Purpose
The purpose of this protocol is to set out the aims, objectives and commitments of the Tinnitus Priority Setting Partnership (PSP) and the basic roles and responsibilities of the partners therein.
Steering Group
The Tinnitus PSP will be led and managed by the following:
Patient representative/s:
- Emma Harrison
- Philip Nash
- Organisation: British Tinnitus Association
- Chief Executive: Mr David Stockdale
Clinical representative/s:
- Mr Don McFerran, Consultant Ear Nose and Throat Surgeon
- Organisation: Royal College of GPs
- Representative to be confirmed
- Organisation: British Society of Audiology
- Chair of Adult Rehab Special Interest Group: Mr Tim Husband
Research representative:
- Organisation: NIHR National Biomedical Research Unit in Hearing
- Scientific Director : Prof Deborah Hall
The Partnership and the priority setting process will be supported and guided by:
- The James Lind Alliance (JLA)
- Lester Firkins
The Steering Group includes representation from patients 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 be able to advise on this.
Background to the Tinnitus PSP
The JLA is a project which is hosted by the National Institute for Health and Care Research (NIHR). 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 Tinnitus PSP has been convened to allow patients and clinicians to have an input in research priorities and uncertainties in the treatment of tinnitus. Several founders have established the Tinnitus PSP to help raise awareness of the need for tinnitus research, and to ensure patients and clinicians lead the identification and prioritisation of these. The initial founders are:
- British Tinnitus Association
- Judi Meadows Memorial Fund
- NIHR National Biomedical Research Unit in Hearing
Aims and objectives of the Tinnitus PSP
The aim of the Tinnitus PSP is to identify the unanswered questions about Tinnitus treatment from patient and clinical perspectives and then prioritise those that patients and clinicians agree are the most important.
The objectives of the Tinnitus PSP are to:
- work with patients and clinicians to identify uncertainties about the effects of treatments for tinnitus
- to agree by consensus a prioritised list of those uncertainties, for research
- to publicise the results of the PSP and process
- to make the results to research available to 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 or have had tinnitus
- family and friends of people who have or have had tinnitus
- medical doctors, nurses and professionals allied to medicine with clinical experience of tinnitus
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 advising how the various stakeholder groups are able to participate equally in the process.
Organisations wishing to participate in the PSP will be required to affiliate to the JLA 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 (e.g. pharmaceutical companies) may be judged by the Steering Group to have conflicts of interest. These may be perceived to adversely affect those organisations’ views, causing unacceptable bias. As this is might be perceived to bias the ultimate findings of the PSP, those organisations will not be invited to participate in the prioritising process. However, 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.
Identification and invitation of potential partners
Potential partner organisations and individuals 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 Tinnitus PSP and invited to attend and participate in an initial awareness meeting. Invitation to the initial awareness meeting will be as broad as possible.
Initial awareness meeting
The initial awareness meeting will have several key objectives:
- to welcome and introduce potential members of the Tinnitus 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 meeting will be chaired by the JLA, with the administrative process of convening it managed by the Steering Group in collaboration with the JLA.
Following the meeting, partner organisations and individuals who have decided to participate in the PSP will be asked to complete a declaration of interests, including disclosing relationships with potential sources of bias.
Identifying treatment uncertainties
Each partner will identify a method for soliciting from its members uncertainties of practical clinical importance relating to the treatment and management of tinnitus. A period of two 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 JLA will participate in this process as an observer, simply to ensure accountability and transparency.
The British Tinnitus Association will collate the survey responses producing a list of “raw” unanswered questions about diagnosis and the effects of treatments. These raw questions will be categorised and refined by NIHR National Biomedical Research Unit in Hearing into “collated indicative questions” which are clear, addressable by research and understandable to all. Similar or duplicate questions will be combined where appropriate. This will be overseen and approved by nominated members of the Steering Group, to include patient and clinician representation.
The existing sources of information will be evaluated to determine 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 - 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. A list of “unrecognised knowns,” will be presented to the Steering Group and PSP Partners. These will then be used by Partners to disseminate information on “unrecognised knowns,” to inform those unaware of the evidence as part of an ongoing education/awareness programme.
Uncertainties which are not adequately addressed by previous research will be collated and entered into a tinnitus section within the UK Database of Uncertainties about the Effects of Treatments (UK 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. (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 tinnitus.
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 them to consider the long list, then rank their top most important uncertainties. If the refined list is deemed too long, and therefore unmanageable, the Steering Group will need to agree a fair and transparent method for reducing it. The JLA can advise on this process.
The final stage, to prioritise the short listed uncertainties and agree a top 10, is will be conducted in a face-to-face meeting, using group discussions and plenary sessions. Voting will take place, and will be confined to patients and clinicians. Equal weighting will be given to both groups.
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. The Steering Group will need to agree available resources and support for convening a face to face meeting.
Findings and research
It is anticipated that the findings of the Tinnitus 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 for 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 Tinnitus PSP using both internal and external communication mechanisms, including raising awareness of the results among the public and scientific audiences. 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. The Partnership is asked to keep the JLA informed of activity undertaken to publicise the results of the priority setting exercise.
Signed by the Steering Group
The PSP agree to follow the Tinnitus Priority Setting Protocol.