2018 ATRR: Making a difference: patient and public involvement in tinnitus research

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In recent years, the practice of involving patients and members of the public in designing and conducting research has been gaining momentum. In the UK, government-funding bodies, such as the National Institute for
Health Research (NIHR) and national charities require research proposals to integrate patient involvement throughout the project. The year 2015 saw the launch of a UK-based journal – Research Involvement and Engagement – dedicated to reporting on methods and impacts of patient involvement. In 2017, an international network of like-minded individuals was launched in London [1]. Also in 2017, international guidelines were published on how patient involvement should be reported in scientific journals [2].

It is therefore timely to review take a look at how clinicians and researchers are involving patients and the public in tinnitus research. Through this brief review of the published literature for 2017, we also hope to inspire more researchers and people with tinnitus to join together in the quest to improve tinnitus treatments.

What is Patient and Public Involvement?

Clinicians and researchers typically study health conditions of which they have no direct personal experience as a patient. They may miss identifying what is important to people who are directly affected by the health condition and may not know how best to design research around their needs and priorities. Tinnitus is a personal, subjective experience and the effects can be many and varied. This makes it especially difficult for investigators to understand what is needed.Members of the public with direct experience of the condition can help researchers to bridge this gap, bringing their insights of the condition to the research team. In the UK, this is known as Patient and Public Involvement.

Patient and Public Involvement is where research is ‘carried out with or by members of the public rather than to, about or for them’ [3]. This is distinct from participation, where people take part in a study and their data is included in study findings. For involvement, members of the public or patients with the health condition of interest work as members of the research team to design and deliver the research.

Why should patients and the public be involved?

Patient involvement is important as a matter of principle: people who are affected by research have a right to have a say in what and how publicly funded research is undertaken [4]. Evidence shows that patients can guide investigators to tackle questions that are directly relevant and important. For instance, the James Lind Alliance Priority Setting Partnership for tinnitus, led by the British Tinnitus Association and completed in 2012, identified 10 priority questions agreed by people with tinnitus, and this is now shaping current research strategies [5].
Patient involvement can also have direct benefits to individual studies by:

• highlighting reasons why a study may not be feasible to do
• contributing to the plan for how best to recruit eligible participants
• improving participant information making it more easily readable and more accessible
• improving other aspects of study design to enhance the number of participants willing to take part
• guiding investigators to measure what matters to patients
• bringing a patient viewpoint to interpreting data
• assisting in sharing findings with members of the public.

Patients and the public involved in, and informed by research, may also act as advocates for improving health and social care services [1] [4][6].

What is the purpose of this review?

Patient and public involvement is a growing topic but at the moment it tends to be reported inconsistently and in insufficient detail, with little information about its context, process and impact [1]. This general statement is true for all health fields. Here, we review tinnitus research published in 2017 looking for evidence of whether patient involvement is happening in research (is it being reported?) and if so then what is the nature of that involvement (what is being done?). We will also draw upon the evidence and our own experience to discuss what is required to progress patient involvement in tinnitus research, and what the future holds. The more patient involvement in tinnitus research there is, the louder the voices of people with tinnitus will be.

Academic reports of patient involvement

We searched the academic literature using PubMed, a free search engine of MEDLINE, one of the world’s largest databases of articles in life and biomedical sciences. We sifted through all articles with ‘tinnitus’ in the title and which were classified as clinical studies, reviews, comparative studies, case reports, protocols, evaluation studies or audio-visual media, or which included any of the following keywords in the article text: ‘patient’, ‘public’, ‘consumer’, ‘user’, ‘involvement’, ‘engagement’.

Of the 137 articles identified, only five articles directly reported aspects of patient involvement in the research work, i.e. less than 4%. All 137 articles were grouped together according to the type of study reported and these are shown in Figure 1. The five articles which reported PPI are highlighted in dark blue. Of these five articles, one described a public education campaign, one described the cost of treatment pathways and three were study protocols (description of a planned study). While we must be mindful that some types of studies have more potential for patient involvement than others – for example reviews, systematic reviews and case reports detailing an individual patient are inherently limited – this is a surprisingly low figure.

