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What does an old children’s rhyme, a mouse, a clock and a tale of men including migrant workers with learning difficulties, have to do with my research into clinical trial design? The common factor is that “all” of these groups, grannies bouncing babies on their knees, people with learning difficulties, migrant workers, are, like many of us, people who may need medical treatment and can benefit from clinical trials. Sadly, many of them will be excluded.
Trials have been around a long time. Hickory dickory dock is reputed to date from 1744 shortly before James Lind, a ship’s surgeon on board HMS Salisbury, started his famous scurvy trial in 1747. He treated 12 sailors, two in each group with cider, sulphuric acid, usual gruel, sea water, vinegar and oranges and lemons – sailors barely able to walk, lying in their bunks with rotting bleeding gums. After six days, one sailor on oranges and lemons, was fit for duty. And as they say – the rest is history – fresh citrus fruit became part of the staple diet in the Royal Navy.
Enter the mouse – also on the ship. A pure beautiful white mouse is often the first for experimentation to determine if an intervention is safe before trials on humans. From Mice to Men, we progress through early phase trials that test safety and toxicity of a drug in a normal population to calculating safe doses and side effects in a diseased population. All of this work is essential and well regulated to protect patients, but we also need to know if a treatment will work on “all” patients who will ultimately receive the treatment in usual care.
My work has been looking at a tool to help people designing trials (trialists) consider the impact their design decisions have on the applicability of their results in clinical settings. This tool will help a trial team, right at the beginning of the design process to create trials that are more relevant to patients, health professionals and policy makers. So, imagine a clock face…
The clock is split into nine: moving clockwise, trialists consider different aspects of the trial.
- Who is chosen to participate in the trial?
- How are they enrolled into the trial?
- Where is the trial being done?
- What expertise and resources are needed to deliver the treatment?
- How should the treatment be delivered?
- What measures are in place to make sure participants comply?
- How closely are participants monitored?
- How relevant is the outcome or result to participants?
- To what extent are all data included?
If, for instance, the people designing the trial think: everyone who might get the treatment in routine care will get into the trial; and they will be invited when they attend a clinic at their usual health centre or hospital; they could be treated by any of the doctors, nurses, physios; and they go back to see the health care professional as often as usual to measure something important eg improve attention in children with Attention Deficit Disorder; then we have a large coloured in clock. If we move away from the norm, then a smaller clock, with less colouring in.
Over eighty international trialists have helped develop this tool to help trialists think through the who, where, how, when of their trial. The “clock” format is very visual – at a glance, you can tell how much a trial equates to the “real world”, how applicable the results of a trial are to usual care; lots of colour then very like the real world and if not much colour then the trial is looking at specific well controlled ideal conditions for particular people or settings. The trial design tool is fun for trial teams to use using paper or the web; a different way of working, improves discussion through making trial teams aware of the range of opinions and facilitates consensus. It aims for consistency in decision making.
Why is this important? Patient and context are key to determine if a trial can answer the question from a patient, doctor or policymaker’s perspective “Does this help me?” An innovative treatment can be the difference between life and death, consequently clinical trials are deadly serious. And expensive – medical research charities invested over 1.3 billion in UK medical research including trials in 2013. Thus, considering trial design and applicability of trial results has never been more important. We owe it to the British taxpayer to improve the health of the British public with well-designed trials and this tool has an apt acronym PRECIS-2. PRECISely when needed, this tool can help design trials from mice to men that are relevant and fit for purpose.
- PRECIS-2 website www.PRECIS-2.org;
- Article in BMJ http://www.bmj.com/content/350/bmj.h2147.full.pdf+html
- YouTube podcast with Kirsty Loudon and Shaun Treweek https://www.youtube.com/watch?v=Sj7cNCyvHVE
Kirsty Loudon, 7 January 2016
Kirsty Loudon is a Research Fellow with the NMAHP Research Unit at the University of Stirling.
Email: firstname.lastname@example.org Twitter: @
Update of a post published in the College bulletin, University of Aberdeen, July 2015.
