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NIHR CLAHRC West Midlands News Blog header
This work is funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) West Midlands. 
The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health
National Institute for Health Research logo
Welcome to the latest issue of your NIHR CLAHRC West Midlands News Blog.
Richard Lilford in Édouard Manet's 'A Bar at the Folies-Bergère'
In the latest issue of our News Blog we look at two recent approaches to calculating sample size for qualitative studies. We also look at recent papers on the genetic processes underlying schizophrenia; the return on investment from vaccines in LMICs; an experimental study of income inequality in Kenya; the use of Statistical Process Control; and the replication of original studies.

Further, we bring you a PPI opportunity; summarise our recent workshop on setting up research in the NHS; the latest news; highlight upcoming events; profile Celia Taylor; and have our CLAHRC WM Quiz. Finally, we list some of our latest publications and share some recent Tweets.

We hope that you find these posts of interest, and we welcome any comments. You can find previous issues of our News Blog here.
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 Director's Blog

Sample Size for Qualitative Studies: Two Recent Approaches

Setting sample sizes for quantitative studies can be done in an explicit way by means of calculations based on the concept of precision and a specified effect size (ideally based on a loss function).[1] But qualitative studies are vague, based on notions of ‘theoretical saturation’. Problems:
  1. How much information is needed to satisfy the theory?
  2. How do you know how much information will be provided in the average encounter with an informant?
A small contribution to ameliorating the latter problem comes from the idea of the expected ‘information content’ of each encounter.[2] The authors identify five factors that determine this quantity:
  1. Aim. The broader the aim, the larger the sample of encounters needed.
  2. Salient knowledge of people in the sample. The greater their knowledge, the smaller the required sample.
  3. The extent to which theory is already established. The more developed the theory, the smaller the required sample.
  4. The quality of likely dialogue. The more articulate the respondents, the smaller the sample size.
  5. Analysis type. An exploratory cross-case study requires larger samples than an in-depth analysis of a few, well selected, respondents.
Certainly a useful paper and aide mémoire. However, translation into the actual sample size required remains, let’s be honest, informed guesswork.

The CLAHRC WM Director is attracted to an earlier paper by Fugard and Potts,[3] not referenced in the Malterud, et al. paper. The earlier paper proposed a logical calculation based on the three critical determinants:
  1. The expected prevalence, among respondents, of the least prevalent theme – this should be based on an explicit estimate of the prevalence of the least prevalent theme that the study should be capable of uncovering.
  2. The number of desired instances of the theme.
  3. The power of the study – the probability of detecting sufficient themes of the desired prevalence.
For example, to have an 80% power to detect two instances of a theme with a prevalence of 10% among encounters, 29 informants are required. Now that makes sense. This method has the considerable advantage of requiring the researcher to specify the prevalence of the theme that should not be missed in the sample. The CLAHRC WM Director would like to see this quantitative thinking incorporated and routinely used in planning qualitative research. He will write more generally on some of the problems in the way qualitative research is routinely framed in a future post.

-- Richard Lilford, CLAHRC WM Director

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References

Question
CLAHRC WM Quiz
Which mosquito-borne disease can be transmitted via semen?
 
Email CLAHRC WM your answer.
Answer to our previous quiz: The first woman to gain a medical qualification in Britain was Elizabeth Garrett Anderson. Thanks to Jonathan Reinarz for pointing out that others, such as Elizabeth Blackwell from Bristol, qualified earlier, but did so in America.

Congratulations to David Lissauer, Nathalie Maillard, Alan Hargreaves, Jonathan Reinarz and Vasiliy Vlassov who all answered correctly.
Director's Choice - From the Journals

