Heart Surgery PSP Protocol


Published: 24 February 2020

Version: 2.0

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Purpose of the PSP and background

The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Heart Surgery Priority Setting Partnership (PSP) and the basic roles and responsibilities of the partners therein. It is recommended that the Protocol is reviewed by the Steering Group and updated on at least a quarterly basis.

The James Lind Alliance (JLA) is a non-profit making initiative, established in 2004.  It brings patients, carers and clinicians together in Priority Setting Partnerships (PSPs).  These partnerships identify and prioritise uncertainties, or ‘unanswered questions’, about the effects of treatments that they agree are the most important.  The aim of this is to help ensure that those who fund health research are aware of what really matters to both patients and clinicians.  The National Institute for Health and Care Research (NIHR – www.nihr.ac.uk) funds the infrastructure of the JLA to oversee the processes for priority setting partnerships, based at the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), University of Southampton.  

The Heart Surgery PSP was established following a British Heart Foundation sponsored workshop held on the 13th February 2017 that aimed to develop a national research strategy in cardiovascular surgery. The workshop considered strategies to establish industrial/ researcher collaborations, clinical trials networks, research collaboratives, and increases in the opportunities for young surgeons who wish to undertake research during their career. The main conclusion of the workshop was that an agreed set of research priorities, developed through a transparent process of consultation and stakeholder engagement, would be welcomed by the British Heart Foundation, as well as other funders of research into cardiovascular disease. 

Aims and objectives of the Heart Surgery PSP

The aim of the Heart Surgery PSP is to identify the unanswered questions about cardiac surgery treatment from patient and clinical perspectives and then prioritise those that patients and clinicians agree are the most important. 

The objectives of the Heart Surgery PSP are to:

  • work with patients, carers, and clinicians to identify uncertainties about the cardiac surgery care pathway. These will include:
    • Acquired cardiovascular diseases as well as common diseases affecting the thoracic aorta and congenital diseases limited to the aortic (bicuspid) valve in adults
    • The indications for cardiac surgery versus other treatments, including medical treatments, or interventional cardiology and other less invasive treatments.
    • The accuracy and effectiveness of tests used as diagnostic tools or for risk stratification in patients considered for cardiac surgery.
    • Perioperative care, including pre-surgery optimisation, anaesthesia and intraoperative care, and post-surgical care.
    • Patient centred and longer-term outcomes in cardiovascular surgery.
    • The use of extracorporeal membrane oxygenation or heart assist devices used as adjuncts to adult cardiovascular surgery but not acute lung injury, or as bridge to destination therapy for heart failure.
  • to agree by consensus a prioritised list of those uncertainties, for research.
  • to publicise the results of the PSP and process.
  • to take the results to research commissioning bodies to be considered for funding.

The Steering Group

Patient and family member/carer representative/s:

  • Anthony Locke, Leicester Cardiac Surgery Patient and Public Involvement Group, NIHR Senior PPI panel
  • Peter Read, Cardiac Surgery Research PPI
  • Trevor Fernandes, Cardiovascular Care Partnership (CCPUK) and Wider Community Patient Links
  • Richard Fitzgerald, Cardiovascular Care Partnership (CCPUK) and Wider Community Patient Links
  • Zena Jones, patient representative, Health Watch County Durham
  • Jonathan Stretton-Downes, Six Times Open
  • Grace Stretton-Downes, family member representative
  • Michael Flude, TakeHeart (Derby)

Clinical representative/s:

  • Professor Gavin Murphy, BHF Chair of Cardiac Surgery, University of Leicester, Society for Cardiothoracic Surgery in Great Britain and Ireland, Academic and Research Committee Chair
  • Mr Graham Cooper, President, Society for Cardiothoracic Surgery in Great Britain and Ireland
  • Mr Enoch Akowuah, Consultant Cardiac Surgeon, James Cook Hospital, Middlesbrough, member of the British Cardiac Society, Heart Valve Clinical Studies Group
  • Professor Mahmoud Loubani, Hon Professor of Cardiothoracic Surgery, University of Hull
  • Mr David Jenkins, Consultant Cardiac Surgeon, Papworth Hospital Cambridge
  • Dr Julie Sanders, Director Clinical Research, Quality and Innovation, St Bartholomew’s Hospital
  • Professor John Pepper, Professor of Cardiothoracic Surgery, Imperial College London
  • Dr Andrew Klein, Association of Cardiothoracic Anaesthesia Research Subcommittee Chair
  • Professor Rod Stables, British Cardiovascular Society, Academic and Research Committee Chair
  • Carol Akroyd, East Midlands Centre for BME Health & CLAHRC Prevention Theme Manager
  • Harpal Ghattoraya, Research Delivery Manager (Divisions 2 & 5), NIHR Clinical Research Network (CRN)
  • Mr Peter Braidley, Heart Research UK Trustee
  • Professor Stephen Clark, Professor of Cardiothoracic Surgery & Cardiopulmonary Transplantation Freeman Hospital, Newcastle
  • Dr Nazish Khan, Principal Pharmacist Cardiac Services, The Royal Wolverhampton Hospitals NHS Trust 

