants.

Approximately 1400 patients, aged between 18 to 75, will be enrolled onto this study across 12 countries at

100 sites, 5 sites will be in the UK. The study duration is 40 weeks from start of treatment to final follow-up.

Patients will be assigned randomly to receive either brexpiprazole or placebo with a marketed

antidepressant and expected to attend the hospital or research site for screening procedures and then 18

monitoring visits over the course of the 40 weeks

Participants will be identified through databases, colleague referrals or dedicated clinics. Also via

recruitment materials: posters, radio and newspaper advertising. Patients may respond to these online or

by text or telephone.

The study will consist of 18 visits. Each patient will be in the study for 40 weeks. The visits will consist of:

Initial visit to take medical history, complete a questionnaire and determine the patient healthy to

participate.

At the other visits, a number of tests will be carried out:

Questionnaires relating to the patient’s state and their illness, the safety and effectiveness of the

study drug, and quality of life and use of health services. One questionnaire will be completed over

the phone (during a visit to the research site) using an interactive voice response system.

Vital signs will be recorded at each visit and height and weight at some visits.

Urine and blood samples will be taken at some visits.

ECGs will be performed at some visits.

For patients completing the study, the safety follow-up visit will take place 30 days after the last dose of

study treatment and can be a telephone contact unless there is ongoing safety concern. Patients may be

offered an opportunity to participate in an extension study, after completion of this study. If the study

55

doctor considers this appropriate, patients will be provided with a separate information sheet for this

extension study and a decision to participate/not participate can be made at that time.

The study is sponsored and financed by H. Lundbeck A/S. A non-NHS site (MAC) will be the main research

site that PIC participants will be sent to. Costs incurred will be covered by MAC.

56

Appendix Three: ARC Forum Report

Background In England, local healthcare commissioners plan, fund and review health service spending to ensure that

sufficient services are available for the defined populations for whom they are responsible. Until recently,

commissioning departments were located within Primary Care Trusts (PCTs).1 From 1 April 2013, PCTs in

England were abolished and responsibility for commissioning health services moved to newly formed Clinical

Commissioning Groups (CCGs) who will have responsibility for commissioning services for their local

populations.1

Commissioning is a complex process undertaken by individuals from a variety of professional backgrounds and

disciplines, including medicine, public health, nursing, the allied health professions, finance, accounting,

contracting and business studies.2 Compared to PCTs, CCGs were designed to have a higher senior

representation of primary care practitioners at board level, but also have more limited representation of those

with a Public Health background. Public Health support has changed with the specialty moving from the NHS

into local authorities. New CCGs have to recognise the need for a variety of different sources of inputs and

evidence in their commissioning plans and ensure that they have the appropriate mix of advice and support to

allow them to make the best decision for their populations.3

NHS England’s vision for research includes supporting the development of high quality commissioning

underpinned by research evidence and innovation.4 The NHS England strategy also supports the

recommendations of the Strategy for UK life Sciences (2011)5 and Innovation Health and Wealth, accelerating

adoption and diffusion in the NHS (2012).6

57

Our Approach During 2014 Yorkshire and Humber Commissioning Support (YHCS) have delivered a series of themed events in

support of NHS England’s aim to deliver its statutory duties to promote the use of research and the use of

evidence obtained from high quality research. The aim of the events is in line with NHS England’s priority to

the establishment of clear links with clinical leaders across all professions, with academia, industry, and with

non-clinical researchers in health and social care.4

The Applying Research evidence in Commissioning decisions (ARC) forums comprised of eight themed

discussion sessions. The sessions brought together eminent academic researchers, CCG clinical and

commissioning leads, Public Health, pharmacy and broader health community representatives to encourage

collaboration and to promote evidence-based commissioning.

The sessions start with a presentation from a leading academic on a topic of current high priority for CCGs. The

presentation is followed by an interactive discussion led by both a CCG commissioning/clinical lead to provide

their perspective and the presenting academic. Round table discussions and debate then follow supported by

academic facilitators to draw out key implementable evidence for the CCG commissioning and clinical leads to

take away.

