Tag Archives: PPI

Patient and Public Involvement: Direct Involvement of Patient Representatives in Data Collection

It is widely accepted that the public and patient voice should be heard loud and clear in the selection of studies, in the design of those studies, and in the interpretation and dissemination of the findings. But what about involvement of patient and the public in the collection of data? Before science became professionalised, all scientists could have been considered members of the public. Robert Hooke, for example, could have called himself architect, philosopher, physicist, chemist, or just Hooke. Today, the public are involved in data collection in many scientific enterprises. For example, householders frequently contribute data on bird populations, and Prof Brian Cox involved the public in the detection of new planets in his highly acclaimed television series. In medicine, patients have been involved in collecting data; for example patients with primary biliary cirrhosis were the data collectors in a randomised trial.[1] However, the topic of public and patient involvement in data collection is deceptively complex. This is because there are numerous procedural safeguards governing access to users of the health service and that restrict disbursement of the funds that are used to pay for research.

Let us consider first the issue of access to patients. It is not permissible to collect research data without undergoing certain procedural checks; in the UK it is necessary to be ratified by the Disclosure and Barring Service (DBS) and to have necessary permissions from the institutional authorities. You simply cannot walk onto a hospital ward and start handing out questionnaires or collecting blood samples.

Then there is the question of training. Before collecting data from patients it is necessary to be trained in how to do so, covering both salient ethical and scientific principles. Such training is not without its costs, which takes us to the next issue.

Researchers are paid for their work and, irrespective of whether the funds are publically or privately provided, access to payment is governed by fiduciary and equality/diversity legislation and guidelines. Access to scarce resources is usually governed by some sort of competitive selection process.

None of the above should be taken as an argument against patients and the public taking part in data collection. It does, however, mean that this needs to be a carefully managed process. Of course things are very much simpler if access to patients is not required. For example, conducting a literature survey would require only that the person doing it was technically competent and in many cases members of the public would already have all, or some, of the necessary skills. I would be very happy to collaborate with a retired professor of physics (if anyone wants to volunteer!). But that is not the point. The point is that procedural safeguards must be applied, and this entails management structures that can manage the process.

Research may be carried out by accessing members of the public who are not patients, or at least who are not accessed through the health services. As far as I know there are no particular restrictions on doing so, and I guess that such contact is governed by the common law covering issues such as privacy, battery, assault, and so on. The situation becomes different, however, if access is achieved through a health service organisation, or conducted on behalf of an institution, such as a university. Then presumably any member of the public wishing to collect data from other members of the public would fall under the governance arrangements of the relevant institution. The institution would have to ensure not only that the study was ethical, but that the data-collectors had the necessary skills and that funds were disbursed in accordance with the law. Institutions already deploy ‘freelance’ researchers, so I presume that the necessary procedural arrangements are already in place.

This analysis was stimulated by a discussion in the PPI committee of CLAHRC West Midlands, and represents merely my personal reflections based on first principles. It does not represent my final, settled position, let alone that of the CLAHRC WM, or any other institution. Rather it is an invitation for further comment and analysis.

— Richard Lilford, CLAHRC WM Director

Reference:

  1. Browning J, Combes B, Mayo MJ. Long-term efficacy of sertraline as a treatment for cholestatic pruritus in patients with primary biliary cirrhosis. Am J Gastroenterol. 2003; 98: 2736-41.

‘Information is not knowledge’: Communication of Scientific Evidence and how it can help us make the right decisions

Every one of us is required to make many decisions: from small decisions, such as what shoes to wear with an outfit or whether to have a second slice of cake; to larger decisions, such as whether to apply for a new job or what school to send our children to. For decisions where the outcome can have a large impact we don’t want to play a game of ‘blind man’s buff’ and make a decision at random. We do our utmost to ensure that whatever decision we arrive at, it is the right one. We go through a process of getting hold of information from a variety of sources we trust and processing that knowledge to help us make up our minds. And in this digital age, we have access to more information than ever before.

When it comes to our health, we are often invited to be involved in making shared decisions about our own care as patients. Because it’s our health that’s at stake, this can bring pressures of not only making a decision but also making the right decision. Arriving at a wrong decision can have significant consequences, such as over- or under-medication or missing out from advances in medicine. But how do we know how to make those decisions and where do we get our information from? Before we start taking a new course of medication, for example, how can we find out if the drugs are safe and effective, and how can we find out the risks as well as the benefits?

