NMAHP Research Unit ebulletin Jan/Feb 2017
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PREVPROL: preventing prolapse

Lancet paper reports intervention effectiveness

Suzanne HagenWhat would you want to know if you were worried about a feeling of bulging or “something coming down” in your vaginal area? Research evidence can help affected women, healthcare professionals and the NHS make better decisions around what to do about pelvic organ prolapse and when to do it. The Unit’s Suzanne Hagen is on a long-term mission to find out what interventions are effective to treat prolapse, and to prevent it from developing. The importance of the problem and the quality of her group’s ongoing research has led to a second publication in The Lancet. Suzanne says, “Our paper reports on PREVPROL, a randomised controlled trial with large numbers of women in the UK and New Zealand who, many years after childbirth, had early signs of prolapse but hadn’t asked for treatment. As a potential preventative measure, half were randomly chosen to be offered pelvic floor muscle training, while the other half were given a simple advice leaflet that focused on factors such as weight loss, smoking cessation and avoiding heavy lifting. Two years later, there was a small but important reduction in symptoms in the pelvic floor muscle training group, with fewer of these women going to their GP for help relating to prolapse.”

Writing a paper for publication is challenging because there is always far more information that could go in than there is space. Suzanne and her colleagues had to include arguments for the size and importance of the problem, and for their recruitment methods, power calculations, choice of tools for measuring prolapse severity and impact, and the cost and make-up of the intervention (which included specialist physiotherapy, modified Pilates classes and advice on home exercise practice). They also had to show how they had reduced the kind of bias that can influence study findings – for example, although women knew whether they were in the intervention or control group, those entering the data for analysis did not. 

When a paper is submitted to a prestigious journal such as The Lancet, it goes through a tough peer review process. In this case, five other researchers tested every claim and shone a light on every possible limitation of the study design, process and reporting. This external advice was then discussed by the Lancet’s editorial team. As well as providing complimentary feedback, this external review helped Suzanne and her co-authors improve the clarity of their message.  

Suzanne says, “Pelvic floor muscle training is safe and can be done easily by most women as long as they have one-to-one teaching. Although the difference between the groups in prolapse symptom severity two years after intervention was small, we were able to argue that this is clinically important as a preventative measure, as well as statistically significant. We suggest it should be recommended to women by doctors, midwives, health visitors, practice nurses and physiotherapists, even before symptoms become bothersome. We are doing further research on longer term outcomes and women’s experiences of the intervention, and look forward to reporting this in due course.” 

The study on which the Lancet paper was based was funded by Wellbeing of Women, a UK charity which funds research into women’s reproductive health and childbirth. Comments from participants confirm why this type of research is so important:

"Taking part has helped me realise some of the effects childbirth and ageing has had on my body and how I need to look after myself to ensure I keep fit and healthy. I feel more positive about ageing / menopause – it is always good to know that you are not the only one going through something. I have benefited physically and mentally."

"Since taking part in the study and attending both 1:1 physiotherapy sessions and group Pilates there has been a noticeable difference to the incontinence I was experiencing. I am now more confident when going out, no longer need to plan journeys around toilets. This has made so much difference to my quality of life. Talking to friends and work colleagues, it's amazing how many other women are suffering in silence as they are too embarrassed to go to their GP."

Parkinson's communication:

PDCOMM trial under way across the UK

Around two thirds of people with Parkinson’s disease experience speech-related problems, which can have a huge impact on any relationship or activity that depends on communication. While individuals may find speech and language therapy helpful, there is little evidence to support intervention packages or component parts. The UK-wide PDCOMM trial - which has just started in Scotland – will address this knowledge gap by comparing three types of intervention: Lee Silverman Voice Treatment, standard NHS speech and language therapy, and no speech and language therapy intervention. The Unit’s Marian Brady explains, “We have an excellent team working on this NIHR-funded trial, and are addressing real priorities of patients and healthcare professionals. Our robust pilot study – the largest in the field - showed it would be feasible and acceptable to run a phase III randomised controlled trial in this way. As only one area of Scotland was involved in the pilot, we are looking forward to including many more services and people with Parkinson’s disease across the country over the next few years.”

Although guidelines state that speech and language therapy should be available for people with Parkinson’s disease, this is not always the case. When people do access the service, speech and language therapists aim to help them be heard and be clear. Standard NHS intervention uses a variety of techniques including breathing from the diaphragm, controlling the rate of speech, strategies for recalling words, and voice strengthening or speech clarity exercises. Lee Silverman Voice Treatment has one intense focus, to ‘think loud’, with structured exercises all directly addressing this idea.

