Depression PSP protocol

Purpose

The purpose of this protocol is to set out the aims, objectives and commitments of the Depression: Asking the Right Questions (ARQ) partnership and the basic roles and responsibilities of the partners therein.

Steering Group

The Depression: ARQ partnership will be led and managed by the following:

Patient and carer representatives:

• Tania Gergel (Mental Health Research Network external advisory board member and independent service user representative)
• Thomas Kabir (Service Users in Research Coordinator, McPin Foundation
• Judy Lanham (Independent carer representative)
• Paul Lanham (Independent service user representative)
• Megan Rees (Carer and Public Engagement Coordinator, Mental Health Research Network)

Clinical representatives:

• David Kessler (GP, University of Bristol)
• Keith Lloyd (Psychiatrist, University of Swansea)
  Glenys Parry (Clinical psychologist, University of Sheffield)

Primary Funding is provided by MQ, represented by:

• Cynthia Joyce, Chief Executive
• Alison Cranage, Project Manager

Additional funders are represented by:

• The Government of Wales
• TBA
• TBA

Additional support and expertise is provided by:

• Rachel Churchill, Cochrane Depression, Anxiety and Neurosis Group
• Sophie Petit-Zeman, Oxford Biomedical Research Centre

Support and guidance on the James Lind Alliance (JLA) process will be provided by:

• Katherine Cowan, as Chair of the Depression: Asking the Right Questions partnership.

The Steering Group will agree the resources, including time and experience that they will be able to contribute to each stage of the process. The JLA will be able to advice on this.

Background to the Depression: ARQ partnership

The Depression: ARQ project is a natural successor to the Schizophrenia PSP project which reported out in 2011 (See Democratising Clinical Research by Lloyd and White, Nature. 2011 Jun 15;474(7351):277-8. doi: 10.1038/474277a). Since that time, the new charity MQ: Transforming Mental Health was formed to advocate for and support research in the mental health field. MQ agreed to support development of the Depression: ARQ project with a goal to collect a broad and representative sample of responses from UK constituencies and to promote the results of the ARQ process to researchers and research funders. MQ and JLA are logical partners to lead this effort to consult and involve patients, families and carers in the research process.

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 care and treatment questions and/or 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” – or in other words, a question in which it has become clear that further evidence is needed to answer the question with certainty.

Aims and objectives of the Depression: ARQ

The aim of the Depression: ARQ is to identify the unanswered questions about the cause, diagnosis, treatment, care and prevention of any form of depression (NB bipolar disorder is addressed in a different PSP) from patient and clinical perspectives, and then to prioritise those that patients and clinicians agree are the most important.

The objectives of the Depression: ARQ are to:

• work with patients, carers and clinicians to identify uncertainties about the cause, diagnosis, treatment, care and prevention of depression
• to agree by consensus at least one prioritised list of those uncertainties, for research
• to ensure information about outcomes important to patients, families and carers are shared with developers of recommended core outcomes for future research in depression
• to publicise the results of the Depression: ARQ and process
• to take the results to research commissioning bodies to be considered for funding

Participants: Individuals and Partner organisations

Individuals and organisations representing the following groups will be invited to take part in the Depression: ARQ:

• people with a lived experience of depression (at any point in their lifetime)
• carers, families and friends of people who have had depression
• health and social care professionals involved in the treatment and management of depression

All organisations which can reach and advocate for these groups of people should be invited to become involved in the Depression: ARQ. The JLA will take responsibility for ensuring the various stakeholder groups are able to contribute equally to the process.

Partner Organisations wishing to participate in and support the Depression: ARQ will be asked to;

• Disseminate information about the project to their members and affiliates;
• Participate in the recruitment of survey participants.

Organisations that also contribute to the costs of the Depression: ARQ will be recognised as Funding Partners in the project.

Exclusion criteria

A primary concern of the Depression: ARQ project is to give voice to the questions and uncertainties of those most directly affected by research outcomes – patients and their families and carers. To ensure that these voices are heard, organisations will be evaluated by the Steering Committee for any conflicts of interest toward this goal. Input from those organisations with conflict of interest or bias will be excluded from contributing to the project. It is possible, however, that interested parties may participate in a purely observational capacity when the Steering Group considers it may be helpful. Depression: ARQ results will be publicly accessible and made widely available for comment.

The Depression: ARQ will include people aged 16 and over. The survey is not intended for children less than 16 years old.

Methods

This section describes a schedule of proposed stages through which the Depression: ARQ 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 Depression: ARQ aims and objectives.

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 and through the JLA’s existing register of affiliates. Potential partners will be contacted and informed of the establishment and aims of the Depression: ARQ.

Step 2: Launch and awareness raising for the Depression: ARQ

The launch and awareness raising activity will have several key objectives:

• to present the proposed plan for the Depression: ARQ
• to encourage organisations and individuals with an interest in depression to participate in and promote the Depression: ARQ
• to develop a database of those organisations and individuals with which to communicate about the Depression: ARQ throughout the process

This process will be overseen by a project manager within MQ with input from the JLA.