Figure 1:
Reports of PPI in tinnitus research articles

Public education campaign:

Martin and colleagues [7] documented the delivery of the Dangerous Decibels® hearing loss and tinnitus prevention programme to 9-11 year old children in American Indian communities. The research ran from 2010 to 2016 and the team involved members of the communities in the design, administration and evaluation of the programme. They concluded that such involvement was critical to gaining the approval of community leaders and enabled the programme to be self-sustaining – successfully handing over the teaching and organisational responsibilities to local representatives.

Cost of treatment pathways:

Stockdale and colleagues [8] reported on an evaluation of the cost effectiveness of tinnitus therapy options in the UK, with a view to defining the value of tinnitus therapies. In the context of variable health service provision for tinnitus and increasing pressure on health budgets, this work provides evidence that may help to maintain and improve treatments available. Patients or the public did not appear to be directly involved, but the idea was conceived by the British Tinnitus Association (BTA), representing the interests of people with tinnitus.

Study protocols:

All three protocols described UK-based studies, two of which are funded by the government funding body, the NIHR. The first aimed to evaluate the feasibility of a clinical trial comparing a psychologically informed guidance manual developed to support audiologist management of tinnitus with usual treatment [9]. The project included members of the public with tinnitus in the study team. They were involved in developing the manual alongside other team members, each focussing on their own area of expertise (lived experience or professional) to develop specific sections. However, it is unclear what impact the members of the public had in the final study protocol. Outline plans for involving members of the public in analysing qualitative data were also included. Two members of the public will be subsequently involved in this analysis, each pairing up with a researcher to compare findings [10].

The second described an international online study whose aim is to identify a common standard for assessing and reporting how tinnitus treatments have worked [11]. The study involved two people with tinnitus in the study team, reviewing study documentation and overseeing development of the online study surveys, defining and refining the list of items included. Fourteen members of the BTA Users’ Panel also reviewed item definitions. List items that were modified or combined through patient involvement were named and overall, the number of list items was reduced from 124 to 66. The patient involvement was crucial to ensuring that participants with lived experience of tinnitus had an equal voice. Further details of this project are reported in the article in this review series by Deb Hall.

The final protocol by Beukes and colleagues [12] planned a clinical trial comparing a guided internet-based Cognitive Behavioural Therapy (iCBT) intervention for tinnitus with face-to-face clinical care reports. A ‘public-patient partnership’ has been involved since early development and has assisted with functionality testing and evaluation of the developed iCBT intervention. Patients have had input into the study design and study materials used to ensure that they are patient friendly. The authors stated that their public members will also serve as independent points of contact for participants for impartial advice about the study.

With the exception of [11], the impact of patient involvement is not clearly reported, and of course, for the published protocols the work is on-going. However, from our review it appears that patient involvement in a small number of studies has contributed to identifying the subject of study, reviewed and co-designed participant information, modified a survey, co-developed a new intervention, shaped research in a culturally sensitive manner, opened doors to community participation and strengthened participant recruitment.

Non-academic reports of patient involvement

We also reviewed non-academic sources of tinnitus research-related reports published in2017. We searched TinnitusTalk.com, a patient community of over 20,000 members run by non-profit Tinnitus Hub. Although there were 109 posts under the site’s Research News forum in 2017, our search found only one post relating to patient involvement in research. This was a short description by the Tinnitus Hub Director about his visit to the launch meeting of the European School in Inter-disciplinary Tinnitus (1 August 2017). It is encouraging that Tinnitus Hub is partnering with this EU consortium, but it is unclear whether the primary role of the Tinnitus Hub will be for research involvement or participation or engagement (dissemination). Our own posted query asking if anyone in the forum had worked alongside a research team did not elicit any specific examples [13].

We also searched the BTA online community pages (905 followers), Action on Hearing Loss tinnitus forum, popular social media sites Twitter, Facebook and Reddit’s Tinnitus community. But we found no direct mention of patient involvement (or related terms) in tinnitus research. The BTA highlighted several examples of patient involvement in research through their members’ magazine, Quiet and Annual Conference.

The UK-based charity is developing a ‘Road to a Cure’ mind map to find and display all current areas of tinnitus knowledge to identify gaps for further research. The charity appealed for feedback on its development from members of the public through a questionnaire published in Quiet [14]. At the annual conference in
September, Eldre Beukes presented the iCBT study findings (based on the protocol described above) [15], and Helen Pryce presented the development of a tinnitus treatment decision aid developed with patient input [16].