PDCOMM is a multi-centre randomised controlled trial to compare clinical and cost-effectiveness of its two intervention and control arms. Funded by the National Institute for Health Research through the Health Technology Assessment Programme, it incorporates a process evaluation to help the research team explain how and why the outcomes might vary in different contexts. The trial team, headed up by Catherine Sackley, includes Birmingham Clinical Trials Unit who already have extensive experience of evaluating complex interventions for other Parkinson’s disease symptoms.
Critical care recovery website

Click on the image to see a short video where patients, family members and healthcare professionals explain how, why, when and for whom the website is helpful


Supporting critical care recovery:

Localised online resource for patients and families

A stay in intensive care or high dependency can be an overwhelming and surreal experience for patients and families, with long-lasting effects. Working with patients and colleagues, Dr Pam Ramsay has developed an online resource to support people in their critical care recovery journey. Following a positive evaluation by patients, families and healthcare professionals at the Royal Infirmary of Edinburgh, the website will be spread to another eight Scottish Intensive Care Units. Pam says, “The website was based on over 120 interviews with people who know what it’s like to go through a critical illness. We aimed to capture the breadth of information they had wanted at different points of their journey: intensive care, general hospital wards, getting home, and moving on. Just as important, we tried to organise it so it’s easy for patients and families to find what they need, when they need it, and to save this in a personal ‘scrapbook’ that they can go back to any time.”

Patients, family members and healthcare professionals all feature in a short video giving their reactions to the website. One man, John, refers to the “humanity” in the way it was developed, thanks to the genuine involvement of patients who gave “a different insight into what might be needed”. Throughout, patients discuss how the website provides reliable and relevant information, gives confidence that what they’re experiencing is not unusual, and points to services that people might be missing out on, such as childcare, financial or carer support, activities like walking football, and opportunities for volunteering. Staff also explain how they have used it to support relatives, for example by helping them access chaplaincy services.

Pam created the critical care recovery website with colleagues at the University of Edinburgh, NHS Lothian, and a small digital company, Shaw online solutions. The Health Foundation and Technology Enabled Care are funding the next stage. The eight intensive care units will have their own website, based on the original, but with easily understandable information tailored to the local service and community. This will include transport, visiting times, clinical specialities (such as liver transplant or neurology) and sources of support beyond the NHS.
As one of our clinical re-engagement research fellows, Pam is funded nationally by the Chief Nursing Officer through a scheme administered by NMAHP-RU. This support for clinical academic careers enables NHS Scotland nurses and midwives who have significant previous research experience to develop a programme of research around an important problem in their clinical practice.

Making trials fit for purpose internationally:

Increasing impact of PRECIS-2 tool

Kirsty LoudonComplex interventions used by healthcare professionals are often evaluated in clinical trials, but how useful are the results outside a trial context? Researchers around the globe are gearing up for the 4th International Clinical Trials Methodology Conference (ICTMC 2017) where they will share and debate the latest advances in how trials are designed and conducted. With a workshop and three posters accepted, our Impact Fellow Kirsty Loudon is looking forward to extending awareness of the PRECIS-2 tool, which helps trialists think through design decisions to make sure their results will be relevant to the intended users – policymakers, healthcare professionals and patients. Kirsty is also celebrating a contract with the United States National Institutes of Health who are running a project to apply PRECIS-2 to particular types of trial. She says, “We created PRECIS-2 to improve applicability of trial research, and the NIH project should give greater insight into its usefulness for particular types of real-world study - cluster randomised and implementation trials. NIH is the largest funder of healthcare research in the world, and the subject of these trials - the use of complex interventions to prevent and treat cancer – matters to everyone, so I am absolutely delighted.”

While working internationally is exciting, it presents linguistic challenges. The NIH contract experience reminded Kirsty of her Graduate Management Admission Test for Emory University, which taught her that American and UK English are very different. She says, “Even the contract name was unusual to me, as it was called ‘a professional services purchase order’! More to the point, the project title refers to ‘multi-level’ trials which means the interventions are implemented at the individual, clinician, health centre or institutional level. The term ‘cluster randomised trials’ is more familiar to those of us in the UK.”

PRECIS-2 (Pragmatic Explanatory Continuum Indicator Summary tool) was developed and validated with over 80 international trialists, clinicians, and policymakers to make trials fit for purpose. A BMJ paper in 2015 was named by the UK’s National Institute of Health Research as one of eight “useful papers” for trialists, and it has also been recommended by the Irish Review Board to support grant applications.