The themes chosen for the 2014 ARC forums were decided based on current CCG priorities and the NHS

Outcomes Framework and were as follows: Frailty in Older People and Dementia, Diabetes, Patient Safety,

Mental Health: Adults, Mental Health: Children, Managing Long Term Conditions, End of Life and Palliative

Care and Patient Experience.

58

Hosts, Themes and Keynote Speakers Throughout 2014 the ARC forums were hosted by the following academics / clinicians:

Professor Robbie Foy - Professor of Primary Care at the Leeds Institute of Health Sciences and a GP in

inner-city Leeds: Professor Foy was formerly a Clinical Senior Lecturer (Newcastle University) and an

MRC Training Fellow in health services research (Universities of Edinburgh and Aberdeen). Professor Foy

trained as a public health physician; was a 2006/7 Harkness/Health Foundation Fellow in Health Care

Policy; is Deputy Editor-in-Chief of the open access journal, Implementation Science and is a member of

the NICE Implementation Strategy Group.

Dr Judith Parker - Deputy Clinical Leader, Greater Huddersfield Clinical Commissioning Group: Dr

Parker became a full-time GP principle in 1989 in the Lindley Practice; has been a Chair of the Medical

Audit Advisory Group (MAAG); developed clinical governance for the Primary Care Group (PCG); chairs

the Diabetes and Coronary Heart Disease (CHD) Network meetings; has helped to develop community

eye screening and podiatry services; is the corporate and clinical governance lead and vice chair for the

CCG, and chairs the CCG Quality & Safety Committee.

Professor Allan House - Professor of Liaison Psychiatry in the Academic Unit of Psychiatry and

Behavioural Sciences at the University of Leeds: From 2005 to September 2013 Professor House was

the Director of the Leeds Institute of Health Sciences. Professor House chairs the Yorkshire and Humber

Research Funding Committee of the National Institute for Health Research's Research for Patient Benefit

programme. Professor House served as a member of the HTA Commissioning Board and is a member of

the NIHR Panel of Experts.

Professor Rebecca Lawton - Professor of Psychology of Healthcare at the University of Leeds: Professor

Lawton holds a joint post at the Bradford Institute for Health Research where she leads the multi-

disciplinary patient safety research team. Professor Lawton has been working in the field of patient

safety research since 1994 and leads the ‘Evidence based transformation with the NHS’ Collaboration for

Leadership in Applied Health Research and Care (CLAHRC) theme for Yorkshire and Humber.

Professor Carl Thompson – Professor, the Department of Health Sciences at the University of York:

Professor Thompson was awarded a personal Chair at York in 2009 and is a social scientist and nurse by

background. With more than £14m in research funding (as PI or co-applicant) from the ESRC, the MRC,

NHS Research & Development and the National Institute for Health Research, his work focuses on the

role of decision making and judgement as a backdrop for the implementation of research findings and

quality improvement in health services.

59

Frailty in Older People and Dementia – 29 January 2014

Host: Professor Robbie Foy

Keynote Speakers: Professor Murna Downs and Dr Andrew Clegg

Older patients have an increased chance of developing long term medical conditions, frailty, dementia and

disabilities and there is also an increased risk of older patients becoming socially isolated. As most patients

over the age of 75 have a number of conditions at once, there is a demand for coordinated, person-centred

care, and there is a need for the unique challenge of frailty to be acknowledged and confronted. 7 Three West

Yorkshire CCGs have identified dementia and one care for older people as key priorities for 2014/15.

This inaugural meeting was hosted by Professor Robbie Foy. The keynote speeches were delivered by

Professor Murna Downs, Professor in Dementia Studies and Head of the Bradford Dementia Group at the

University of Bradford, and Dr Andrew Clegg, Senior Lecturer in the Academic Unit of Elderly Care &

Rehabilitation at the University of Leeds and Honorary Consultant Geriatrician at Bradford Teaching Hospitals

NHS Foundation Trust.