The state of maternity care in Scotland has been examined by University of Stirling researchers working with the Scottish Government.
The national report Having a baby in Scotland 2015: Listening to Mothers documents the story of more than 2000 new mothers.
Produced in partnership by the Scottish Government and Stirling’s Nursing, Midwifery and Allied Health Professions Research Unit (NMAHP RU) – it shows women are accessing care earlier in pregnancy with significantly more contacting a midwife first when they are pregnant.
Communication between women and maternity care staff appears to be good with most women reporting that they were listened to, spoken to in ways that they could understand and involved as much as they wanted in decisions about their care. The high level of trust women had in staff was evident, in particular during labour and birth.
Areas where care could be improved – particularly in relation to mental health – were highlighted, based on women’s responses to the survey.
Around one third of women felt that they were not given all the advice they needed about emotional changes they might experience and around one quarter were not given information about who to contact for advice about emotional changes if they needed it.
Additionally 44 percent of women said they did not get enough information to help them decide where to have their baby and 24 percent said they were not offered a choice about where to have their baby.
Report author Helen Cheyne, midwife and Professor of Midwifery Research in the NMAHP Research Unit at the University of Stirling said: “One of the most striking findings was around women’s mental health in the six weeks following birth. A recent report shows that almost a quarter of women who died between six weeks and one year following birth did so from mental health related causes. It is essential that all women and their families know the signs and symptoms of mental health problems following birth and who to contact if these occur.
“The report recommends that NHS Boards should examine whether local maternity and perinatal mental health services meet current best practice recommendations to support maternal mental health. All midwives, health visitors and medical staff caring for pregnant and postnatal women should undertake recognised training to ensure there is support for mothers who experience mental health problems.”
The report from the NMAHP Research Unit concludes with six recommendations including the appointment of post-natal care champions in every maternity hospital, ensuring one to one care of women by skilled midwives throughout labour and birth remains a priority and that all women should have choices about where their antenatal and postnatal care and place of birth happens.
Media enquiries to Corrinne Gallagher, Communications Officer, on 01786 466 687 email@example.com
15 December 2015
One in one hundred people will experience schizophrenia in their lifetime. Schizophrenia can be managed well with a person-centred combination of therapy and medication and an emphasis on recovery. Many of us are likely to know people who are affected by the symptoms of schizophrenia but are still managing to lead fairly ordinary lives.
However, for others living with more severe symptoms, schizophrenia can be a distressing and highly debilitating experience. Symptoms experienced such as hearing voices or seeing things (hallucinations) often fail to respond to medication. Even when antipsychotic medication is effective, the side effects of weight gain, apathy, shaking or lack of drive are also debilitating. More effective drugs are urgently needed, however despite promising leads there has not been ground-breaking progress in drug development for schizophrenia for many decades.
One emerging non-drug therapy proposed for the treatment of schizophrenia and the symptom of hearing voices is transcranial magnetic stimulation (TMS). TMS is a device which involves the skilful application of a strong magnetic field close to the scalp surface. TMS is a relatively painless and non-invasive technique which stimulates parts of the brain. Researchers over the last decade have set about assessing whether this promising new therapy TMS could be an alternative treatment for people who do not respond, or do not cope well with medication.
Researchers have typically used ‘randomised controlled studies’ to assess the effectiveness of TMS. This has usually meant randomising people with schizophrenia – with their full consent – into an experiment of either having TMS or having ‘sham’ TMS (i.e. identical process without the magnet switched on). Therefore, randomised controlled studies are a way of comparing two groups of people with schizophrenia who are as identical as possible in every way except for the active ingredient of the TMS itself.
Although many of these study results have now been reported by researchers across the world, the results differed widely and there was no consensus on whether TMS should be routinely used in practice. Therefore we set out to achieve this consensus by reviewing all the reported TMS studies of schizophrenia using Cochrane methodology (the internationally recognised highest standard of review). The purpose of our Cochrane review was to assess the quality of all reported studies, and then combine the results into one analysis (a ‘meta-analysis’) to give summary estimates of whether TMS is effective, or not.