Psychiatry Comes of Age

In a recent post the CLAHRC WM Director opined that psychiatry was taking its first reductive steps – we are starting to understand the neurochemical mechanisms behind diseases that appear in the mind. Well our toddler has started to run and the new era has been ushered in with a brilliant recent publication in Nature.[1] The story starts, as it increasingly does in modern science, with a large collaborative effort – in this case the international Psychiatric Genomics Consortium, which carries out genetic association studies. Their Biobank harbours 39,000 cases of schizophrenia and 45,000 controls. There are many genetic polymorphisms across the genome that are associated with schizophrenia – about 100 in fact, as mentioned in a previous post. But one constellation of polymorphisms stands out in terms of the strength of its association with schizophrenia. This constellation resides in the HLA gene cluster. Genes in this cluster encode proteins that help the immune system identify foreign antigens, such as those found on the cell surface of microbes or transplanted tissue. Polymorphisms in the HLA cluster are associated with autoimmune disease, meaning that the immune system has mistakenly identified an antigen on a normal host cell for attack. Does this mean that schizophrenia might be an autoimmune disease? Well, sometimes perhaps (see below), but there is another mechanism by which HLA variants may predispose to this devastating disease. It turns out that the part of the HLA complex most closely associated with schizophrenia is the gene responsible for one of the complement proteins known as complement component 4. And this molecule is not just active in eliminating pathogens and cellular debris – it also affects nerve cells by directly accelerating the pruning of synapses. Synaptic pruning is a normal part of adolescent brain remoulding, but excessive pruning, associated with over-active complement 4, features as part of the pathogenesis in many cases of schizophrenia.[1] Enter NIHR CLAHRC East of England Director Peter Jones. Jones hypothesises that around 10% of cases of acute onset schizophrenia result from an acute autoimmune brain syndrome. He is testing this hypothesis by means of a RCT involving immunosuppression. Presumably it is no co-incidence that some cases of schizophrenia result from a form of autoimmune disease, and that genes in the HLA constellation are so frequently associated with schizophrenia. If so, much of the damage may have been done when the acute brain syndrome appears – we may need to look for an earlier, more tightly targeted therapy, and we suspect that preventing complement-mediated damage will play a role. Incidentally, this is a further example of massive scientific achievement emanating from an international collaborative effort, rather than the genius of just one individual. The future prominent scientist will increasingly be the one with the social skills to engineer a prominent place for herself on the committees that shape protocols and scientific papers, such as the Global Burden of Disease project discussed in a recent post.

-- Richard Lilford, CLAHRC WM Director

Return on Investment from Vaccines

CLAHRC Africa has previously carried out health economic assessments in Low- and Middle-Income Countries (LMICs) concerned with devices,[1] [2] and is now doing so with respect to milk banking and breastfeeding in collaboration with the African Population and Health Research Centre (APHRC). We were therefore interested to read a Return on Investment analysis on vaccines in LMICs.[3] Ten vaccines were considered, singly and in combination. The costs of the programmes were obtained largely from Gavi, the Vaccine Alliance. The costs saved were calculated on the basis of costs of treating cases at home (including days off work for carers), costs of admission by hospital day, transport costs to care facilities, costs of care for disabilities, and lost production costs based on discounted per capita GDP for people who died or could not work. Herd immunity was not taken into account, neither were effects on demographic structures of countries, thereby under-estimating return. The return on investment ([monetised benefit – programme cost] / programme cost) was a whopping $16 per dollar expended. There are few other such studies in LMICs, but the return was even higher than deployment of Community Health Workers at $9 per dollar expended, but lower than improving road safety at $19 per dollar expended. The ratios were positive for all the ten vaccine studied, but the most favourable ratio was for measles, followed by yellow fever (a surprise to the CLAHRC WM Director) and Meningococcal meningitis.

-- Richard Lilford, CLAHRC WM Director

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Experimental Study of Income Inequality

Haushofer and colleagues report on a randomised trial of cash transfers to poor people in Kenyan villages.[1] They find that when some people receive a material cash transfer this adversely affects those who do not, on the cognitive, but not affective components of psychological wellbeing. However, the effect is short-lived, dissipating over the 15-month follow-up period in the study. The authors are careful to point out that there is no reason to avoid making the transfers, which, among other things, empower women and reduce violence. In any case, how can society function if people are not allowed to escape from poverty for fear of upsetting their neighbours? All the same, conspicuous consumption is distasteful because it does adversely affect those around you, and should thus be avoided.

