- Figure 1
Summary of patient involvement in the EMBARC project.
- Figure 2
A group of bronchiectasis patients address the EMBARC annual meeting.
- Figure 3
Marta Almagro opens the first World Bronchiectasis Conference.
- Table 1
Recommendations for clinicians, written by both physicians and patients, to ensure appropriate patient engagement
Barriers Recommendations Representativeness (i.e. are patients involved in the project representative of the overall patient population?) Involve more than one patient in any project. This has multiple benefits, including increasing the representativeness, but also allowing for peer support and ensuring there is representation if patients become unwell and are unable to attend meetings or participate in activities. If patients are attending as representatives of a large patient group or organisation, ensure that discussions or outcomes are also shared with the wider group so that a larger body of patients has the opportunity to contribute.Ensure patient representatives understand that they are representing other patients and not just giving their personal story.Incorporate broader patient data into data collection, e.g. by performing a literature review for patient perspective articles or performing a patient survey with a sufficient sample size to be considered representative of wider patient opinion. Patient representatives can advise on the most relevant patient-centred search terms of literature reviews and ELF can also provide advice on this. Language Currently, there is a requirement for participating patients to speak English. This can result in a UK/Ireland bias and so it is important to try to achieve representation of other European countries. Where activities can be multilingual (such as patient surveys), these methods should be used. ELF provides support for multilingual focus groups and surveys. Patient travel and reimbursement Face-to-face meetings are the most effective way to engage patients. The cost of this is the requirement for patients to travel to meetings, which is expensive and time consuming. It is essential that the project funds patient travel adequately and in an appropriate way and timeline. Where travel is prevented through ill health or other issues, teleconference facilities should be offered to avoid excluding patients’ valuable contributions.The INVOLVE guidelines (www.invo.org.uk) from the National Institute for Health Research (UK) suggest that, wherever possible, patients involved in research projects should receive payment or a fee for participation. However, they note that consideration should be given to whether payments may affect state benefits. Lack of scientific knowledge or background Patients cannot be expected to be experts in clinical trial design, observational research or guideline methodology. In the ideal scenario, patients would be trained with the knowledge that they require, through schemes such as the European Patient Ambassador Programme (EPAP; www.epaponline.org). If it is not feasible for patients to have such training, we recommend:1)Project chairs meet with patients prior to meetings so that patients can have an explanation of the context of the expected discussion;2)Use of natural breaks in discussion to explain to patients in lay terms what is being discussed and ask patients specific questions where their input is needed;3)Debriefing with patients after meetings to ensure they have understood the discussions.For rare diseases, including rare pulmonary diseases, EURORDIS (Rare Diseases Europe) provides training to empower patient representatives to participate in clinical research and other clinical projects. Perception of “tokenism” Set specific objectives for patient involvement in projects and communicate these to all stakeholders. The professional participants in a task force or research project should understand what the role of patients in the project is, and patients should understand exactly what is expected of them.Involve patients as equals. We have had a very positive experience of including patients as full equal members of a guideline task force. Patients isolated or ignored in meetings There is a responsibility on the chairs of meetings to prompt participants to involve the patient representatives, and to prompt patients to provide input where appropriate. Patient participation can be facilitated by making clear the role of patients to both the patients and physicians at the start of the project.Smaller group work, such as subcommittees or working groups, can make it easier for patients to participate as groups are smaller, but there is similarly a responsibility on subgroup participants to ensure patients are involved. Patients lacking confidence to get involved Welcome and introduce patients at the start of every meeting. Encourage all task force or study team members to introduce themselves; even if all of the professionals are well known to each other, they are not well known to the patients. Chairs should give an introduction explaining the role of the patients and encouraging task force or study members to involve the patients.It is particularly helpful for patients to meet with the chairs or ELF representatives prior to meetings (and particularly the first meeting) so that they know what to expect and get to know some other people in the meeting prior to joining larger group meetings.Research or guideline meetings often also involve social events and it is appropriate to involve patients in social events so that they can get to know panel members in a more relaxed setting and are not excluded. Conflicts of interest and confidentiality Just like physicians, patients may have conflicts of interest that are relevant to their participation in task forces and research projects.Project chairs should give consideration to how they will manage patients’ conflicts of interest. This may include financial conflicts of interest (patients with business interests related to the healthcare field or having relationships with pharmaceutical companies) or non-financial conflicts of interest. The most frequent non-financial conflict of interest is that the patient may be a patient under the care of a member of the task force. This is not necessarily a problem, but consideration should be given to whether patients may feel coerced to participate, and whether they may feel able to give their honest opinion, which may be at odds with the opinion of their physician.Patient confidentiality should be maintained at all times. Patients may choose to share information about their medical background, but their physician should not disclose information to the panel or panel members without patient consent. Lack of awareness of governance and regulatory aspects around patient involvement Clinicians may be concerned about involving patients in research in the belief that all work with patients requires ethical or other governance approvals. Note that ethical approval is not required to involve members of the public in designing or conducting research studies, participating as a member of an advisory group or helping to develop study materials or questionnaires. Identifying suitable patients Consider the knowledge and experiences you need to inform the project. Try to create a “job description” or specification of the kind of patient you wish to involve.Involve patient organisations wherever possible as they provide peer support, training and, in some cases, resources to aid patients. Involving patient organisations also generally means the representatives can be the collective voice of a group rather than simply representing themselves.Consider the commitment required by patients. It is important to remember that patients have jobs, lives and commitments of their own and may not be able to attend all meetings or respond to short deadlines. Give information about the time commitment and project duration up front to let patients make an informed decision about whether to participate. - Table 2