Professor Downs’s presentation was entitled ‘Dementia care and services and the research implications for

commissioning’ with a particular emphasis on improving diagnosis and post-diagnostic support. Dr Clegg spoke

about ‘Frailty in Older People: A Clinical and Research Perspective’ which outlined how care for older people

with frailty could be improved.

Diabetes - 27 February 2014

Hosts: Dr Judith Parker and Professor Allan House

Keynote Speaker: Dr Ramzi Ajjan

Diabetes is a growing global health burden. The International Diabetes Federation estimates that 387 million

people have diabetes and this is expected to rise to 592 million by 2035.8 Diabetes has been identified by

three West Yorkshire CCGs as a key priority for 2014/15.

Professor Allan House hosted this forum and Dr Ramzi Ajjan provided the keynote speech. Dr Ajjan is an

Associate Professor and Consultant in Diabetes and Endocrinology at the Leeds Institute of Genetics, Health

and Therapeutics within the Division of Cardiovascular and Diabetes Research. Dr Ajjan’s programme of work

spans basic, translational and clinical studies with the collective aim of improving clinical outcome in

individuals with diabetes.

Dr Ajjan’s presented ‘Decisions in Diabetes’. His talk put an emphasis on the importance of improving the

integration between primary and secondary care to improve patient outcomes and glycaemic control.

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Patient Safety – 1 May 2014

Hosts: Dr Judith Parker and Professor Rebecca Lawton

Keynote Speaker: Professor Rebecca Lawton

As two percent of all general practice consultations result in a patient safety incident, 9 patient safety is a hot

topic and has been identified by two West Yorkshire CCGs as a key priority for 2014/15.

This forum was co-hosted by Professor Rebecca Lawton and Dr Judith Parker, with Professor Lawton providing

the keynote speech. Professor Lawton’s presentation was centred on existing evidence based solutions and

tried and tested approaches. Locally this has been the Training and Action for Patient Safety (TAPS)10

programme which has helped multi-professional clinical teams in acute trusts to develop innovative solutions

to address common patient safety problems such as: handover, medicines safety, suicide prevention, venous

thromboembolism assessment and management, patient transfer and falls.

Professor Lawton and colleagues from the NHS Improvement academy have also been delivering the Achieving

Behaviour Change (ABC)11 for patient safety training programme across the region. Delegates are introduced

to behaviour change theory and then, using the example of promoting safe nasogastric tube practice, are

taken through a series of steps to understand barriers to behaviour change and develop tailored interventions.

Mental Health: Adults – 25 June 2014

Host: Professor Robbie Foy

Keynote Speaker: Professor Simon Gilbody

Six West Yorkshire CCGs have identified mental health as a key priority for 2014/15. The broad economic case

for supporting improvements to mental health services include: ‘distress and disability (90 percent of societal

cost from depression has been found to be result of unemployment and absenteeism); enduring impacts (early

intervention for young people experiencing a psychotic episode has been found to save £15 over 10 years for

every £1 invested); co-morbidities (those with mental ill-health are more likely to suffer from a number of

physical ailments, close links between co-morbidities and deprivation); antisocial behaviour and crime; suicide

and self-harm (the cost of a completed suicide of a working age individual in the UK has been estimated at

£1.6m); and stigma and discrimination.’12

The keynote speech for this forum was delivered by Professor Simon Gilbody, Professor of Psychological

Medicine and Health Services Research at the University of York. Professor Gilbody’s presentation explored

the relationship between smoking and severe mental ill health, referencing the project SCIMITAR (Smoking

Cessation in Mental Ill Health Trial).

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Mental Health: Children – 17 July 2014

Host: Professor Robbie Foy

Keynote Speaker: Professor David Cottrell

Research has shown that ten percent of children and young people aged five to fifteen have a clinically

diagnosable mental disorder.13 The keynote speech for this forum was delivered by Professor David Cottrell, a

Professor of Child & Adolescent Psychiatry at the University of Leeds. Professor Cottrell is a co-author of the

NICE guidelines on management of depression in children and young people and is Chief Investigator of a large

multi-centred randomised controlled trial of systemic family therapy following teenage self-harm funded by

the NIHR. He is also co-investigator on a second large multi-centred randomised controlled trial evaluating

multi-systemic treatment for teenagers at risk of care or custody, funded by the Department of Health.