The Academy of Medical Sciences produced a report, ‘Enhancing the use of scientific evidence to judge the potential benefits and harms of medicine’,[1] which examines what changes would be necessary to help patients make better-informed decisions about taking medication. It is often the case that there is robust scientific evidence that can be useful in helping patients and clinicians make the right choices. However, this information can be difficult to find, hard to understand, and cast adrift in a sea of poor-quality or misleading information. With so much information available, some of it conflicting – is it any surprise that in a Medical Information Survey, almost two-thirds of British adults would trust experiences of friends and family compared to data from clinical trials, which only 37% of British adults would trust?[2]

The report offers recommendations on how scientific evidence can be made available to enable people to weigh up the pros and cons of new medications and arrive at a decision they are comfortable with. These recommendations include: using NHS Choices as a ‘go to’ hub of clear, up-to-date information about medications, with information about benefits and risks that is easy to understand; improving the design, layout and content of patient information leaflets; giving patients longer appointment times so they can have more detailed discussions about medications with their GP; and a traffic-light system to be used by the media to endorse the reliability of scientific evidence.

This is all good news for anyone having to decide whether to start taking a new drug. I would welcome the facility of going to a well-designed website with clear information about the risks and benefits of taking particular drugs rather than my current approach of asking friends and family (most of whom aren’t medically trained), searching online, and reading drug information leaflets that primarily present long lists of side-effects.

Surely this call for clear, accessible information about scientific evidence is just as relevant to all areas of medical research, including applied health. Patients and the public have a right to know how scientific evidence underpinning important decisions in care is generated and to be able to understand that information. Not only do patients and the public also make decisions about aspects of their care, such as whether to give birth at home or in hospital, or whether to take a day off work to attend a health check, but they should also be able to find and understand evidence that explains why care is delivered in a particular way, such as why many GPs now use a telephone triage system before booking in-person appointments. Researchers, clinicians, patients and communicators of research all have a part to play.

In CLAHRC West Midlands, we’re trying to ‘do our bit’. We aim to make accessible a sound body of scientific knowledge through different information channels and our efforts include:

  • Involving patients and the public to write lay summaries of our research projects on our website so people can find out about the research we do.
  • Communication of research evidence in accessible formats, such as CLAHRC BITEs, which are reviewed by our Public Advisors.
  • Method Matters, a series aimed to give members of the public a better understanding of concepts in Applied Health Research.

The recommendations from the Academy of Medical Sciences can provide a useful starting point for further discussions on how we can communicate effectively in applied health research and ensure that scientific evidence, rather than media hype or incomplete or incorrect information, is the basis for decision-making.

— Magdalena Skrybant, CLAHRC WM PPIE Lead

References:

  1. The Academy of Medical Sciences. Enhancing the use of scientific evidence to judge the potential benefits and harms of medicine. London: Academy of Medical Sciences; 2017.
  2. The Academy of Medical Sciences. Academy of Medical Sciences: Medical Information Survey. London: Academy of Medical Sciences; 2016

The Evolving Role of the CLAHRC in the Use of Evidence to Improve Care and Outcomes in Service Settings

If we are to use public funds to support research, there is an assumption that the outcome of that research will be improvements to the service. This exchange, however is problematic. CLAHRCs are set up to address this interface in a particular way, namely to evaluate service interventions. As well as generating new knowledge for the system, there is a wider aspiration of building a system-wide ‘habit’ of using evidence to drive service change and evaluating the output.

As part of the consideration of how CLAHRC West Midlands evolves, we would like to hear readers’ views as to how well it has done and what it should do in the future.

The use of evidence to improve practice in service settings has demand and supply side factors. The service has to want to use evidence, be supported to use evidence, and have the capacity to make changes in response. On the research ‘supply’ side, there has to be a suitable body of existing evidence, researchers have to have the skills and capacity to develop suitable research methods and to convey the outcomes in a usable form.

Even if all these factors co-exist, barriers, such as changed external environments, resistance to change, and timing issues, can thwart the exchange.

CLAHRC WM has tried to address this in a number of ways. It has created new roles:

  • Embedded posts: academic researchers jointly funded by service and research institutions, working on agreed projects within a service setting
  • Diffusion fellows: experienced practitioners supported to undertake research in a service area.

Patients and the public are central to driving the direction of research: their involvement at all stages of the research cycle means that topics are relevant to them and meet their needs. In addition, CLAHRC WM has employed a range of dissemination methods, both traditional and innovative, to share research findings. These include publishing summaries of evaluations completed, running workshops and, indeed, regular publication of this articles in this blog.

