Determining the Research Priorities of Adults with Fibromyalgia, their Care Providers and Clinicians: A Priority setting Partnership for Fibromyalgia

Protocol

February 24, 2015

Purpose

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

Steering Committee

The Adult Fibromyalgia JLA Steering Committee will be led and managed by the following:

Patient/Caregiver Representatives:

  • Mary Brachaniec, person living with fibromyalgia and chronic pain
  • Lynn Cooper, person living with fibromyalgia and neuropathic pain
  • Trudy Flynn, person living with fibromyalgia whose daughter also lives with fibromyalgia
  • Renée Marleau, person living with fibromyalgia
  • Janice Sumpton, person living with fibromyalgia and neuropathic pain

Clinical Representatives:

  • (Lead) Mary-Ann Fitzcharles, rheumatologist with strong interest in fibromyalgia and pain/chronic pain
  • Ruth Dubin, family physician with a practice focused on chronic pain
  • Hani El-Gabalawy, rheumatologist and Scientific Director of the CIHR Institute of Musculoskeletal Health and Arthritis
  • Kerstin Gerhold, paediatric rheumatologist
  • Winfried Häuser, clinician and pain specialist in Germany who has done meta- analyses of almost all the major treatments for FM
  • Andreas Laupacis, general internist and Canada Research Chair in Health Policy and Citizen Engagement
  • Zachary Walsh, clinical psychologist (behavioural approaches to pain; cannabis)

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

  • The James Lind Alliance (JLA)
    • Katherine Cowan

The Steering Committee includes representation of patient/caregivers and clinicians1. Members of the Steering Committee will agree to the resources, including time and expertise, which they will be able to contribute to each stage of the process. The JLA will advise on this.

Background to the Adult Fibromyalgia PSP

This PSP is a Canadian project overseen by the Institute of Musculoskeletal Health and Arthritis (IMHA) of the Canadian Institutes of Health Research (CIHR), in consultation with 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/caregivers 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.

Aims and Objectives of the Adult Fibromyalgia PSP

Aims and Objectives of the Adult Fibromyalgia PSP

The aim of the Adult Fibromyalgia PSP is to identify the unanswered questions about the management of adult fibromyalgia from patient/caregiver and clinical perspectives and then prioritise those that patients/caregivers and clinicians agree are the most important.

The objectives of the Adult Fibromyalgia PSP are to:

  • engage patients, caregivers, and clinicians in a priority-setting exercise that would identify the scope of uncertainties in the management of adult fibromyalgia;
  • agree by consensus on a prioritised list of those uncertainties, for research;
  • publicise the results of the PSP and process;
  • take the results to research funding bodies to be considered for funding.

Partners

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

  • people who are living with fibromyalgia and chronic pain, and their caregivers;
  • medical doctors, nurses, and allied health professionals with clinical experience of fibromyalgia.

It is important that all organisations which can reach and advocate for these groups should be invited to become involved in the PSP. The Steering Committee 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 Steering Committee 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 Committee 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 upon through consultation among the Steering Committee members, guided by the PSP’s aims and objectives. More details and examples can be found at The James Lind Alliance guide book.

  1. Identification and invitation of potential partners

    Potential partner organisations will be identified through a process of peer knowledge and consultation, through the Steering Committee members’ networks and those of the CIHR Institute of Musculoskeletal Health and Arthritis. Potential partners will be contacted and informed of the establishment and aims of the adult fibromyalgia PSP and invited to canvass their membership to participate in the survey.

    The Steering Committee will draft the invitation and reach agreement as to the best organization to distribute it.

  2. Initial stakeholder meeting / awareness-raising 2

    A preliminary Canadian stakeholder / awareness raising workshop, hosted by the Institute of Musculoskeletal Health and Arthritis (IMHA) in September 2014, discussed an approach to capacity building and research priority setting in the area of chronic pain and fatigue. One outcome of this workshop was an agreement to initiate a James Lind Alliance PSP exercise to identify the top 10 research uncertainties in this area.

    The administrative process for convening the first meeting of the JLA Steering Committee will be managed by institute staff with input from the JLA.

  3. Identifying uncertainties

    Each partner will be asked to help publicise the PSP survey and to solicit from its membership questions and uncertainties of practical clinical importance relating to the management of adult fibromyalgia.

    The methods for reaching potential respondents may be designed according to the nature and membership of each organization, but must be as transparent, inclusive and representative as practicable. As well as disseminating the survey link, methods may include membership meetings, email consultation, internet message boards and focus group work.

    Existing sources of information about management uncertainties for patients/caregivers and clinicians will be searched. These may 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. The Cochrane Library can be accessed through the National Institute for Health and Care Excellence.

  4. Refining questions and uncertainties

    The Steering Committee will make the decision regarding 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 the management and effects of treatments. These raw questions will be assembled and categorised and refined by staff and consulting resources 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 by staff and consulting resources 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 management 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 process3.

    Uncertainties which are not adequately addressed by previous research will be collated and prepared for entry into an adult fibromyalgia section within the UK Database of Uncertainties about the Effects of Treatments (UK DUETs). This will ensure that the uncertainties have been checked to be uncertainties. This is the responsibility of the Steering Committee which will need to have personnel and resources to carry out this accountability. 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.

  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 management of adult fibromyalgia. This will be carried out by members of the Steering Committee and the wider partnership that represents patients and clinicians.

    If initiated, an interim stage to proceed from a long list of uncertainties to a shorter list (e.g. up to 25) may be carried out by the Steering Committee and co-opted individuals with the necessary knowledge and expertise.

    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 the Steering Committee with the advice of the JLA. The top 25-30 uncertainties considered at the final consensus workshop, in addition to the top 10, will be described in the final report.

    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 adult fibromyalgia PSP will be reported to funding and research agenda setting organisations such as the Canadian Institutes of Health Research as well as the major research funding charities. Steering Committee 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 applicable4.

Publicity

As well as alerting funders, partners and Steering Committee members are encouraged to publish the findings of the adult fibromyalgia 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.

Acknowledgement of Consent

This Protocol has been approved by the Adult Fibromyalgia PSP Steering Committee.

Footnotes

Footnote 1

In some cases, it has been suggested that researchers are represented at this level, to advise on the shaping of research questions. However, researchers cannot participate in the prioritisation exercise. This is to ensure that the final prioritised research questions are those agreed by patients, carers and clinicians only, in line with the JLA’s mission.

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Footnote 2

PSPs will need to raise awareness of their proposed activity among their patient and clinician communities, in order to secure support and participation. Depending on budget this may be done by way of a face to face meeting, or there may be other mechanisms by which the process can be launched.

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Footnote 3

Steering Committee members should insert information on how they intend to do this.

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Footnote 4

Add further detail here about how and where the priorities will be developed and researched.

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