Professor Cottrell’s presentation, ‘The evidence base for treatment interventions in CAMHS: a commissioners’

guide’, advised that more than a third of adults with mental health problems first experience these during

childhood, and explored the evidence base for treatment interventions in Child and Adolescent Mental Health

Services (CAMHS).

Managing Long Term Conditions – 24 September 2014

Host: Professor Robbie Foy

Keynote Speakers: Professor Allan House and Dr Brendan Kennedy

Ten West Yorkshire CCGs have identified long term conditions as a key priority for 2014/15. The burden of long

term conditions on resources within the NHS is increasing. It is estimated that over fifteen million people in

England have a long term condition; people with long term conditions use a significant proportion of health

care services, and their care absorbs seventy percent of hospital and primary care budgets in England.14 Long

term conditions can affect many aspects of a person’s life.

Professor Allan House presented ‘Problems with living with chronic illness: understanding what goes wrong as

a prelude to commissioning and delivering better services’, which explored supported self-management and

focused on a model for coping with long term conditions.

Dr Brendan Kennedy is a GP and an Airedale, Wharfedale and Craven CCG board member, and he presented

‘Meeting the mental health needs of people with long term conditions in primary care’. Dr Kennedy shared

learning from a project undertaken in his practice which explored mental health as a long term condition.

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End of Life and Palliative Care – 16 October 2014

Host: Professor Carl Thompson

Keynote Speaker: Professor Mike Bennett

Around half a million people die every year in England and two thirds of these are people over 75; the majority

of these deaths come after a period of long term illness such as cancer, dementia or heart disease.15 In June

2014 five new Priorities for Care, created by the Leadership Alliance for the Care of Dying People, were

introduced in response to the review of the Liverpool Care Pathway. This new approach was outlined in the

publication ‘One Chance to Get it Right’ as the basis for caring for someone at the end of their life, with a focus

on ensuring that care is tailored to the individual and delivered compassionately and respectfully.16

The penultimate forum of the year was hosted by Professor Carl Thompson and the keynote speech for the

forum was presented by Professor Mike Bennett, the St Gemma’s Professor of Palliative Medicine and the

Director of the Academic Unit of Palliative Care at Leeds University. Professor Bennett presented ‘Research

based commissioning for palliative and end of life care’, proposing that there is a need to engage with patients

about palliative and end of life care prior to the final weeks or days of their lives. Professor Bennett suggested

that commissioning earlier discrete palliative interventions could be a realistic way of improving the quality of

palliative care for patients.

Patient Experience – 12 November 2014

Host: Professor Robbie Foy

Keynote Speakers: Dr Jess Drinkwater and Dr Kate Hill

NHS England’s Five Year Forward View states ‘The definition of quality in health care, enshrined in law,

includes three key aspects: patient safety, clinical effectiveness and patient experience. A high quality health

service exhibits all three.’17 The final forum of 2014 was hosted by Professor Robbie Foy and was attended by

both CCG leads and representatives from patient participant groups.

Dr Jess Drinkwater is an NIHR In-practice fellow; she works as a GP in Bradford and as a researcher at the

University of Leeds, where she has been investigating patient and public involvement in primary care. Dr

Drinkwater presented early results of her work observing different GP Patient Participation Groups and CCG

patient groups, wherein she has conducted interviews with patients, GPs, practice managers and engagement

leads.

Dr Kate Hill is an applied health researcher. She was appointed to her current role as Senior Research Fellow at

Leeds University in September 2009. Dr Hill presented ‘Developing resources to support patient and public

involvement in health research and care’, sharing learning from a project which had aimed to develop a tool to

increase patient participation in research.

63

Attendance The ARC forums were held in both Wakefield and Brighouse, alternating between the two locations; these

were judged to be the most accessible areas for the majority of West Yorkshire commissioners.

