This is a protocol which sets out the aims, objectives and commitments of the second phase of the James Lind Alliance Priority Setting Partnership in Cystic Fibrosis  and the basic roles and responsibilities of the partners therein.  

The James Lind Alliance Priority Setting Partnership in cystic fibrosis was carried out in 2016 using a robust and widely accepted methodology to develop the top 10 questions for clinical research in CF, through discussions with both the clinical and patient community.

We now aim to explore four of the top ten questions from this process and develop them into a series of testable hypotheses for clinical research. Where the hypothesis will be tested in a clinical trial, we will develop a PICO question for each hypothesis (Population, Intervention, Comparator & Outcome). 

We will use online surveys and focus groups to achieve our aim

Rowbotham, Nicola J.

Smith, S.J.

Smyth, Alan R.

Nottingham ePrints

Working With The Patient And Clinical Community To Deliver ClinicalResearch In Cystic FibrosisJames Lind CF Phase II@question CFPROTOCOL [updated 8th February 2018]AUTHORS: S Smith*, NJ Rowbotham, AR Smyth*Corresponding authorADDRESS: Evidence Based Child Health Group, Division of Child Health, Obstetrics &Gynaecology, E Floor East Block, Queens Medical Centre, Nottingham NG7 2UH.Email: sherie.smith@nottingham.ac.ukAFFILIATION: Evidence Based Child Health Group, University of Nottingham, UKAbbreviations:JLA: James Lind AlliancePSP: Priority Setting PartnershipMDT: Multi-disciplinary TeamPwCF: person with CF1. Purpose of the advisory panel and backgroundThe purpose of this protocol is to set out the aims, objectives and commitments of the secondphase of the James Lind Alliance (JLA) Priority Setting Partnership (PSP).in Cystic Fibrosis (CF)and the basic roles and responsibilities of the partners therein.The James Lind Alliance Priority Setting Partnership PSP (JLA PSP) in cystic fibrosis (CF) has useda robust and widely accepted methodology to develop the top 10 questions for clinical research inCF, through discussions with both the clinical and patient community1. The top ten priorities areavailable on the James Lind Alliance website2.We believe that this represents an important step towards “co-production” of clinical research, sothat the conception, delivery and dissemination of research are each conducted in partnership withthe patient community3. However, a number of the questions in the JLA PSP top 10 are very broadand do not lend themselves to being transformed into a testable hypothesis for a clinical trial orother clinical research study. Indeed, some of the top 10 questions may give rise to several clinicalstudies. We believe there is a need to have an ongoing conversation with the CF community (bothlay and professional) in order to gain a deeper understanding of what JLA PSP participantsunderstand by the top 10 research questions and to design the research studies which meet theirneeds. Four of the top 10 questions stand out as requiring further discussion.What are the effective ways of simplifying the treatment burden of people with CysticFibrosis? (Q1)How can we relieve gastro-intestinal (GI) symptoms, such as stomach pain, bloating andnausea in people with Cystic Fibrosis? (Q2)What effective ways of motivation, support and technologies help people with CysticFibrosis improve and sustain adherence to treatment? (Q6)Can exercise replace chest physiotherapy for people with Cystic Fibrosis? (Q7)Other questions in the top 10 could be formulated into testable hypotheses more readily and aspecific study design then explored with the patient community.2. Aims and objectivesWe aim to set up an advisory panel representative of the whole CF community (lay andprofessional) to allow us to explore the four questions above and develop them into a series oftestable hypotheses for clinical research. Where the hypothesis will be tested in a clinical trial, wewill develop a PICO question for each hypothesis (Population, Intervention, Comparator &Outcome).The objectives of the @questionCF advisory panel are to: work with people with CF, their family and friends, and clinicians to gain a deeperunderstanding of what JLA PSP participants understand by four of the top 10 researchquestions produce testable hypotheses for research studies which meet the needs of the CFcommunity.3. The Steering GroupThe @questionCF advisory panel will be led and managed by the following:Patient representative/s: Zoe Elliott (Parent of children with CF) Oli Rayner (pwCF) Katie Gathercole (pwCF)Clinical representative/s: Alan Smyth (Respiratory Paediatrician) Tracey Daniels (CF Physiotherapist) Ed Nash (adult respiratory physician) Alistair Duff (psychologist) Sarah Collins (dietician) Suja Chandran (social worker) Patrick Wilson (pharmacist) Matt Hurley (consultant respiratory paediatrician) Michelle Tabberner (CF Nurse)The project will be supported and guided by: University of Nottinghamo Sherie Smith (Project coordinator)o Nicola Rowbotham (Academic Clinical Fellow)o Paul Leighton (Qualitative Researcher) Sophie Herbert (F1 junior doctor with interest in research) CF Trusto Keith Brownlee (Director of Impact)o Lorna Allen (Patient and Public Involvement Co-ordinator)The Steering Group includes representation from lay and professional groups. The Steering Groupwill agree the resources, including time and expertise that they will be able to contribute to eachstage of the process.4. The wider ContributorsOrganisations and individuals will be invited to be involved with this phase of the project ascontributors. Contributors are groups or individuals who agree to take part in the online surveys andwho will then be invited to participate more fully by joining our advisory panel as members. Advisorypanel members will be involved in the design of and participation in the focus groups for moredetailed analysis of the priorities. Contributors represent the following groups: people who have CF family and friends of people who have CF medical doctors, nurses and professionals allied to medicine with clinical experience of treatingCF.We will work with others who are undertaking activity in this field – both identifying researchpriorities, with the patient community and disseminating research findings to the community. The UK Cystic Fibrosis Trust – the “Insight” survey, distributed by the CF Trust, asked aboutall aspects of living with CF and received over 1000 responses in the last year. The US CF Foundation, whose similarly named “Insight” programme seeks to identifyresearch questions which can be answered through the US CF Registry.https://www.cff.org/Get-Involved/Community/Contribute-to-Our-Research/ The Journal of Cystic Fibrosis, who produce “CF