We found that from 41 reported studies (1473 people) there was some evidence to suggest TMS may improve certain symptoms such as hearing voices when compared with ‘sham’ TMS. However, because we also graded many of the studies as ‘low’ or ‘very low’ quality evidence, this meant we were uncertain that TMS was effective, and could not make firm conclusions about using TMS as routine treatment for schizophrenia.
To be clear, this is not the same as researchers doing low quality studies, but rather that frequently the way the study was conducted was not reported to a sufficient standard to rule out risks of bias. This is frustrating, and authors who are reporting on study results are urged to adopt clear reporting practices to remove ambiguity by using standards such as the CONSORT criteria. Journal editors should consider routinely recommending the use of CONSORT criteria and lift restrictions on word limits which inhibit full reporting.
In future, high quality research studies AND high quality reporting of these studies is very likely to have an important impact on whether we can confirm TMS alleviates some symptoms of schizophrenia, but for now we remain quite uncertain. It is important that the research community pursues this aim so that we can improve the quality of treatment provided to people who are living with the debilitating symptoms of schizophrenia.
1 October 2015
Dougall N, Maayan N, Soares-Weiser K, McDermott LM, McIntosh A. Transcranial magnetic stimulation (TMS) for schizophrenia. Cochrane Database of Systematic Reviews 2015, Issue 8. Art. No.:CD006081.
The two-year project will improve the way researchers use existing qualitative research on health services, to increase the likelihood that it will be used by NHS decision-makers.
The project – titled eMERGe – is funded by the National Institute of Health’s Health Services and Delivery Research Programme. The project involves a partnership with leading academics from the Universities of Edinburgh, Bangor and Cardiff, and working closely with an international group of experts.
Dr Emma France, Senior Lecturer in the Nursing, Midwifery and Allied Health Professions Research Unit (NMAHP RU) based at the University of Stirling, said: “Information about people’s experiences of health services and care should play a major role in improving NHS services, but this kind of data rarely influences decision making.
“Evidence about which treatments and services work is important and already informs health service design, but to create high quality patient-focused health services we also need to consider why and how they work and people’s experiences of using them.”
“Pulling together evidence from many existing qualitative studies, such as those using patient interviews or focus groups, can shed light on factors like why patients or health professionals behave in a certain way, or what it is like to experience an illness.”
The project will focus on the use of a method called meta-ethnography, which is used to combine information from a range of qualitative studies. The team will be working closely with Professor George Noblit from the University of North Carolina, USA, who developed meta-ethnography.
This approach enables researchers to find new insights and conclusions regarding specific health topics, such as people’s experiences of being treated for arthritis.
Dr France said: “Low-quality reporting of meta-ethnographies is common, meaning patient groups, NHS staff and managers often lack trust in the findings and ultimately do not use them to improve decisions, services and patient care.
“The eMERGe project will develop guidelines to assist researchers in carrying out quality meta-ethnographies and reporting them to a high standard, meaning this rich information can be used to create better decision-making and improve outcomes for patients.”
Media enquiries to David Tripp, Communications Officer on 01786 466 687 or firstname.lastname@example.org.
Posted: 16 August 2015
Our recent research highlights the importance of understanding the multiple factors which influence continued smoking in people affected by cancer. It also shows that engaging patients and families in discussion about smoking within the context of a cancer diagnosis is acceptable, but that an individualised and integrated approach to smoking cessation across the whole cancer journey is needed.
Research evidence illustrates the value of cessation for patients’ treatment outcomes, survival and future health. Last month we held two public engagement sessions in Dundee as part of the NMAHP Research Unit’s CSO-funded ‘Cancer & Smoking Cessation Study’. Over the past 18 months this has been exploring key factors likely to increase uptake of smoking cessation services among families, within the context of a recent cancer diagnosis. Researchers Tricia Aitchison and Fiona Harris have conducted more than 65 in-depth interviews with patients, relatives and health professionals in Tayside and Forth Valley.