Figure 1 shows the total number of delegates from West Yorkshire CCGs who registered to attend the ARC

forums throughout 2014, as well as the number of delegates who attended from other organisations, inclusive

of representatives from South Yorkshire CCGs, public health, members of patient participation groups and

representatives from YHCS (exclusive of the YHCS Research team).

Figure 1 – Number of delegates registered to attend the 2014 ARC forums

The number of delegates who registered to attend the ARC forums that focused on Patient Safety and Frailty

in Older People and Dementia spanned the largest geographical area, with nine West Yorkshire CCGs

registering interest in attending these forums.

The Diabetes ARC forum had the most public health representation, with delegates from Bradford Council,

Kirklees Council and Wakefield Council contributing the public health perspective to round table discussions.

The Patient Experience ARC forum had representatives attend from both the Wakefield Diabetic Group and

the Castleford Cancer Group, offering the perspective of patients actively involved in participation groups.

13

10

17

6

8

5

13

8

0

7

4 5

2

6

1

6

0

2

4

6

8

10

12

14

16

18

Frailty andDementia

Diabetes PatientSafety

MentalHealth -Adults

MentalHealth -Children

Long TermConditions

End of LifeCare

PatientExperience

WY CCG

Other

64

48%

51%

1%

Strongly agree

Agree

Disagree

Strongly disagree

Ratings and Feedback YHCS is keen to facilitate the development of research that addresses local and national commissioning

priorities. We work, on behalf of all the Yorkshire and Humber CCGs, with a host of academic and NHS

organisations to deliver this vision. The ARC forums aim to bring together prominent academic researchers and

CCG leads to encourage collaboration and to promote evidence-based commissioning. As such the

contribution of attendees and CCG colleagues will help to shape the future content and structure of the

forums.

YHCS requested feedback at the end of each ARC forum. Figures 2-5 show the total responses received

throughout 2014 when attendees were asked whether they strongly agreed, agreed, disagreed or strongly

disagreed with the following statements:

The content was relevant to your role and responsibilities

The content was important for your job role

The content was delivered in a manner that you understood

You would recommend to others

Figure 2 shows that 100% of attendees who provided feedback following the ARC forums either agreed or

strongly agreed that they would recommend the session to others, with 99% agreeing or strongly agreeing

that the content was relevant to their responsibilities and roles.

Figure 2 - The content was relevant to your role and responsibilities

65

60%

40% Strongly agree

Agree

Disagree

Strongly disagree

Figure 3 - The content was important for your job role

Figure 4 - The content was delivered in a manner that you understood

Figure 5 - You would recommend to others

46%

49%

5%

Strongly agree

Agree

Disagree

Strongly disagree

65%

34%

1%

Strongly agree

Agree

Disagree

Strongly disagree

66

Figure 6 demonstrates, per forum, the responses received when asked whether the session content was mainly:

New information, knowledge and/or skills

Knowledge and/or skills I have previously learned but this discussion helped me to see for the first time how it was applied to my role

Covering information, knowledge and/or skills I already know and have well developed Figure 6. The content of the forum was mainly:

In total 71% of delegates fed back that the content delivered at the forum provided them with new

information, knowledge and/or skills, or explored knowledge and/or skills that they already had but developed

this to a point where they could now see, for the first time, how the knowledge and skills learned were

applicable to their roles.

Attendees were asked for their overall rating of the forum. Figure 7 shows that, of those delegates who

provided feedback, 91% of attendees rated their experience of the forum overall as being either good or

excellent.

3

4 4

1

5

3 3

1

5

6

4 4

3 3 3 3

2

4

7

0

1

2

0

7

0

1

2

3

4

5

6

7

8

New information, knowledgeand/or skills

Knowledge previously learned butnow see how this applies to myrole for the first time

Covering information I alreadyknow and have well developed

67

Figure 7 – Overall rating of the ARC forums 2014

At the end of each forum attendees were asked what they had learned and what changes they would make in

practice as a result of the forum. Responses included:

Frailty in Older People & Dementia

Try to work closer with clinical/academic experts when conducting evaluations - particularly of

complex and comorbid social conditions.