The Partnership and the priority setting process will be supported and guided by:

  • The James Lind Alliance (JLA) - Katherine Cowan (PSP Chair, JLA Senior Adviser)

Professor Gavin Murphy and project team University of Leicester

  • Tracy Kumar, Senior Research Manager
  • Sue Page, PA to Professor Gavin Murphy
  • Hardeep Aujla, Clinical Trial Co-ordinator
  • Bethany Tabberer, Clinical Trials Administrator
  • Florence Lai, Statistician
  • Clare Gillies, Lecturer in Health Statistics
  • Selina Lock, Research Information Advisor 

The Steering Group will agree the resources, including time and expertise that they will be able to contribute to each stage of the process. The JLA will advise on this.

The wider Partners

Organisations and individuals will be invited to be involved with the PSP as partners.  Partners are groups or individuals who will commit to supporting the PSP by disseminating the PSP survey and helping the PSP to gather questions and uncertainties of practical clinical importance relating to the treatment and management of the health problem in question.  Partners represent the following groups:

  • adults who have had cardiac surgery
  • carers of people who have had cardiac surgery
  • medical doctors, nurses and professionals allied to medicine with clinical experience of heart surgery.

It is important that all organisations which can reach and advocate for these groups should be invited to become involved in the PSP. The JLA Adviser will take responsibility for ensuring the various stakeholder groups are able to contribute equally to the process.

Exclusion criteria

Some organisations may be judged by the JLA or the Steering Group to have conflicts of interest. These may be perceived to adversely affect those organisations’ views, causing unacceptable bias. As this is likely to affect the ultimate findings of the PSP, those organisations will not be invited to participate. It is possible, however, that interested parties may participate in a purely observational capacity when the Steering Group considers it may be helpful.

The methods the PSP will use

This section describes a schedule of proposed stages through which the PSP aims to fulfil its objectives. The process is iterative and dependent on the active participation and contribution of different groups. The methods adopted in any stage will be agreed through consultation between the Steering Group members, guided by the PSP’s aims and objectives. More details can be found in the Guidebook section of the JLA website at www.jla.nihr.ac.uk where examples of the work of other JLA PSPs can also be seen. 

Step 1: Identification and invitation of potential partners

Potential partner organisations will be identified through a process of peer knowledge and consultation, through the Steering Group members’ networks. Potential partners will be contacted and informed of the establishment and aims of the Heart Surgery PSP and may be invited to attend and participate in an initial stakeholder meeting if this is being arranged. 

Step 2: Initial stakeholder meeting / awareness raising 

The initial stakeholder meeting / awareness raising will have several key objectives:

  • to welcome and introduce potential members of the Heart Surgery PSP
  • to present the proposed plan for the PSP
  • to initiate discussion, answer questions and address concerns
  • to identify those potential partner organisations which will commit to the PSP and identify individuals who will be those organisations’ representatives and the PSP’s principal contacts
  • to establish principles upon which an open, inclusive and transparent mechanism can be based for contributing to, reporting and recording the work and progress of the PSP.

Step 3: Identifying treatment uncertainties

Each partner will identify a method for soliciting from its member’s questions and uncertainties of practical clinical importance relating to the treatment and management of Heart Surgery. A period of three months will be given to complete this exercise.

The methods may be designed according to the nature and membership of each organisation, but must be as transparent, inclusive and representative as practicable. Methods may include membership meetings, email consultation, postal or web-based questionnaires, internet message boards and focus group work.

Existing sources of information about treatment uncertainties for patients and clinicians will be searched. These can include question-answering services for patients and carers and for clinicians; research recommendations in systematic reviews and clinical guidelines; protocols for systematic reviews being prepared and registers of ongoing research.