-- Richard Lilford, CLAHRC WM Director

 
Comparing Statistical Process Control and Interrupted Time Series

Some people have tried to tell the CLAHRC WM Director that Statistical Process Control (SPC) and standard statistics are completely different ideas – one to do with special cause variation and the other with hypothesis testing. This concept is not so much wrong as it is not right! Fretheim and Tomic recently published a relevant and interesting article in BMJ Quality and Safety.[1] The CLARHC WM Director’s take on this article is as follows. If there is no intervention, then use SPC to detect non-random variation, but if there is an intervention point (or period), use a statistical test. Since such a test uses the information that an intervention has occurred at a certain point in time, it is much more sensitive to change than SPC. Interrupted time series methods should be used to compare the slope of the lines before and after the intervention and remember to allow for any auto-correlation, as emphasised in a previous post. However, the CLAHRC WM Director emphasises  the need for contemporaneous controls whenever possible to allow for temporal trends – ‘rising tide’ situations.[2] He is also very concerned about publication bias arising from selective reporting of ‘positive’ interrupted time series studies. In the meantime, our CLAHRC has discovered that information presented to hospital boards mostly does not use SPC and when it is used, the limits (e.g. two or three SDs) are not stated.[3]

-- Richard Lilford, CLAHRC WM Director

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References
 
More on Publication Bias – This Time in Laboratory Science

Attempts to replicate studies, even those published in Nature, fail to replicate the original results more often than you might think. Well the CLAHRC WM Director was surprised that in some reports, nearly half of original studies could not be replicated. Yet it is hard to publish these iconoclastic studies. So a past editor of Science, along with others, have started a new online journal to mitigate this problem – “Preclinical Reproducibility and Robustness”. They aim “to help improve the self-correcting nature of science to benefit society as a whole, including those of us trying to create new medicines.”[1]

-- Richard Lilford, CLAHRC WM Director

PPI

PPI Opportunity

The NIHR Trainees Coordinating Centre are looking to recruit eight lay members to join the NIHR Clinician Scientist (CS) and Integrated Clinical Academic (ICA) Programme review panels as advisors on PPI. For more information, please click hereClosing date for applications is Wednesday 16 March 2016.

Workshop Summary

Setting Up Research in the NHS: Practical and Ethical Considerations

On 25 February CLAHRC West Midlands hosted a workshop for postgraduates, early career researchers, and research-active and interested individuals in our partner organisations, to explore the practical and ethical considerations for setting up research studies in the NHS. 

Janet Boothroyd from the Health Research Authority (HRA) joined us for the morning session, together with talks from the NIHR CRN and local UHBFT R&D office (Mobeena Naz and Joanne McCormack, respectively). The HRA covered the new research approvals processes, which will replace CSP from March 2016. The HRA will cover the approval process for all health and social care research. This would include public health research with Local Authorities, although studies involving public health staff (e.g. interviews with staff) may not require HRA approval. The CRN talked about portfolio adoption and training support available to researchers in the West Midlands. We do have a number of CLAHRC-affiliated/adopted studies that are also eligible for portfolio adoption, where the main funding for the study is from another NIHR grant. We heard about the local R&D approvals process, where in this example, the Queen Elizabeth Hospital would be a study site for the research project. This highlighted the need for ensuring protocols are externally peer reviewed, which is something the CLAHRC WM organises for researchers for CLAHRC-hosted studies.

In the afternoon, we looked more closely at the ethical considerations, with a stimulating talk from Heather Draper, Professor of Biomedical Ethics at the University of Birmingham, exploring the information provided to participants in order to help them make a decision to join a study (also called the ‘informed consent process’). Previous work conducted by a multi-disciplinary team, including the Professor, showed that a large proportion of people took an active step to engage with a research study after only receiving very minimal information on the study (e.g. study title and aim) and that most participants depend on the information provided at the consent interview to make an informed decision.[1] This led to a very interesting discussion and debate about the 'most appropriate' way to consent patients to studies. Should this be through a Patient Information Sheet (PIS), or should this be through the consent interview and, if so, shouldn't the Research Ethics Committee (REC) consider the contents of the consent interview as well as the PIS, and what about other methods of communication and engagement e.g. videos/social media? We are hoping to make advances in the latter as we pursue a programme of work around ‘public engagement in science’ with the appointment of a Patient and Public Involvement and Engagement Lead.