Use evidence to support business cases, commissioning decisions, development of CQUINS, quality

indicators and service developments.

Think about the use and content of MDT meetings. Thought-provoking about patient stories regarding

dementia.

Looking at shared decision-making resources to improve practice.

Increased value placed in MDT, individualised care planning.

Look at some of the research information suggested.

Diabetes

Ways of looking for evidence to improve practice. Understanding what evidence is useful to practice.

Tailor diabetic care for each patient - consider tailored education for ethnic minorities.

Continue with structure re-design.

Explore research results and discuss with network and service redesign working group.

Pinch with pride ideas from other CCGs areas of good practice.

Think more about what the research says when planning projects/service redesign.

Networking always useful and sharing ideas.

Review audit checklist and BP target at my practice.

Think more carefully about AC target, cholesterol, BP.

Discuss with diabetes lead re: service redesign, engaging patients and using models that work.

Very useful in listening to experiences and ideas from other areas.

Improved networking with colleagues across the region.

45%

46%

9%

Excellent

Good

Satisfactory

Unsatisfactory

68

Patient Safety

Find out more re: PRASE, ABC etc.

Interested to investigate patient perceptions of safety in primary care.

Share errors.

Try to tap into PRASE in new pathway implementation.

Look at prescribing systems and ensure alerts appropriate to ensure they are viewed, not ignored.

Culture of openness promotion.

Report at least one patient safety incident. Patient feedback. Share good practice.

Reappraise myself with recent studies.

Further engagement with the CSU.

Mental Health: Adults

Email GPs re: evidence. Consider CQUIN re: care trust re: staff and patient smoking cessation.

Highlight this aspect in future MH/health inequalities discussions.

Discussion with other commissioners re: smoking cessation - possible CQUIN.

I will make links with the PH commissioner responsible for smoking cessation services.

Mental Health: Children

I will disseminate the Kirklees CYP survey results more widely as there seemed to be a feeling this

would be useful.

Ensure specs for commissioning are well highlighted. Using evidence as lever to protect services

funding.

I have more evidence to take back to my CCG. I hope this will give me a better ability to make change.

I learnt a lot about alternative ways of helping young people with mental health issues.

Strengthens motivation to support our system’s issues with commissioning CAMHS.

Make use of evidence base, more confidence.

I feel I now have really good evidence to take back to my commissioning colleagues to try and drive

forward this issue.

Ensuring robust service specification.

Managing Long Term Conditions

Helpful in thinking through next steps with current project and its evaluation.

A lot of learning around wellbeing issues within LTC management from a commissioning perspective.

Helpful to frame areas of work with the mental health perspective - some queries to take back to

colleagues about how our activities are moving (if indeed they are) from provision of information into

actions around barriers.

Remembering to find out what the patient thinks and feels about their illness. Using this to plan and

design interventions.

Reinforced some ideas around co-production, particularly using this approach in small projects which

could then be expanded if successful, or learnt from if not.

69

Consider how mental health can be de-stigmatised. Look again at how IAPT and RAID work /

outcomes.

Share wider in CCG with quality/transformation teams.

Reflection on Allan's project. Stop framing into Anxiety + Depression etc.

End of Life and Palliative Care

Further discussion with acute trusts regarding earlier referral to palliative care.

Need to look at more information and data to support commissioning decisions.

More informed approach.

Look to drive better integrated care from secondary care consultants and palliative care consultants.

Look at deaths less than 25/7 from last chemo. Audit of early and delayed deaths after admission -

where are the obstacles to good care?

Patient Experience

Appointment system to be comprehensively explained to service users and the consequences of

missing appointments. More patient awareness of services.

Outcomes based service provision. Maintaining feedback during processes when using engagement.

Keep up to date with developments in the evidence as to what 'good practice' may be.

I'll feedback to the primary care improvement team and patient engagement team. Will be more

confident in ensuring patient needs outcomes are considered in commissioning.