UK leadership in patient involvement

Our review has shown that patient involvement is directly taking place and being reported rather infrequently. Most of the reports described UK-based studies. The UK leadership is certainly in part attributable to the strong advocacy and infrastructure provided by the NIHR, the main UK funder of health and social care research. We have already mentioned the requirement for research projects to embed patient involvement at the funding application stage. With respect to infrastructure support, the NIHR funds INVOLVE,the national advisory body for patient and public involvement in health and social care research and it also employs dedicated support staff within research-active hospitals. INVOLVE is developing a set of standards for what makes good PPI practice, and an online facility for advertising opportunities for training in patient involvement and for providing relevant resources. INVOLVE also supports a ‘matchmaking’ site website called People in Research (www.peopleinresearch.org.uk). This allows investigators to advertise (at no cost) patient involvement opportunities and the public to search for them. The NIHR provides some open access online training opportunities, such as those available via the FutureLearn website
[17]. And the European Patients’ Academy also offers some online training opportunities [18].

The UK also benefits from an influential network, the Association of Medical Research Charities, which is developing a strong ethos of including the patients’ views in research [19].

Finally, in 2017, a UK-based team published an international guideline for reporting of patient and public involvement in health and social care research in academic publications [20]. The aim here is to improve the quality, transparency, and consistency of the international patient and public involvement evidence base, to ensure that
practice is based on the best evidence (Table 1).

Table 1:
Guidance for Reporting Involvement of Patients and the Public checklist short form [20]

While the UK provides direct support, there are steps that every investigator can take to involve patients in research. Building relationships with interested groups, such as a national charity or local tinnitus support groups, can pay dividends. Offering to give a short presentation about your research or about tinnitus in general may be welcomed and be a springboard to finding people to contribute to your research.

Advertising can be quite simple and inexpensive, including putting up posters in clinics and building a presence on social media. A Twitter or Facebook account dedicated to a particular study can be set up for free, as can posts on online discussion forums. And, of course, researchers who are also clinical practitioners can ask their patients if they would like to be involved. While these suggestions encourage you to ‘have a go’, it is important to appreciate that meaningful patient involvement takes time and effort. Nevertheless, it pays dividends if done well.

Concluding remarks

The tinnitus community has stared on the journey of involving patients in its research but there is still far to go in more widely embedding patient involvement in research as a routine feature of tinnitus research. Recent developments, particularly in the UK, bode well for growing the role of patients as part of the tinnitus research team, so that the patient voice is heard loud and clear.

References

[1] International network for public involvement and engagement in health and social care research. Available at: https://mailchi.mp/4c4c38c6f32f/an-international-network-for-public-involvement-and-engagement-in-health-
and-social-care-research?e=bbb0a9a001.[Accessed 26 February 2018]

[2] Staniszewska S, Brett J, Simera I, Seers K, Mockford C, Goodlad S, et al. GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. Research Involvement and Engagement. 2017: 3:13. doi: 10.1186/s40900-017-0062-2

[3] INVOLVE. What is public involvement in research? 2016. http://www.invo.org.uk/find-out-more/what-is-public-involvement-in-research-2/. Accessed 25 January 2018

[4] INVOLVE. Briefing note three: Why involve members of the public in research? 2018. http:// www.invo.org.uk/posttyperesource/why-should-members-of-the-public-be-involved-in-research/. Accessed 25 January 2018

[5] Hall DA, Mohamad N, Firkins L, Fenton M and Stockdale D. Identifying and prioritizing unmet research questions for people with tinnitus: the James Lind Alliance Tinnitus Priority Setting Partnership. Journal of Clinical Investigation. 2013: 3(1):21-8. doi: 10.4155/cli.12.129

[6] Price A, Albarqouni L, Kirkpatrick J, Clarke M, Liew SM, et al. Patient and public involvement in the design of clinical trials: An overview of systematic reviews. Journal of Evaluation in Clinical Practice. 2017: [Epub ahead of print]. doi: 10.1111/jep.12805