Finally, we heard from Rev Dr Barry Clark, Alternate Vice-Chair of West Midlands REC South Birmingham, who presented a real-life scenario for the group to consider as if they were a committee member at a REC meeting. The study proposed a trial to evaluate the effects of adrenaline on survival and recovery of survivors at 3, 6 and 12 months after cardiac arrest to establish how safe and effective adrenaline is as a treatment for patients who suffer out of hospital cardiac arrest. This led to an interesting and frank discussion about the people who would fall, at random, in the intervention arm (who would receive the adrenaline) and those in the placebo arm (who would not receive the adrenaline) – potentially ‘an ethical dilemma’. How would you feel if a family member died as a result of not receiving adrenaline and you had no idea that they had been entered into a research study? Although, it is worth noting that current evidence suggest that more people are ‘harmed’ by receiving adrenaline (which is current practice, by the way), than those who don’t. The group were split about whether the study should be approved. If you are interested in the outcome, the trial received approval and is funded by the NIHR (PARAMEDIC 2 trial), led by West Midlands Ambulance Service NHS Foundation Trust – for more information click here. The session was an eye-opener and even inspired some people in the group to join a REC as a volunteer.

Thank you to all those who attended, we hope you found it informative and enjoyable. We urge you to complete the evaluation form so we can collate formal feedback.

If you would like to view the slides from the workshop, they can be found at our slide share account. If you would like a copy of the REC case study used by Rev Dr Barry Clark, please get in contact with Nathalie (n.maillard@warwick.ac.uk) and she will send it to you.

Further information and materials:

-- Nathalie Maillard, Head of Programme Delivery CLAHRC WM
News

Improving Care of People with Long-Term Conditions in Primary Care

Osteoarthritis (OA) and anxiety/depression often coexist with other long-term conditions (LTCs), yet are frequently under-recognised and under-treated, which can lead to poorer quality of life and clinical outcomes, and increased healthcare costs. Primary care is increasingly seen as the optimal setting to deliver care for long-term conditions; however, clinical guidance for managing long-term conditions typically focuses on single disease management.  

Researchers from  NIHR CLAHRC West Midlands  are undertaking the ENHANCE study to test the feasibility and acceptability of a practice nurse-led ‘ENHANCE LTC’ review consultation for identifying, assessing and managing OA-related joint pain and anxiety/depression.  

The ENHANCE LTC review has been co-designed by researchers, patients, clinicians and other stakeholders and involves case-finding for anxiety, depression and OA-related joint pain; development of a management plan, comprising self-management and signposting/referral to other services; and a specially-designed ENHANCE EMIS template. The study will report on both process and research outcomes enabling the acceptability and feasibility of the practice nurse training, fidelity of delivery, and suitability for a larger randomized controlled trial to be fully assessed. For more information please visit www.clahrc-wm.nihr.ac.uk.  

Reproduced from the NIHR CLAHRC Community e-Newsletter


Tom Marshall's Inaugural Lecture

Many of the CLAHRC West Midlands team, together with his colleagues at the University of Birmingham, family and friends, joined Professor Tom Marshall, Professor of Public Health and Primary care, for his inaugural lecture on Wed 3 March at UoB. Tom took the audience through his scientific journey with an enthusiastic talk entitled 'The Knowable and the Unknowable: Reflections on Health Services Research'. He noted a fundamental contrast between clinical practice and its desire to give patients certainty in diagnosis, prognosis and treatment decisions, and the necessity of doubt to drive scientific inquiry. His research journey encompassed patient's treatment preferences, the economics of heart disease prevention, and the challenge of understanding variation. The lecture was punctuated with pictures taken from the London Marathon, which Tom has completed twice, with his best time as 03:05:33 - an impressive average pace of 07:07 minutes per mile(!) Congratulations to Tom on all fronts.