Service evaluation is not the only form of research being undertaken within service institutions, nor is CLAHRC WM the only source of evaluation support. With the current focus on integration, there is a question as to how CLAHRC WM could be better integrated within the service’s own research and development strategies. However, one has to be mindful that the budget for CLAHRC WM is tiny compared to the billions of health care spent in the West Midlands each year and therefore it has to take care to target its resources.

In future blogs we will look more closely at some of these issues, with interviews with those occupying embedded/ diffusion roles. Meanwhile, we would welcome your views and thoughts as to how CLAHRC WM should evolve in this regard, so please comment or get in touch; it would be much appreciated.

— Denise McLellan

From Global to Local: How Patient and Public Involvement is Shaping Mental Health Services in CLAHRC West Midlands

Each year, World Mental Health day draws attention to the many issues people with mental health issues need to overcome on a daily basis. Although there are effective treatments for mental health disorders, such as medication and therapies, it is important that people can access the right care at the right time.

There are many stigmas associated with having a mental health disorder, which impact on people disclosing that they have a problem in the first place and then accessing the right treatment as early as possible. In the UK, NICE quality guidelines, which were informed by research undertaken by CLAHRC WM, recommend that 50% of people of all ages who experience psychotic symptoms for the first time should be treated with a NICE approved care package within two weeks of a referral. However, researchers in CLAHRC WM’s Prevention and Early Intervention in Youth Mental Health theme found that young people were not always accessing the services they needed, particularly as they were making the transition from child to adult mental health services. This was due to a number of reasons, including poor help-seeking behaviour, and bottlenecks in specialist mental health services. You can read more about this research here.

Having identified a need to improve access for mental health services for young people in the region, CLAHRC WM researchers work in partnership with patient and public advisers to deliver research that is both meaningful and accessible to them. In particular, CLAHRC WM researchers work with existing patient and public groups in the region to co-design and develop services that are appropriate for the young people that will use them. These groups included the Young Person’s Advisory Group, facilitated by the Clinical Research Network, and the Youth Board (recently renamed Ripple), a group of people aged 16-25 years old, some of whom have lived experiences of mental health issues.

As with all projects within CLAHRC WM, patients and the public can work with researchers in all stages of the research cycle: from coming up with ideas of what research to do, right through to making sense of research findings and sharing these with relevant networks. Readers of the News Blog will have read about how researchers and young people worked with primary care and Child and Adolescent Mental Health Services (CAMHS) to create an effective and appropriate youth clinical service to meet local needs, reduce delays, improve transitions between services, and adopt a preventative triaged intervention model. This new service is delivered by the Forward Thinking Birmingham Partnership.

Young people working in partnership with CLAHRC WM are essential to ensuring that the services both meet the needs of the people who will use them, and are also designed in the right way. Some examples of how CLAHRC WM has involved patients and the public are:

  • Designing and developing www.youthspace.me, an online resource that offers relevant, up-to-date information and advice for young people and their families on all aspects of mental health. Young people helped to design the pages, write content and ensure that the language is accessible.
  • Helping to raise awareness of mental health issues through designing materials for public campaigns such as ‘Don’t Stay Silent’ and ‘Don’t turn your back on the symptoms of psychosis’.
  • Celebrating the successes of the new care pathway through ‘Shout Out for Youth Mental Health’, an event held in Birmingham on 7 June 2016. Young people had an active role in planning the day and facilitating the sessions. Challenges of living with mental health disorders were brought to life through dance and poetry performances by young people, and young people’s willingness to share their experiences emphasised the need to ensure mental health services are accessible and acceptable. You can read more about the event here.
  • Participating in an educational randomised controlled trial in secondary schools across Birmingham to reduce stigma and increase mental health literacy in young people.

Researchers in CLAHRC WM’s Youth Mental Health theme work with Patient and Public Advisers, Barry Clark, Keith Elder and Richard Grant, to ensure that benefits of working with patients and the public in research are maximised. Bringing a wealth of experience and knowledge, our Advisers have not only helped to shape PPI strategies within the theme, but have engaged local networks and communities about the research undertaken by CLAHRC WM in youth mental health. Working in partnership with patient and public advisers ensures that key findings from research are accessible and have impact.

One of the current projects underway in the Youth Mental Health theme is SchoolSpace, a partnership with CLAHRC WM researchers and schools to understand the factors which precede the onset of eating disorders. With growing need for schools to concern themselves with the well-being of their students, researchers in CLAHRC WM are working with schools to design effective screening tools and interventions for teachers and those who work with young people. Our PPI Advisers have worked closely with researchers to help ensure the successful development and implementation of SchoolSpace.