The interactive workshop at ICTMC 2017 will give participants hands-on experience in small groups of applying the tool to a trial and communicating their findings through scoring the 9 domains (such as eligibility, primary outcome, and flexibility of delivery) from 1 (intervention is tested under ideal conditions) to 5 (intervention is tested under usual conditions of practice). Designs with ideal conditions are at the explanatory end of the continuum, while those with usual conditions are at the pragmatic end. Each group will feed back on how the group scored each domain, difficulties they encountered, and anything they would like to discuss. In addition to presentations on using the tool, the workshop will conclude with a panel discussion with questions from the audience. 

The 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials will be in Liverpool from 7-10 May 2017. The workshop ‘PRECIS-2: Precisely how can this tool help investigators design trials to achieve practical answers to ‘real world’ questions?’ will be facilitated by Kirsty with Shaun Treweek, Paula Darby Lipman, Gordon Forbes and Andrew Cook.

Professor Marian Brady receives the Robin Tavistock Award 2016 from The Hon. Nicole Campbell

The Robin Tavistock Award is presented annually to a person or group who has made a significant contribution in the field of aphasia (impairment of language and communication as a result of a stroke). Marian Brady was honoured to receive the 2016 Award from Tavistock Trust for Aphasia Trustee The Hon. Nicole Campbell at the International Aphasia Rehabilitation Conference in London in December. She is now looking forward to giving the welcome address at the Collaboration of Aphasia Trialists conference from 8-9 February 2017 in Rotterdam. The Unit will be well represented, with Myzoon Ali also presenting on I-PRAISE (International Practice-based Rehabilitation approaches to AphasIa after StrokE), and Louise Williams talking about RELEASE (REhabilitation and recovery of peopLE with Aphasia after StrokE). Registration is open until 1 February. 

Developing complex interventions:

New Unit researcher goes in at the deep end

Nikki RousseauA warm welcome to Nikki Rousseau, who has joined the Unit as a qualitative researcher on the mixed methods INDEX study. INDEX (IdeNtifying and critiquing different approaches to Developing complEX interventions) is funded by the MRC to produce comprehensive guidance so that intervention developers can base their decision making on the best available evidence. Nikki commented, “I’m delighted to be working with Pat Hoddinott, Eddie Duncan and the wider INDEX team on this exciting project, and keen to get going with my first task – qualitative interviews with researchers and funding panel members to understand the challenges of intervention development. I’m looking forward to hearing how research teams go beyond the ‘headlines’. For example, the intention might be for the intervention to be informed by evidence, theory and / or via co-design, but what happens in practice, particularly when some of these elements might appear to be in opposition? Also, what pitfalls do teams face in developing complex interventions, and how can we help other teams avoid them?”

Before Nikki came to NMAHP RU, she worked as an advisor and methodologist for the NIHR Research Design Service (RDS). The RDS provides design and methodological advice to researchers in England applying for research funding for health and social care research. Nikki explained that, as an advisor, developmental studies were particularly challenging because of the lack of guidance or consensus as to which methods were appropriate in different circumstances.

As Nikki leads a number of qualitative process evaluations alongside randomised controlled trials (including Liteform and TUBE for patients with head and neck cancer), she was aware of previous work members of the INDEX team had done on qualitative research in trials and keen to be involved. As a mixed methods study, INDEX has a number of elements to help identify the key issues for intervention development. A systematic mapping review led by researchers in Sheffield is well under way. In addition to the qualitative interview study (led by Pat Hoddinott and with Katrina Turner from the Department of Primary Care, University of Bristol), Nikki will be involved in an E-Delphi survey led by Eddie Duncan and Lucy Yardley (University of Southampton).

Looking ahead, Nikki said, “I’m keen to see how the various strands of INDEX - the review, the interviews, the E-Delphi survey - are all brought together to provide much needed guidance for researchers. We will be contacting researchers over the next few months to invite their participation in the interviews, E-Delphi study and consensus workshop and are hoping for a good response.” Meanwhile, as a keen (“though not very fast”) swimmer, Nikki has enjoyed exchanging the cold, smelly and murky waters of the Great North Swim for the luxury of Stirling University’s 50m pool!
Margaret MaxwellThe Nursing, Midwifery and Allied Health Professions Research Unit is based at the University of Stirling and Glasgow Caledonian University. Led by Director Margaret Maxwell, Unit staff work with practitioners, researchers and NHS patients and carers to produce research that can inform and improve healthcare. A key aim of the Unit is to contribute to the development of researchers across the nursing, midwifery and allied health professions. Contact us for more information.
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