Spinal Cord Injury PSP Protocol

Purpose

The purpose of this protocol is to set out the aims, objectives and commitments of the Spinal Cord Injury Priority Setting Partnership (SCI PSP) and the basic roles and responsibilities of the partners therein.

Steering Group

The SCI PSP will be led and managed by the following:

Patient & carer representative/s:

• Spinal Injuries Association (SIA)
  
  • Mr Dave Bracher, Vice-Chair of the Trustees
    Ms Christa Dyson, Trustee
• Cauda Equina Syndrome UK Charity (CES UK)
  • Mrs Ann Glover, Chair of Trustees
• Transverse Myelitis Society (TMS)
  
  • Mr Lew Gray, Secretary
• Carer representative (Independent, no organisation representative)
  • Mrs Val Javens

Clinical representative/s:

• British Association of Spine Surgeons (BASS); &
• Society of British Neurological Surgeons (SBNS)
  
  • Mr Sashin Ahuja, Orthopaedic surgeon, Research Officer BASS
• UK Spine Societies Board (UKSBB)
  
  • Prof Jeremy Fairbank, Orthopaedic surgeon, Chair
• Multidisciplinary Association of Spinal Cord Injury Professionals (MASCIP)
  
  • Dr Angela Gall, Consultant Rehabilitation Medicine, Past Chair
• British Association of Spinal Cord Injury Specialists (BASCIS)
  
  • Prof Wagih El Masri, spinal injury rehabilitation specialist, Emeritus Chair

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

• The James Lind Alliance (JLA)
  
  • Ms Katherine Cowan, Consultant
• Stoke Mandeville Spinal Foundation (SMSF)
  
  • Dr Joost van Middendorp, Research Director

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

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.

Background to the SCI PSP

The JLA is a project which is funded by the National Institute for Health Research with support from the Medical Research Council. 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.

Although many small-scale research priority exercises have been conducted in different institutions and associations in the past, no British research agenda for spinal cord injury (SCI) has been introduced and endorsed to date. Most of the previous priority exercises have been initiated and conducted by researchers themselves. As the JLA has a clear focus, patients and clinicians, SCI research networks or associations are not considered eligible for participating in the priority setting consensus process. However, the outcomes of this SCI PSP may be of particular importance for SCI research organisations as it will guide them in scoping and deciding on future research topics. Moreover, knowledge of the research needs identified through this SCI PSP will enable funding and research agenda setting organisations to wisely allocate funding for future research initiatives.

The SCI PSP Steering Group is grateful for the generous financial support from the Oxford Biomedical Research Centre.

Aims, scope and objectives of the SCI PSP

The aim of the SCI PSP is to identify the unanswered questions about SCI treatment from people with SCI, carers and health care professionals and then prioritise those that involved parties agree are the most important. The steering group decided to include the following related medical conditions in this partnership: Cauda Equina Syndrome (CES) and Transverse Myelitis (TM). In this document these two medical conditions are also covered under the acronym ‘SCI’, unless stated otherwise. The SCI PSP will not cover research questions paediatric SCI, as this is a highly specialised area deserving specific attention.

The objectives of the SCI PSP are to:

• work with patients, carers and clinicians to identify treatment uncertainties for SCI
• 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

Partners

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

• people who have (had) SCI
• carers and relatives of people who have (had) SCI
• healthcare professionals dealing with SCI

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.

Organisations wishing to participate in the PSP have been asked to affiliate to theJLA in order to demonstrate their commitment to the aims and values of the JLA. Please note the affiliation procedure formerly available on the JLA website was discontinued in 2015.

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.

Methods

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 in the JLA Guidebook.

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 and through the JLA’s existing register of affiliates. Potential partners will be contacted and informed of the establishment and aims of the SCI PSP and invited to attend and participate in an initial stakeholder meeting.

The Steering Group should draft the invitation, and an agreement should be reached as to the best organisation to distribute it.

Initial stakeholder meeting / awareness raising

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

• to welcome and introduce core members of the SCI 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

The administrative process for convening this meeting will be managed by the Steering Group with input from the JLA.

Identifying treatment uncertainties

Each partner will identify a method for soliciting from its members questions and uncertainties of practical clinical importance relating to the treatment and management of SCI. The survey will be designed by Christa Dyson and Dr Joost van Middendorp and will be a piloted in a small sample to evaluate whether the answers comply with the scope of the SCI PSP. When successful, the survey will be distributed among the memberships of involved organisations. A period of approximately 3 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.

Refining questions and uncertainties

The Steering Group nominated Dr Harriet Allison as the ‘SCI PSP Information Manager’. The JLA will advise and estimated/the amount of time likely to be required for the execution of this phase. The JLA will participate in this process as an observer, to ensure accountability and transparency.

The consultation process (eg. first survey) will produce “raw” unanswered questions about the effects of management strategies for SCI. 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.

Next, the existing literature will be researched to see to what extent these refined questions have, or have not, been answered by previous research. Dr Joost van Middendorp will take the lead and Dr Harriet Allison will assist in this process.

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. The identified "unrecognised knowns" will be documented and interested partners will be briefed about this.

Uncertainties which are not adequately addressed by previous research will be collated and prepared for entry into a SCI section within the UK Database of Uncertainties about the Effects of Treatments (UK DUETs). This process will ensure that the uncertainties have been actually checked to be uncertainties. It is the responsibility of the Steering Group, which will need to have agreed personnel and resources to carry this accountability. Dr Joost van Middendorp is the designated Steering Group representative responsible for successful database entries. The data should be entered into UK DUETs on completion of the priority setting exercise, in order to ensure any updates or changes to the data have been incorporated beforehand. The Steering Group will monitor and verify the progress made throughout the two described stages. 

(Please note the UK DUETs database was discontinued in 2015. All PSP uncertainties now appear on the JLA website).

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 of SCI. This will be carried out by members of the Steering Group and the wider partnership (eg. survey 2) that represents patients and clinicians.

The interim stage, to proceed from a long list of uncertainties to a shorter list (e.g. up to 20), 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 SCI PSP will be reported to funding and research agenda setting organisations such as the NIHR Evaluation, Trials and Studies Coordinating Centre (which includes the HTA 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 SCI 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 of the final results. Depending on the interest from partners, the Steering Group may be involved in publicising the "unrecognised knowns" identified in this PSP.

Signed by the Steering Group

The undersigned agree to follow the SCI Priority Setting Protocol.

• Mr Dave Bracher & Ms Christa Dyson representing the Spinal Injuries Association
• Mrs Ann Glover representing the Cauda Equina Syndrome UK Charity
• Mr Lew Gray representing the Transverse Myelitis Society (TMS)
• Mrs Val Javens, independent representative of SCI carers
• Mr Sashin Ahuja, representing both the British Association of Spine Surgeons & the Society of British Neurological Surgeons
• Prof Jeremy Fairbank, representing the UK Spine Societies Board
• Dr Angela Gall, representing the Multidisciplinary Association of Spinal Cord Injury Professionals
• Prof Wagih El Masri, representing the British Association of Spinal Cord Injury Specialists
• Ms Katherine Cowan, representing the James Lind Alliance
• Dr Joost van Middendorp, representing the Stoke Mandeville Spinal Foundation