On World Mental Health day, some of the twitter hashtags were #timetotalk and #timetochange. CLAHRC WM researchers are doing their bit by talking and listening to people that use the services and working in partnership with them to deliver change. By working ‘with’ young people, patients and the public, rather than ‘to’ or ‘for’ them, CLAHRC WM has demonstrated the value of meaningful patient and public involvement. Not only is the research undertaken relevant: people using the service have had a key input into the way research is shaped and delivered. Involving people at every stage at the research cycle has benefits including healthy participation rates and widespread dissemination. Most importantly, partnership with patients and the public has led to outcomes that are suitable and of benefit to people using the service, resulting in better care. CLAHRC WM is doing its utmost to ensure that we are removing stigmas to mental health and enabling people to access the right treatments and therapies as soon as possible.

Public and the Patients Making a Difference to World-Class Research

“People-focused research in the NHS simply cannot be delivered without the involvement of patients and the public. No matter how complicated the research or how brilliant the researcher, patients and the public always offer unique, invaluable insights.” (Professor Dame Sally Davies)

The NIHR, under the leadership of Professor Dame Sally Davies, has championed patient and public involvement, engagement and participation. The NIHR aims to improve the health and wealth of the nation through world-class research, and strong and meaningful patient and public involvement is integral to this.

The tenth anniversary celebrations for the NIHR present a valuable opportunity to reflect on how patients and the public make a difference to research. Whilst great steps have been taken to ensuring that patients and the public are involved, participate and engage with research, the journey to achieving a meaningful partnership between patients, the public and researchers is a long one, with obstacles still to be overcome.

In order to take stock of the progress already made with regard to patient and public involvement, engagement and participation, the NIHR commissioned Simon Denegri, Chair of INVOLVE and the NIHR National Director for Patients and the Public, to convene the ‘Breaking Boundaries Review Panel’. The final report, ‘Going the Extra Mile’, was published nine months later, setting out a clear vision for the direction of patient and public involvement, participation and engagement. The strategy is clear:
“Within the NIHR, such is the extent to which the public have become involved that research is increasingly becoming a joint venture between patients and the public, researchers, clinicians and health professionals. If we are to meet the health and social challenges of the future then these partners must be empowered, encouraged and supported to work even closer together.” (Breaking Boundaries, p.8)

Part of this vision is ensuring that patient and public involvement and engagement is meaningful and that developing close relations with patients and the public is second nature to the research community. Patients and the public can be involved at all stages of the research cycle, and by involving and engaging with patients and the public, researchers can ensure that research is relevant, acceptable and appropriate.

From the outset, CLAHRC West Midlands has demonstrated a clear commitment to working in partnership with patients and the public. Our PPI Advisors are represented on each of CLAHRC WM’s themes and the patient and public voice is heard on Steering and Executive Committee level through representatives elected by CLAHRC WM’s Advisors. The PPI Advisors have their own Advisory group, which has developed its own Terms of Reference, and the Advisory group meetings are a useful forum to exchange ideas and share good practice. CLAHRC WM is constantly exploring new ways of involving and engaging with patients and the public: this very news blog now has a dedicated ‘PPI Section’ and the website has been developed with PPI Advisors to make it more accessible. In particular, our PPI representatives are selected at competitive interview. Wherever possible we appoint representatives who also advise the NHS in carrying out its statutory obligation to consult on service change. In this way we seek to line up service change and research – our CLAHRC is driven by service change, so it makes little sense to separate the patients and public who advise on the service from those who would advise on the research – the service change and the research are integrated so the advice should also be integrated.

Having strong patient and public involvement and engagement embedded in each of its themes and present at all organisational levels helps CLAHRC West Midlands to produce world-class research. CLARHC WM’s projects demonstrate the different ways patients and the public can work in partnership with researchers at all stages of the research cycle. From working with researchers before a project even starts to ensure that the right questions are being asked right through to helping disseminate findings to wider audiences when projects finish: patients and the public are involved in all stages of the research cycle.

CLAHRC West Midlands is committed to sharing its knowledge and experience about patient and public involvement through regional and national networks (such as PILAR) and by publishing examples of how researchers have worked meaningfully with patients and the public to achieve better outcomes. But although CLAHRC WM is already demonstrates areas of good practice in working in partnership with patients and the public, it’s important not to rest on our laurels. CLAHRC WM should explore new ways of ensuring meaningful participation, engagement and involvement with patients and the public. CLAHRC WM should make sure that it makes best use of the ‘added value’ patients and the public can bring to research projects and should also seek to overcome some of the barriers to achieving meaningful patient and public involvement and engagement, and be creative and innovative in its approach.

