Blood Transfusion and Blood Donation PSP Protocol

Contents

The purpose of this protocol is to set out the aims, objectives and commitments of the Blood Transfusion and Blood Donation Priority Setting Partnership (PSP) and the basic roles and responsibilities of the partners therein. This document has been discussed during the inaugural and subsequent meetings of the Blood Transfusion and Blood Donation PSP Steering Group, and updated accordingly.

Steering Group

The Blood Transfusion and Blood Donation PSP will be led and managed by the following:

Patient representatives:

  • Graham Donald
  • Ken Halligan
  • Denis Cave
  • Bridget Le Huray
  • Barry Crossman
  • Heather Saunders 

Clinical representatives: 

  • Mike Murphy (NHS Blood and Transplant, Oxford)
  • Tim Walsh (Intensive Care Medicine, Edinburgh)
  • Toby Richards (Vascular Surgery, University College London)
  • Claire Pulford (Acute Medicine/Trauma Geriatrics, OUH Oxford)
  • Bill Martin (Royal College of Obstetricians and Gynaecologists)
  • Stephen Hibbs (Core Medical Trainee)
  • Susan Brunskill (Senior Information Scientist, NHS Blood and Transplant, Oxford)
  • John Grant-Casey (Audit Manager, NHS Blood and Transplant)

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

The James Lind Alliance (JLA)

  • Leanne Metcalf

Oxford Biomedical Research Centre

  • Sandra Regan

The Steering Group includes representation from patient/carer groups and clinicians. 

The Steering Group has agreed the resources, including time and expertise that they will be able to contribute to each stage of the process (see Terms of Reference).

 

Background to the Blood Transfusion and Blood Donation PSP

The JLA is a project which is overseen by the National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre (NETSCC). Its aim is to provide an infrastructure and process to help patients and clinicians work together to agree which are the most important treatment uncertainties affecting their particular interest, in order to influence the prioritisation of future research in that area. The JLA defines an uncertainty as a “known unknown” – in this case relating to the effects of treatment. Professor Mike Murphy became interested in forming a Priority Setting Partnership to identify important treatment uncertainties in the field of blood transfusion and blood donation. After securing financial support from NHS Blood and Transplant, he approached the JLA, who are providing expertise in PSP methodology. A list of key clinical areas commonly using blood were identified, and a steering group was recruited to ensure wide coverage of these fields.

Aims and objectives of the PSP

The aim of the Blood Transfusion and Blood Donation PSP is to identify the unanswered questions about blood transfusion and blood donation from patient and clinical perspectives and then prioritise those that patients and clinicians agree are the most important. The objectives of the Blood Transfusion and Blood Donation PSP are to:

  • work with patients, blood donors and clinicians to identify uncertainties about blood donation and the use of blood transfusion
  • agree by consensus a prioritised list of those uncertainties, for research
  • publicise the results of the PSP and process
  • take the results to research commissioning bodies to be considered for funding

The scope of the Blood Transfusion and Blood Donation PSP is to identify key uncertainties in blood transfusion and blood donation. By blood transfusion, we mean the therapeutic use of red blood cells, platelets and plasma in patients of any age and in any hospital department. We are considering uncertainties across the whole clinical pathway from blood donation through to recovery from transfusion, as well as treatment strategies that provide alternatives to using blood.

The scope does not include laboratory aspects of the transfusion process – (e.g. processing and screening blood, blood grouping or cross-matching). Neither does it include the use of more specialist blood products such as cryoprecipitate or individual clotting factors.

Partners

Organisations and individuals will be invited to take part in the PSP, which represent the following groups:

  • People who have experienced blood transfusion or those that might need one, and their carers or guardians
  • People who donate blood
  • Medical doctors, nurses and professionals allied to medicine with clinical experience of using blood transfusions
  • Those with an interest in strategies that lead to the avoidance of transfusions including those from the Jehovah's Witness community
  • Those involved in the management of hospitals and blood transfusion laboratories

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 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 partners, guided by the PSP’s aims and objectives. More details and examples can be found at http://www.jla.nihr.ac.uk/jla-guidebook/.

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. The Steering Group will adapt a standard invitation, and an agreement should be reached as to the best organisation to distribute it.