The starting point for identifying sources of uncertainties and research recommendations is NHS Evidence: www.evidence.nhs.uk

Sources of uncertainties for research recommendations may include:

  • Cochrane database
  • NHS Evidence
  • NICE Guidance and NICE Research recommendations database
  • BMJ clinical evidence
  • Relevant treatment guidelines as published by the American College of Cardiology, the European Society of Cardiology, the European Association of Cardiothoracic Surgery, the American Association of Thoracic Surgeons, and the American Heart Association.

In consultation with the Steering Group, the JLA will commission an information specialist with appropriate skills and knowledge to carry out this piece of work, and to manage the process of refining the survey data, as described in the next section.

Step 4: Refining questions and uncertainties

The Steering Group will need to have agreed exactly who will be responsible for this stage – the JLA can advise on the amount of time likely to be required for its execution. The JLA will participate in this process as an observer, to ensure accountability and transparency.

The consultation process will produce “raw” unanswered questions about diagnosis and the effects of treatments. These raw questions will be assembled and categorised and refined by the appointed information specialist into “collated indicative questions” which are clear, addressable by research and understandable to all. Similar or duplicate questions will be combined where appropriate.

Systematic reviews and guidelines will be identified and checked by the appointed information specialist to see to what extent these refined questions have, or have not, been answered by previous research. Sometimes, uncertainties are expressed that can in fact be resolved with reference to existing research evidence – i.e. they are "unrecognised knowns" and not uncertainties. If a question about treatment effects can be answered with existing information but this is not known, it suggests that information is not being communicated effectively to those who need it. Accordingly, the JLA recommends strongly that PSPs keep a record of these 'answerable questions' and deal with them separately from the 'true uncertainties' considered during the research priority setting process.

Uncertainties which are not adequately addressed by previous research will be collated and recorded on a template supplied by the JLA by the appointed information specialist. This will demonstrate the checking undertaken to make sure that the uncertainties have not already been answered. This is the responsibility of the Steering Group, which will need to have agreed personnel and resources to carry this accountability. The data should be submitted to the JLA for publication on its website on completion of the priority setting exercise, taking into account any changes made at the final workshop, in order to ensure that PSP results are publicly available.

Step 5: Prioritisation – interim and final stages

The aim of the final stage of the priority setting process is to prioritise through consensus the identified uncertainties relating to the treatment or management in Heart Surgery. This will be carried out by members of the Steering Group and the wider partnership that represents patients and clinicians.

  • The interim stage, to proceed from a long list of uncertainties to a shorter list to be discussed at the final priority setting workshop (e.g. up to 30), may be carried out over email or online, whereby organisations consult their membership and choose and rank their top 10 most important uncertainties. There are examples of how other PSPs have achieved this at jla.nihr.ac.uk in the Key Documents of the Anaesthesia and Perioperative Care PSP section and the Childhood Disability PSP section.   
  • The final stage, to reach, for example, 10 prioritised uncertainties, is likely to be conducted in a face-to-face meeting, using group discussions and plenary sessions.
  • The methods used for this prioritisation process will be determined by consultation with the partner organisations and with the advice of the JLA Adviser. Methods which have been identified as potentially useful in this process include: adapted Delphi techniques; expert panels or nominal group techniques; consensus development conference; electronic nominal group and online voting; interactive research agenda setting and focus groups. 

The JLA will facilitate this process and ensure transparency, accountability and fairness. Participants will be expected to declare their interests in advance of this meeting. 

Dissemination of findings and research

Findings and research

It is anticipated that the findings of the Heart Surgery Surgery PSP will be reported to funding and research agenda setting organisations such as the NIHR and the major research funding charities. Steering Group members and partners are expected to develop the prioritised uncertainties into research questions, and to work to establish the research needs of those unanswered questions to use when approaching potential funders, or when allocating funding for research themselves, if applicable.


As well as alerting funders, partners and Steering Group members are encouraged to publish the findings of the   Heart Surgery   PSP using both internal and external communication mechanisms. The Steering Group may capture and publicise the results through descriptive reports of the process itself in Plain English. This exercise will be distinct from the production of an academic paper, which the partners are also encouraged to do. However, production of an academic paper should not take precedence over publicising of the final results.

Agreement of the Steering Group

This protocol was agreed by the Steering Group, 26/01/2018.