Considering the focus of conversations and whether these need to be stratified according to the

membership of the group.

As a member of a local PPG I can feed back to them.

A refresher and prompt - always healthy to reflect on how you are putting theory into practice. The

PPF questions were helpful.

The presentation and document sheet provided by Jess Drinkwater was fantastic and really focused

my thinking and action.

I will be looking to see how we work with the PPGs and using an understanding of different roles can

help to build on strengths so that the 'sum is greater than the whole'.

70

References 1 Department of Health (2010) Equity and excellence: liberating the NHS. Department of Health.

2 Smith J, Dixon J, Maya N, et al. (200%) Practice based commissioning: applying the research

evidence. BMJ, 331:1397–9.

3 Clarke A, et al (2013) Evidence-based commissioning in the English NHS: who uses which

sources of evidence? BMJ Open 3:e002714 doi:10.1136/bmjopen-2013-002714

4 NHS England (2013) Research and Development Strategy 2013-18: Research is everybody’s

business. NHS England.

5 Department for Business Innovation and Skills; Office for Life Sciences (2011) Strategy for UK Life

Sciences. Department of Health.

6 Department of Health (2012) Innovation Health and Wealth: accelerating adoption and diffusion in

the NHS. Department of Health.

7 NHS England (2014) Safe, compassionate care for frail older people using an integrated care pathway:

Practical guidance for commissioners, providers and nursing, medical and allied health professional

leaders. NHS England.

8 The International Diabetes Federation (2014) Key findings 2014. International Diabetes Federation.

9 Gaal, S., Verstappen, W., & Wensing, M. (2011). What do primary care physicians and researchers

consider the most important patient safety improvement strategies? BMC health services

research, 11(1), 102.

10 Slater, B. L., Lawton, R., Armitage, G., Bibby, J., & Wright, J. (2012). Training and action for

patient safety: embedding interprofessional education for patient safety within an improvement

methodology. Journal of Continuing Education in the Health Professions, 32(2), 80-89.

11 Taylor, N., Lawton, R., Slater, B., & Foy, R. (2013). The demonstration of a theory-based approach to

the design of localized patient safety interventions. Implementation Science, 8(1), 123.

12 Davies, S. (2014) Chief Medical Officer (CMO) annual report: public mental health. Department of

Health.

13 Office for National Statistics (2004) British Child and Adolescent Mental Health Surveys. Department of

Health.

14 Department of Health (2013) Improving quality of life for people with long term conditions.

Department of Health.

15 Department of Health (2013) Improving care for people at the end of their life. Department of

Health.

16 Leadership Alliance for the Care of Dying People (2014) One Chance to Get It Right: Improving people’s

experience of care in the last few days and hours of life. Leadership Alliance for the Care of Dying

People

17 NHS England (2014) Five Year Forward View. NHS England.

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Appendix Four: Understanding prescribing of opioids for chronic non-cancer pain in general practice

In order to better understand the patterns and trends in long term prescribing of opioids in general practice,

the study team undertook a retrospective analysis of computerised patient records from general practices in

Leeds and Bradford. They recruited 124 (79%) out of the 157 general practices that used the SystmOne

patient record (out of a total of 195 practices). They searched for patients who had received a prescription for

an opioid between April 2005 and March 2012. From that search, they compared patients who had received

four or more opioid prescriptions in a 12-month period with those that had received less than four to give a

comparison of long-term (chronic) use with acute use. They also defined opioids as either strong or weak, to

allow comparison between users of the two types.

After examining temporal trends, the team analysed the data solely from the Quality and Outcome

Framework (QOF) year 2011-12 for 111 general practices and for all patients who had been prescribed an

opioid in that period. This avoided selection bias through the inclusion of individuals multiple times as

separate events if all years were included. The two key aspects, ever long-term and ever strong, were

analysed with two logistic regression models. Factors and covariates were discussed and parsimonious models

were sought including patient demographics and characteristics, service use, and practice characteristics.