EMBARC patients’ key recommendations for patient involvement in research
Do Don’t Involvement Involve patients at an early stage
Involve patient organisations and more than one patient
Ensure patients are able to really influence the work
Ask patient opinions once decisions are already made
Assume that individual patients are representative of a wider patient population
Exclude patients from key meetings/decisions
Preparation and training Make sure patients know what is expected from them
Be clear about time commitment required and project duration
Provide formal training if needed
Consider in advance what to do if patients become ill
Discuss with patients beforehand if the project is likely to touch on sensitive or potentially upsetting issues such as mortality rates, serious complications or the effectiveness/ineffectiveness of treatments
Give patients insufficient notice of meetings or deadlines for feedback
Expect patients to have any special knowledge or skills; training should be provided if these are required
Allow the day of the meeting to be the first occasion the chairs meet or speak with the patients
Discuss patients’ confidential medical information either pre-meeting or during meetings
Meetings Consider meeting venues that are accessible to patients
Organise meeting venues that are easy to get to (e.g. parking, disabled access). Consider mid-morning or afternoon meetings to allow for travelling time
Offer a pre-meeting telephone call or discussion to prepare patients
Introduce everyone, ensure patients are involved
Avoid jargon and ensure the chairs confirm patient understanding regularly
Take frequent breaks
Allow discussion of potentially upsetting or distressing topics without first preparing patients
Conduct long meetings without breaks or refreshments
Use jargon, technical language or complex diagrams/slides where these can be avoided
Exclude patients from discussions or prevent them from contributing
Finance Ensure expenses are reimbursed fully and promptly so that patients are not left “out of pocket” for long
Rely on patients to know how to access reimbursement systems
Leave patients “out of pocket” for long periods
Publication and dissemination Ensure patients are involved in publications if they have contributed and meet the criteria for authorship
Consider lay versions of important documents
Consider making articles open access so that patients can read them for free
Assume that patients do not want to be involved in publications
Fail to acknowledge patient involvement in journal articles
Leave key articles behind a paywall so that patients cannot access them
Communication Ensure patients have a point of contact who is accessible and responsive
Ensure patients receive feedback on how their involvement is affecting the project(s)
Dismiss any problems or concerns identified by patients
Expect patients to respond to short deadlines or undertake large tasks
Assume patients know who they can talk to for advice or to express concerns
- Table 3
Challenges and solutions from a European Lung Foundation perspective
Project area Specific challenge Solutions implemented Future recommendations Engagement with and management of expectations, project chairs and members ELF to maintain an overview of multiple project actions and deadlines to ensure patient input co-ordinated effectively and with feasible deadlines. Open and regular communication between EMBARC, ELF and patient representatives.
Shared commitment and enthusiasm by all to ensure positive engagement of, and experience for, patients involved in the projects.ELF inclusion in development of project action plans at earliest stage possible. Recruitment of a patient advisory group Larger than usual response to our invitation for patients to get involved in EMBARC projects resulted in >50 members on our bronchiectasis patient advisory group (rather than ∼6–12). Defined the >50 members as a “patient reference panel” for wider consultation at key points during projects. From this panel, we engaged with those individuals who wanted to be more involved in working groups. Potential model for future projects. Benefits of having the wider reference panel:
1)There is a core base of people ready and engaged for consultation at key points;
2)Opportunities for easier recruitment for future projects or if representatives have to drop out due to ill health or other commitments;
3)Wider promotion of project outcomes through the core group.Communication and consultation with wider patient advisory group Ensuring two-way communication between patient representatives attending task force meetings and wider patient advisory panel to ensure that wider views are represented. Development of “Conflict of Interest and Confidentiality” form for patient representatives and patient advisory group members to complete prior to involvement in task forces and projects. Provide clearer guidance and mechanisms for patient representatives to easily give feedback and gather views from the wider patient advisory group. Preparation and training for patient representatives involved in task forces Lack of detailed, written guidance for patient representatives involved in task force meetings. Developed guidance booklet including case study from patient representative involved in this task force. Review guidance and training in light of recommendations raised in this article. Ongoing support for patient representatives Increasing demands on core group of patients as workload increases. Ongoing communication with patient representatives and project chairs throughout the project to highlight potential pressure points. Setting realistic role descriptions, expectations and timelines from the beginning and reviewing these throughout the project. Guidance for task force/project chairs No defined process. Clarification of our patient input process to aid discussions and planning (supplementary material).
Basic guidance for task force chairs developed.Involve patient representatives at initial discussion stage to ensure best patient involvement approaches are used.
Review current guidance for task force chairs, to expand and include a checklist of key responsibilities.
Include recommendations for keeping ELF involved and up to date in project development and timeline.Face-to-face meetings with patient representatives Value of face-to-face meetings recognised but posed some difficulties for individual patients around potential risks; also some technology difficulties encountered. Developed risk protocol document in response to this for use with patients attending face-to-face meetings in future. Ongoing use and review of risk protocol. Evaluation of patient involvement in projects Lack of embedded evaluation processes. Added a question to task force annual review reports about their experience of patient involvement to date, to help capture feedback part-way through the project so can tackle any issues raised.
Piloted an evaluation survey for patient advisory group members at end of project (aim to widen this out to other projects).
Reflection and production of the content for this article.Develop ELF evaluation strategy to identify best ways of capturing experiences of patient involvement, in order to promote high-quality engagement in the future.
Suggest involvement of patients and healthcare professionals in evaluation stages.
Ongoing informal and open communication with patient representatives to encourage the raising of any issues/problems that can be addressed.Ending a project How to acknowledge patient participation at the end of projects. Not yet applicable. Define process for exit strategy for patient representatives when projects end.
Current exploration of maintaining patient advisory groups over longer term.
Supplementary Materials
Supplementary Material
J.D. Chalmers EDU-0095-2017_Chalmers
Related Data
