Ear, Nose and Throat PSP Protocol

Purpose of the PSP

The purpose of this protocol is to set out the aims, objectives and commitments of the ENT - aspects of balance Priority Setting Partnership (PSP) and the basic roles and responsibilities of the partners therein.

Steering Group

The PSP will be led and managed by the following:

• The BritishSocietyforAcademicOtolaryngology (part of ENT-UK)
  • Lead: Martin Burton
• Professor Linda Luxon: audiovestibular physician
• Dr Kevin Barraclough – A GP representative
• Andrew Higgins - A patient representative

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

• The James Lind Alliance (JLA)
  • Lead: Lester Firkins

The steering group includes representation of patient groups and clinicians. It has also been agreed that researchers may be represented at this level, to advise on the shaping of research questions, but will not participate in the prioritisation exercise. This will ensure that the final prioritised research questions are those agreed by patients and clinicians only, in line with the JLA’s mission.

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

Background to the PSP

The JLA is a project, which is funded jointly by the National Institute for Health Research and 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.

The BSAO is the research arm of ENT-UK. The constitution of the latter provides that it shall “ ..Assist in the advancement of public education and research in otorhinolaryngology and head and neck surgery”. As a result, the aims of the BSAO include

• The promotion of high-quality research in otorhinolaryngology and head and neck surgery (ORL-HNS) in the UK
• Liaising with local, national and international research bodies and agencies to achieve this aim
• Engaging in activities to help prioritise research topics
• Involving and liaising with patients, health professionals and funders in decisions about research

As a result, members of BSAO met in 2009 to consider prioritisation of ENT research and, with the assistance of the JLA, decided to select a single topic for its first prioritisation venture. Mindful of a wish to involve colleagues in related disciplines – especially audiological ones – it was agreed to focus on balance problems related to ENT.

Aims and objectives of the ENT Aspects of Balance Disorders PSP

The aim of the ENT PSP is to identify the unanswered questions about Aspects of Balance Disorders treatment from patient and clinical perspectives and then prioritise those that patients and clinicians agree are the most important.

The objectives of the ENT PSP are to:

• work with patients and clinicians to identify uncertainties about the effects of balance disorders treatments
• 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:

• patients with disorders affecting their balance.
• medical doctors, nurses and professionals allied to medicine with clinical experience of Aspects of Balance Disorders

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 participate equally to the process.

Exclusion criteria

Organisations which are judged by the JLA or the steering group to have conflicts of interest which may be perceived to adversely and with unacceptable bias affect those organisations’ views and therefore the ultimate findings of the PSP 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 with be agreed through consultation between the partners, guided by the PSP’s aims and objectives.

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 invited to attend and participate in an initial stakeholder meeting.

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

Initial stakeholder meeting

The initial stakeholder meeting will have several key objectives:

• to welcome and introduce potential members of the 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

Following the meeting, organisations which have decided to participate in the PSP will be asked to complete a declaration of interests, including disclosing relationships with the pharmaceutical industry.

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 aspects of balance disorders A period of no longer than to be decided 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, direct mail or email consultation, mail 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.

Suggested first choice existing sources of uncertainties for research recommendations include:

• Cochrane Database of Systematic Reviews
• NHS Evidence – Annual Evidence Updates search
• BMJ Clinical Evidence
• Database of Abstracts of Reviews of Effects
• National Institute for Health Research Health Technology Assessment Programme
• NICE Guidance and the NICE Research Recommendations Database
• Scottish Intercollegiate Guidelines Network
• Relevant Royal Colleges’ guidance

Refining questions and uncertainties

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 into “collated indicative questions” which are clear, addressable by research and understandable to all. Similar or duplicate questions will be combined where appropriate.

The existing literature will be researched to see to what extent these refined questions have, or have not, been answered by previous research (defined as reliable, up to date (less than 3 years) systematic reviews). 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.

It is likely that there will be questions submitted which are not true uncertainties. These may give an indication of areas where existing knowledge or information is not being disseminated effectively Capacity permitting, a record of questions may be maintained by the steering group, and partners can advise their memberships if appropriate.

Uncertainties that are not adequately addressed by previous research will be collated and entered into an appropriate section within the UK Database of Uncertainties about the Effects of Treatments (DUETs). This will ensure that the uncertainties have been actually checked to be uncertainties. This is the responsibility of the steering group, which will need to have agreed personnel and resources to carry this accountability. This is a key component of the JLA process, and the next stage of prioritisation can only proceed upon its completion.

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 ENT aspects of balance. Members of the steering group and the wider partnership that represents patients and clinicians will carry this out.

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 ask for a top 10 - 15 most important uncertainties, ranked or unranked.

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.

Findings and research

It is anticipated that the findings of the PSP will be reported to funding and research agenda setting organisations such as the NIHR 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 PSP, using both internal and external communication mechanisms. The JLA will also capture and publicise the results, through iterative 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.

Agreement of the Steering Group

The following agree to the ENT Priority Setting Protocol:

Martin Burton

Linda Luxon

Dr Kevin Barraclough

Andrew Higgins

Lester Firkins, The James Lind Alliance