Step 3: Identifying uncertainties and research questions

A survey will be designed to capture questions from people with depression, carers and healthcare professionals relating to the cause, diagnosis, treatment, care and prevention of depression. A period of three to six months will be given to complete this exercise, depending on the number of respondents, the profile of respondents and the range of topics identified before reaching saturation point. The survey will be available in multiple formats to engage as wide a range of respondents as
possible.

Quota sampling will be used to ensure sufficient numbers of respondents are obtained in each of the groups of interest.

Existing sources of information about 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. Other sources will include interview transcripts from the Depression module of Healthtalkonline.

The starting point for identifying sources of uncertainties and research recommendations is NHS Evidence: www.evidence.nhs.uk.

Step 4: Refining questions and uncertainties

The process of managing the data will be undertaken by a team at the University of Swansea, with input from the Cochrane Depression, Anxiety and Neurosis (CCDAN) Group editorial base at the University of Bristol, and overseen by the Steering Group. 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 cause, diagnosis, treatment, care and prevention of depression. These raw questions will be assembled, categorised, and agreed by the teams at the Universities of Swansea and Bristol. They will then be formatted into collated indicative questions which are clear, addressable by research and understandable to all. Where possible, these questions will be presented in PICO format to allow for easy identification of the relevant patient/population, the intervention/exposure, comparison (where appropriate) and important outcomes. The key stakeholder group (patients, family members, carers, clinicians) will also be highlighted. Similar or duplicate questions will be combined where appropriate.

Existing literature will be searched to see to what extent these refined questions have, or have not, been answered by previous research. Where available, systematic reviews of causes, diagnosis, treatment, care and prevention will be targeted and assessed. Where no systematic review is available, primary studies will be identified (including clinical trials, cohort studies and case-control studies as appropriate). Where out-of-date systematic reviews are identified, searches for primary studies will be undertaken to establish the value of an updating exercise. Searches of existing research will focus on sources that are most likely to identify relevant material, including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effectiveness (DARE), the CCDAN trials register, and the Cochrane CENTRAL trials register. Extended searches of key databases (including Medline, EMBASE, and PsycLit) will also be undertaken to identify relevant literature as appropriate. Key national guidelines (including NICE and SIGN) will also be searched for published and unpublished literature and recommendations.

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 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. Steering Group members (including those representing MQ and CCDAN) and other partners will actively disseminate the findings from research evidence that provides answers to these high priority questions.

As part of the project, questions which are about treatment/interventions and are not adequately addressed by previous research will be collated and prepared for entry into the depression section of the UK Database of Uncertainties about the Effects of Treatments (UK DUETs - www.library.nhs.uk/duets). This process ensures transparency about definitive uncertainties taken forward for prioritisation. It also means that all unanswered treatment/intervention questions are published, even if they are not featured in the top 10 priorities. The data will 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 agree how questions which are not eligible for UK DUETs (for example, questions about causes and diagnosis) will be managed and published/taken forward.

We will also ensure that relevant information about outcomes that are important to patients, families or their carers (for example, ability to maintain employment, sleeping at night) are highlighted for future research. Information about key outcomes will also contribute to the development of an agreed set of core outcomes relevant to people with depression to be undertaken in collaboration with the Core Outcome Measures in Effectiveness Trials (COMET) group (www.comet-initiative.org).

Step 5: Prioritisation – interim and final stages

The aim of the interim and final stages of the priority setting process is to prioritise, through consensus, the identified uncertainties relating to the cause, diagnosis, treatment, care and prevention of depression. It is anticipated that there will be more than one prioritisation exercise (interim and final) carried out for the Depression: ARQ partnership reflecting the wide scope and diversity of data. The Steering Group will agree the categories once the data has been finalised. Steering Group members representing relevant constituent groups and the wider Partnership will participate in this process. The methods used for each prioritisation exercise 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 process will be overseen by the Steering Group.

The interim stage, to proceed from a long list of uncertainties to a shorter list (eg up to 30), will be primarily undertaken remotely by email and via web-based tools carried out over email. This is likely involve individuals and organisations choosing and ranking their top 10 most important uncertainties, or direct input from individuals. The Steering Group will agree the method once the survey has been completed and the nature of the data and engagement of the stakeholder groups have been established.

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 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 Depression: ARQ partnership will be reported to funding and research agenda setting organisations such as the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) and the MRC, as well as the major research funding charities including MQ. Steering Group members will work with researchers and funders to develop the prioritised uncertainties into clear research questions. The JLA encourages the Steering Group to keep a record of this activity and of any research activity addressing the priorities.

Publicity

As well as alerting funders, the wider Partnership, interested charities and Steering Group members will publish the findings of the Depression: ARQ partnership 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.

This protocol has been agreed by the Depression: ARQ partnership Steering Group - April 2014