The ‘Talking about smoking and cancer: Help us design better services’ sessions brought together a range of people. Participants included consultant oncologists, cancer nurse specialists, radiographers, smoking cessation advisors, charity representatives and health promotion staff – as well as a small number of patients and family members who had taken part in interviews for the study. An advert had also been placed in the local Courier newspaper to invite members of the public to attend.
The aim of the public engagement sessions was not only to present key findings from the study but also to provide opportunity for participants to suggest, discuss and evaluate ideas for future interventions. Three short, 10-minute presentations on study findings were followed by small group discussions facilitated by members of the study Steering Group.
The presentations were:
- Talking About Smoking: What patients, family members and health professionals bring to conversations about smoking in the context of cancer;
- Moving from talking about smoking to doing something about it: What happens next? and
- What opportunities are there for intervention and what might these look like?
They certainly seemed to stimulate lots of talking and interaction within the groups!
Our study findings highlight that potential opportunities for talking to patients and families about smoking may often be missed by healthcare professionals. There was consensus among the participants at our event that barriers to discussing and addressing smoking need to be overcome so that patients are given effective cessation advice and support throughout their care journey.
Professor Mary Wells, University of Stirling, School of Health Sciences
4 February 2015
University of Stirling, School of Health Sciences research:
Cystic Fibrosis (CF) is an inherited, life-threatening disorder of the lungs and digestive system affecting approximately 1 in 2,500 children in the UK. Currently, there is no cure for CF so treatment focuses on easing the symptoms which include thick mucus made by the lungs which blocks airways and is associated with severe lung infections.
Chest physiotherapy (CPT) and airway clearance techniques, such as breathing exercises, are a major part of the daily treatment to clear the lungs and airways. The success of CPT is extremely dependent on adherence by the child and parent. Adherence in young children is important because damage occurs rapidly and can be irreversible. However, only 50% of parents and young children adhere to their recommended regimen. Parents and carers and their young children find it difficult to stick to their physiotherapy routine for a wide range of reasons, for example, children find it boring and sometimes painful and uncomfortable and when no mucus is produced by CPT it can be hard for parents to stay motivated.
Despite the importance of CPT and the current high non-adherence rates there is a lack of high-quality, theory-based intervention studies to improve physiotherapy adherence in young children with CF. In this study we are developing and testing an intervention for parents/carers of children with CF aged 0-8 years old likely to increase adherence to physiotherapy. The intervention will have two components:
- An audio-visual support resource (short film) to enhance parental intentions to adhere to physiotherapy;
- A family-specific adherence plan to facilitate the translation of intentions into behavioural change.
Parents and carers of young children with CF are currently taking part in an online ‘SCooP group’ to develop the short film for Stage 1 of the study. In stage 2 of the study 20 parents and carers will try out the intervention to see if it has an impact on their adherence to CPT. If the intervention shows promise, we will then look to conduct a full trial. The multi-disciplinary research team working on the SCooP project brings together academic researchers, clinicians, computer animators, a screen writer, film-makers, psychologists and the Cystic Fibrosis Trust.
PI – Dr Emma France, NMAHP RU, University of Stirling; Dr Gaylor Hoskins, University of Stirling; Professor Brian Williams, University of Stirling; Dr John McGhee, University of New South Wales; Professor Shaun Treweek, University of Aberdeen; Professor Suzanne Hagen, Glasgow Caledonian University; Ms Elaine Dhouieb, Royal Hospital for Sick Children, NHS Lothian; Dr Steve Cunningham, Royal Hospital for Sick Children, NHS Lothian; Dr Claire Glasscoe, Self-employed; Dr Eleanor Main, University College London; Dr Janet Allen, Cystic Fibrosis Trust; Professor Chris Rowland, University of Dundee; Professor Pat Hoddinott, University of Stirling.
*Parents of children with CF voted for the project name ‘SCooP’ and chose the logo.
For further info http://www.stir.ac.uk/scoop/ Email: email@example.com