An initial list of possible partners is below: 

  • National Blood Transfusion Committee (NBTC) – has links to all medical colleges and professional organisations involved in transfusion including the Royal Colleges of Physicians, Pathologists, Surgeons, Anaesthetists, Paediatrics, Obstetricians and Gynaecologists, Nursing, Midwives, Emergency Medicine, and the Intensive Care Society, Serious Hazards of Transfusion, British Blood Transfusion Society, British Society for Haematology, NHS Blood & Transplant, and the equivalent national transfusion committees in Wales and Scotland. 
  • NBTC Patient Blood Management Working Group
  • NHS Blood and Transplant (NHSBT) – which has a monthly mailing to all hospital transfusion laboratories and transfusion nurses.
  • Doctors.net
  • Blood donor group 
  • PREVENTT members
  • Norfolk Zipper Club 
  • Mumsnet 
  • National Childbirth Trust
  • Age UK
  • Interval study participants
  • Alcoholics Anonymous (rationale: high incidence of chronic liver disease and therefore increased risk of variceal bleeding requiring transfusion)
  • Jehovah’s Witnesses
  • Association of Anaesthetists
  • Association for Perioperative Practice
  • Independent Cancer Patient Voices
  • Patient Liaison Groups of the Royal Colleges of Physicians and Surgeons
  • Patients Association
  • UK Thalassaemia Society Sickle Cell Society
  • Royal College of General Practitioners 
  • Crohns and Colitis UK
  • British Maternal and Fetal Medicine Society
  • British Association of Perinatal Medicine
  • Obstetric Anaesthetists Association
  • Aplastic Anaemia Trust 
  • MPD (Myeloproliferative Disorders) Support
  • Myeloma UK
  • Lymphoma Association
  • Bloodwise 
  • Anaemia Nurse Specialist Association (ANSA)

Step 2: Raising Awareness: website and social media

We will not hold an initial face-to-face meeting with partners but will embark upon an awareness raising campaign about the aims of the PSP. A website for this purpose (with a simple URL like www.transfusionquestions.com ) will be drafted by the patient members of the steering group and hosted by OUH. We recognize the power of social media, and Mr Toby Richards has agreed to oversee the setup of a Twitter page for the PSP.

Step 3: Identifying treatment uncertainties

Each partner will identify a method for soliciting from its members questions and uncertainties of practical clinical importance relating to blood transfusion. A period of eight weeks 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. We will primarily use a web-based questionnaire but as a backup paper copies of the questionnaire can be made available by Sandra.

Existing sources of information about treatment uncertainties for patients and clinicians will be searched – this part of the process will be led by Susan. 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 . Other reference sources are www.blood.co.uk ; www.transfusionguidelines.org.uk ; NICE Guidelines: www.nice.org.uk/guidance ; the Transfusion Evidence Library: www.transfusionevidencelibrary.com ; and websites containing details of ongoing trials, for example www.clinicaltrials.gov  and the World Health Organisation Trial Repository: http://www.who.int/ictrp/en

Step 4: Refining questions and uncertainties

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 into “collated indicative questions” which are clear, addressable by research and understandable to all. Similar or duplicate questions will be combined where appropriate. John will lead on this part of the process. The JLA will participate in this process as an observer, to ensure accountability and transparency.

The existing literature will be researched to see to what extent these refined questions have, or have not, been answered by previous research (again, led by Susan).

Sometimes, uncertainties are expressed that can in fact be resolved with reference to existing research evidence – ie 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.

Susan will collate and record uncertainties which are not adequately addressed by previous research on a template supplied by the JLA. 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 do this. 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 blood transfusion. 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 (preferably under 50) to a shorter list (e.g. 20-30), may be carried out over email, whereby organisations consult their membership and choose and rank their top 10 most important uncertainties.

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. 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.

 

Findings and research

It is anticipated that the findings of the Blood Transfusion and Blood Donation PSP will be reported to funding and research agenda setting organisations such as the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), which includes the Health Technology Assessment Programme, and the MRC, as well as the major research funding charities. Steering Group members and partners are encouraged 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.

Publicity

As well as alerting funders, partners and Steering Group members are encouraged to publish the findings of the Blood Transfusion and Blood Donation PSP using both internal and external communication mechanisms. The JLA may also capture and publicise the results, through descriptive reports of the process itself. 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 the final results.

Signed by the Steering Group

This protocol was agreed by the Steering Group.