Research News” – lay summaries ofresearch papers.5. The methods we will useThe majority of the project will be carried out using online methods to avoid the risk of cross-infection from face to face work and to maximise the reach of the surveys. We will work through thefollowing steps.Step 1: Identification and invitation of potential partnersPotential partner organisations will be identified through a process of peer knowledge andconsultation, through the Steering Group members’ networks. Potential partners will be contactedand informed of the establishment and aims of the @questionCF.Step 2: Initial steering group meeting / awareness raisingThe initial steering group meeting / awareness raising will have several key objectives: to welcome and introduce potential members of the @questionCF2 steering group & advisorypanel to present the proposed plan for the @questionCF2 project to initiate discussion, answer questions and address concerns to identify those potential partner organisations which will commit to the @questionCF advisorypanel and identify individuals who will be those organisations’ representatives and the@questionCF advisory panel’s principal contacts to establish principles upon which an open, inclusive and transparent mechanism can be basedfor contributing to, reporting and recording the work and progress of the @questionCF advisorypanel. We will hold three further steering group meetings over the course of the project to guide theprocess.Step 3: Launching the project and dissemination of surveysWe will approach participants who gave us their contact details as part of the JLA PSP in CF andwe will invite them to join the @question CF advisory panel. We will also publicise this engagementwork via Twitter, other social media and via our website in order to open up participation to thewhole CF community. Participants will be asked to complete an intial online survey (priority one) andasked if they would like to continue supporting our research by joining our advisory panel..Step 4: Exploring and clarifying the research questionTwo initial questionnaires, for each of the four priorities, will be launched sequentially over a periodof twelve months in total – one targeted at people with CF and parents of people with CF and theother at CF health care professionals, to explore thoughts, wants and needs around each of the fourresearch priorities mentioned above. The survey content will be guided by the original questions submitted during the PSP thatfed into the final priorities. We will use the online survey tool SurveyMonkey® to distribute the questionnaires andresponses will be anonymous. We will analyse the data from the surveys in MS Excel to look for themes emerging whichcan be taken forward into focus groups for more detailed discussion. The process ofdeciding what to take forward will be agreed by the steering group. At this stage participants will be invited to express their interest in taking part in a focusgroup to further refine the questions after the surveys close. Surveys will be designed and managed by Nicola Rowbotham and Sherie Smith with inputfrom the Steering group.Step 5: Refining priorities into ‘PICO’ research questionsStep 4 will produce clinical trial ideas. These raw ideas will be assembled, categorised and refinedby Sherie Smith and Nicola Rowbotham and taken to the advisory panel. Together, the researchteam and the advisory panel will generate a focus group agenda from the themes that emerge.A focus group for each of the four priorities will be attended by both lay and professional members ofthe CF community to discuss the ideas generated in greater depth. Where the hypothesis could betested in a clinical trial, we will develop a PICO for each hypothesis (Population, Intervention,Comparator & Outcome).Focus groups We will aim to recruit eight to ten members of the advisory panel to participate in a given focusgroup We will run one focus group for each of the research priorities we are investigating (n = 5) We will ensure that the group is representative of lay and professional members The discussion guide will be generated from the results of the surveys. At least one of the research team will facilitate the focus groups which will be run using onlinemeeting software (BlueJeans®). The discussion will be recorded via the online meeting software.Step 6: Finalisation of PICO questions by @questionCF advisory panelThe aim of the final stage is to prioritise through consensus the identified PICO questions relating tothe CF research priority. This will be occur through a final online prioritisation survey open to allmembers of the @questionCF advisory panel. A modified dephi process will be used, utilising Likertscales to enable participants to rank the trial questions in order of priority.6. Dissemination of findings and researchFindings and researchIt is anticipated that the findings of the @questionCF advisory panel will be reported to funding andresearch agenda setting organisations such as the NIHR and the major research funding charities.Steering Group members and partners are expected to develop the findings into clinical researchplans to use when approaching potential funders, or when allocating funding for researchthemselves, if applicable.PublicityAs well as alerting funders, partners and Steering Group members are encouraged to publish thefindings of the @questionCF advisory panel using both internal and external communicationmechanisms. The findings will be written up in at least one journal paper (potential publishersincluding Thorax and Journal of Cystic Fibrosis). We will also present findings at the European andNorth American Cystic Fibrosis conferences. As with all our work we will keep the CF Communityinformed of our findings through online lay accessible infographics, blogs and vlogs (video media).References1. Rowbotham NJ, Smith S, Leighton PA, et al. The top 10 research priorities in cystic fibrosis developed by apartnership between people with CF and healthcare providers. Thorax 2017 4th August 2017; e-pubahead of print.2. James Lind Alliance. Cystic Fibrosis Top Ten Research Priorities 2017 [Available from:http://www.jla.nihr.ac.uk/priority-setting-partnerships/cystic-fibrosis/top-10-priorities.htm.3. Rowbotham NJ, Smyth AR. The patient voice in research - Supporting actor or starring role? J Cyst Fibros2017;16(3):313-14.

Working with the patient and clinical community to deliver clinical research in cystic fibrosis. James Lind CF Phase II

http://eprints.nottingham.ac.uk/55412/1/James%20Lind%20CF2%20Protocol_140218.pdf

Working with the patient and clinical community to deliver clinical research in cystic fibrosis. James Lind CF Phase II

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