[7] Martin WH, Sobel JL, Griest SE, Howarth LC and Becker TM. Program sustainability: hearing loss and tinnitus prevention in American Indian communities. American Journal of Preventive Medicine. 2017: 52(3S3):S268-S270. doi: 10.1016/j.amepre.2016.10.031

[8] Stockdale D, McFerran D, Brazier P, Pritchard C,Kay T, et al. An economic evaluation of the healthcare cost of tinnitus management in the UK. BMC Health Services Research. 2017: 17(1):577. doi: 10.1186/s12913-017-2527-2

[9] Taylor JA, Hall DA, Walker DM, McMurran M, Casey A, et al. A psychologically informed, audiologist-delivered, manualised intervention for tinnitus: protocol for a randomised controlled feasibility trial (Tin Man study). Pilot and Feasibility Studies. 2017: 3:24. doi: 10.1186/ s40814-017-0137-8. eCollection 2017

[10] Personal communication

[11] Fackrell K, Smith H, Colley V, Thacker B, Horobin A, et al. Core Outcome Domains for early phase clinical trials of sound-, psychology-, and pharmacology-based interventions to manage chronic subjective tinnitus in adults: the COMiT’ID study protocol for using a Delphi process and face-to-face meetings to establish consensus. Trials. 2017: 18(1):388. Doi: 10.1186/s13063-017-2123-0

[12] Beukes EW, Baguley DM, Allen PM, Manchaiah V and Andersson G. Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial. Trials. 2017: 18(1):186.doi: 10.1186/s13063-017-1931-6

[13] https://www.tinnitustalk.com

[14] British Tinnitus Association. Mapping a cure. Quiet. 2017: 28(4): 17-20

[15] Beukes E. Audiologist guided internet-based CBT for tinnitus: feasible, acceptable and effective. British Tinnitus Association 2017 conference, Sheffield, UK. Available at: https://www.tinnitus.org.uk/Event/vconf. [Accessed 26 February 2018]

[16] Pryce H. Sharing decisions in tinnitus: preferences, information and approaches. British Tinnitus Association 2017 conference, Sheffield, UK. Available at: https://www.tinnitus.org.uk/Event/vconf. [Accessed 26 February 2018]

[17] FutureLearn. Improving healthcare through clinical research. Available at: https://www.futurelearn.com/courses/clinical-research [Accessed 26 February 2018]

[18] European Patients’ Academy. Available at: https://www.eupati.eu/ [Accessed 26 February 2018]

[19] Association of Medical Research Charities (AMRC). Patient voice. Available at: https://www.amrc.org.uk/the-patient-voice [Accessed 26 February 2018]

[20] Staniszewska S, Brett J, Simera I, Seers K, Mockford C, Goodlad S et al. GRIPP2 reporting checklists: tools to improve reporting of patientand public involvement in research. BMJ. 2017: 358: j3453

About the authors:

Dr Adele Horobin
Patient and Public Involvement and Engagement Manager

NIHR Nottingham Biomedical Research Centre/ Nottingham University Hospitals NHS Trust

After a role in social care, Dr Adele Horobin completed an MSc in Applied Biomolecular Technology followed by a PhD in Tissue Engineering and Parasitology at the University of Nottingham. After a period of postdoctoral research, Adele moved into the fields of research commercialisation and knowledge management, before moving into her current role in 2013.

Since then, she has founded the East Midlands Lay Assessor Training programme and the East Midlands Sharebank network. Adele is also playing a pivotal role in INVOLVE’s national working group for Learning and Development in patient and public involvement.

Anna Frost

Public Research Partner
NIHR Nottingham Biomedical Research Centre

Anna is a long-standing member of the British Tinnitus Association’s Users’ Panel. She has also held various posts in the private, public and voluntary sectors including General Secretary of the Associated Country Women of the World. She has also worked for the University of London’s Institute of Education and Warburg Institute and the Leukaemia Research Fund. Anna is now a Governor of the British Federation of Women Graduates Charitable Foundation.

Anna is experienced in overseeing grant schemes and developing funding applications. She is trained in PPI and qualitative analysis via the NIHR Nottingham BRC. Anna has built an array of PPI experience through various projects at the NIHR Nottingham BRC. PPI has helped Anna turn her tinnitus into something positive, using her experience to help others, be they clinicians, researchers or patients.