Tennis player Arthur Ashe stated: “Start where you are. Use what you have. Do what you can.” PPI in CLAHRC WM is built on strong foundations and we have some excellent resources to draw upon. We should now do ‘whatever we can’ to ensure patients and the public continue to make a real difference to our world-class research.

— Magdalena Skrybant, PPIE Lead

 

 

 

 

 

Using Real-Time Simulation to Improve the Dialogue when Discussing Women’s Options for Place of Birth

CLAHRC WM Theme 1, Maternity and Child Health, has been involved in carrying out some simulation training with midwives as part of their ‘place of birth’ study. This study has explored midwives’ views of their discussions with women about their options for where to give birth and followed on from the 2011 Birthplace study,[1] which found that for low risk, multiparous women, there was no significant difference in composite perinatal outcomes between women who gave birth in obstetric units, in maternity led units, or at home. Despite this, many women are not offered the full range of birth place options by their midwife and are often unaware that they have a choice about where they can choose to give birth, instead viewing hospital as the ‘default’ option.[2] The ‘place of birth’ study aimed to help promote choice of place of birth in midwives’ discussions with women. This involved a co-production approach, with midwives being involved in the study process and design. Findings from the literature, focus groups with midwives and a preliminary midwifery workshop resulted in identification of the need for a pragmatic, standardised ‘place of birth’ dialogue, that midwives could use as a tool for use in their discussions with women about where to give birth. A provisional draft of this dialogue was put together by midwives working at BWNFT (with input and guidance from the CLAHRC team) and covered aspects relating to the safety and practicalities of giving birth at home, in the Birth Centre and in Delivery Suite. It aimed to use appropriate language and openers so that women would consider all three of the birth place options available to them.

We decided to use role players in a second midwifery and PPI workshop to simulate the interactions between a midwife and a woman when using the dialogue. This was to explore how well the dialogue worked in ‘real’ practice and whether it sounded right or needed amending. At the workshop, two female role players acted out the dialogue (one playing a midwife and one a pregnant woman) and workshop attendees had the opportunity to modify the dialogue based on what sounded and felt right and what didn’t, until a finalised dialogue for multiparous women was agreed on. This process was repeated again, but for nulliparous women, resulting in the formation of two slightly different dialogues, due to differences in safety and risk meaning that slightly different information needed to be conveyed.

The role playing and subsequent discussions were audio recorded to allow any changes to the dialogue which were agreed on to be saved and transcribed. This ensured that a precise final dialogue could be written up by the CLAHRC team, which accurately detailed what was agreed on by the midwives and PPI during the workshop session. This finalised dialogue is intended as a prompt and a supportive tool to convey the sort of information midwives should be giving to women when talking to them about their place of birth options, rather than a script which midwives have to rigidly stick to. However, the final dialogue should convey a true reflection of what works in practice, to provide a useful resource to midwives when thinking about how to approach these discussions.

The role playing was very well received by the midwives and PPI representatives and encouraged interaction, discussion and debate as to the best way to approach place of birth discussions with women. Having the role players present at the workshop meant that any suggested changes to the dialogue could be incorporated and re-enacted by the role players, until a version of the dialogue emerged that had been developed and refined by the midwives who will be using the dialogue in their everyday practice.

The CLAHRC team are continuing to work with midwives at BWNFT to think about the best ways of successfully implementing the place of birth dialogue into midwives everyday practice. We have utilised the COM-B framework [3] to identify a variety of behaviour change techniques that might be useful mechanisms to help embed the dialogue in the short and longer term. We are currently finalising a protocol to support the implementation of the place of birth dialogue in clinical practice and to evaluate how successful it has been in changing the way that midwives talk to women about their options for where to give birth.

— Catherine Shneerson, Research Fellow, CLAHRC WM Theme 1

References

  1. Birthplace in England Collaborative Group. Perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the Birthplace in England national prospective cohort study. BMJ 2011; 343: d7400
  2. Coxon K, Sandall J, Fulop N J. To what extent are women free to choose where to give birth? How discourses of risk, blame and responsibility influence birth place decisionsHealth, Risk & Society. 2014; 16(1): 52-67.
  3. Michie S, van Stralen M, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventionsImplement Sci. 2011; 6: 42.