Practice characteristics were strongly correlated with each other with the number of GPs increasing with the

list size and QOF points awarded. Practice IMD score was also included in the model. Partly for simplicity of

interpretation, and concerns over nonlinearity, all covariates were discretised. In particular, IMD was divided

into thirds as was patient age. Although this discretisation creates unnecessary measurement error, it is

compensated by the greater ease of interpretation.

After excluding known cancer cases, the team found that opioid prescribing increased markedly from 2005 to

2012. The ratio of strong to weak opioids prescribed also rose. Long term prescribing was associated with a

range of patient factors including being an older female, recorded mental illness, smoking, polypharmacy, and

pain clinic referrals. A similar pattern emerged for strong opioids although young males are more likely to

have them prescribed. They found marked variation in prescribing levels between general practices which was

incompletely explained by patient factors and population deprivation.

Whilst the study cannot establish causation for the observed patterns, some of the associations found should

alert clinicians to patient characteristics associated with opioid prescribing and its risks. However, much

unexplained variation may be related to differences in approaches to managing prescribing amongst general

practices. This suggests that opioid prescribing should be a key target for future quality improvement

initiatives targeting general practice.

The study team also sought to understand the mechanisms that maintained or escalated opioid prescribing in

general practice. They used qualitative methods to explore the experiences, beliefs and expectations of

patients and GPs.

The researchers contacted practices which had agreed to share data for Objective 1; 37 (23%) practices

expressed an interest in participating in the qualitative study. Practice staff searched electronic patient

72

records to identify patients aged 18 and over currently recorded with repeat prescriptions for either a strong

opioid (e.g. morphine) or a weak opioid (e.g. codeine). Of these, we also identified those with and without a

mental illness Read Code. They excluded patients with a diagnosis of cancer and/or indicators of cognitive

impairment (e.g. memory problems). Each practice invited up to 60 patients by letter to contact the study

team if they were interested. Where responses exceeded this quote, 60 patients were randomly selected by

NHS number. As recruitment progressed, the team sought to maximise the diversity of the sample according

to gender, age, recency of significant changes in opioid prescriptions, opioid strength and ethnicity. They

invited GPs in from all practices which had shared data for Objective 1 to take part in one of two focus groups

to be held within their locality.

Individual in-depth interviews were undertaken with 23 patients then prescribed long-term opioids and two

focus groups were conducted with 15 GPs from Leeds and Bradford, UK. The researchers analysed audio-

recorded transcripts from interviews and focus groups using constant comparative analysis, delineating

shared and contrasting perspectives on the management of chronic pain and opioid prescribing.

Long-term opioid prescribing could be understood through patient and GP characteristics that influenced

clinical transactions. Patients were driven by the need for explanation, pain relief and to improve or maintain

quality of life. Responses to these needs appeared to be influenced by patient levels of distress and their

thoughts about the pain, about their GP, about what would happen in the future and about where

responsibility for change resided. Clinicians varied in how they understood, or were interested in, chronic

pain especially when the medical diagnosis or expectations of treatment were uncertain. They had varying

negotiating styles, psychological skills and interest in dealing with distress or in managing conditions where

their own approach is at odds with the patient’s wishes.

These factors influenced four characteristics of clinical transactions, and thereby prescribing decisions: where

perceived control resided and who had the ability to make change; the sense of continuity in the relationship,

which influenced the drive for stability or change; clarity of strategy, including the degree to which long term

planning was subverted by reactions to the immediate content of consultations and; the sense of trust and

mutuality, the degree to which the question of pain management became a vehicle for negotiating and

resolving wider aspects of the relationship.

Both patients and doctors struggled with chronic pain and its treatment. As well as alleviation of pain and

distress, patients seek explanations and continuity within trusting relationships. Doctors recognised their own

discomfort in feeling unable to treat problems underpinning pain, identify a sufficient range of options to treat

pain, and negotiate clear management plans. Findings suggest that reversal of the continuing rise in opioid

prescribing needs to include three main targets: patient expectations; doctors’ beliefs and abilities and;

practice systems for managing complex conditions and prescribing.