STarT Back Newsletter

The latest STarT Back newsletter has recently been published and provides an update on the progress/rollout of the STarT Back tool - a CLAHRC WM supported project from Keele University. Please click here to view.


Salaried Studentship Opportunity at Keele University

2x Clinical Research Associates / Fellows RE16/06
Fixed term, 3 years FT or 6 years PTE. Closing date 18 March 2016
http://tinyurl.com/RE16-06


Congratulations on Sporting Achievements

Congratulations to Michelle Brown, W-CAHRD Co-ordinator, who completed the recent Coventry Half-Marathon in 2 hours, 5 minutes, 38 seconds (beating her target by nearly ten minutes), and raised over £300 for cancer research.

Also, congratulations to Richard Lilford, CLAHRC WM Director, and Philippa Lilford, blog reader, who completed the 2016 Cape Town Cycle Tour (109km) in 4 hours, 41 minutes, 35 seconds.

Selected Replies

Re:  Another Study of the Effect of Increasing Specialist Availability
on Hospital Mortality Rates

Richard - another fascinating blog but I think you need a bigger envelope... Assuming the transition to intensivist staffing does not change physician to patient ratios, we need to know about the salaries and on-costs of the physicians replaced by intensivists during the transitions as well as those of the intensivists themselves (according to the 2015 Medscape survey, Critical Care physicians are around the centre of the salary distribution across specialties). It's the incremental cost of intensivists (compared with who they replace) that matters under the above assumption; and it is this cost that needs to be less than $5m (before discounting) per 1,000 admissions.

A US Health Resources & Services Administration report to Congress on the Critical Care workforce reports a mean length of stay in the ICU of around 4 days per patient, so that's around 4,000 patient days for our 1,000 admissions. The report cites the COMPACCS study which suggests each patient requires 45 minutes of intensivist care per day; equivalent to around 3,068 hours or, assuming 6 hours of direct patient care delivered per day by each intensivist, 510 days. Moving to intensivist staffing therefore needs to cost less than $9,800 per day - which would actually buy 10 additional critical care physicians. Someone clinging to their 4% relative reduction in mortality would therefore suggest the move would represent good value for money (again, before discounting).

And if, like me, you found applying a difference in difference result to reduce 12% "by 4% to about 0.5%" (sic; it should have been TO about 11.5% or OF about 0.5%) a little confusing, then please support efforts to help us all understand the difference between absolute and relative risks and percentage changes!

-- Celia Taylor

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 Events

06 April 2016
CAT in a Day
Primary Care Sciences Building, Keele University

Health Professionals working with patients with musculo-skeletal disease are invited to attend a CAT in a day workshop - 'Your Clinical Question Answered in a Day' - at Keele University. The workshop will be focused around exercise and is free to attend, but places are limited. To secure a place, please contact Emily Brayford on e.c.brayford@keele.ac.uk by 31 March 2016.

 
12 May 2016
Building a Strong Global Health Research System: Developing the Role of the Nurse Workforce

Macdonald Burlington Hotel, Birmingham

The NIHR Clinical Research Network are hosting an event for NIHR Clinical Research Nurses where they will consider the importance of a vibrant research delivery service to supporting a strong global health system. The interactive day will include invited speakers who will describe the changing landscape from their perspective and present their understanding of the consequences of changes for the research service delivery practice.


For more information, and to register, please click here.
7 June 2016
Early Intervention in Youth Mental Health is Key to Improving the Lives of Young People
MAC Birmingham

CLAHRC West Midlands Theme 2, Youth Mental Health, are hosting an exciting event on 7th June 2016 at the MAC, Birmingham, regarding the new child and adolescent mental health services in Birmingham. 

The Shout Out for Youth Mental Health event will showcase the latest research in the field of youth mental health, particularly regarding the reconfiguration of the 0-25 mental health service in Birmingham, brought about by evidence produced by CLAHRC WM Theme 2. The varied programme will feature input from service users and young people, live entertainment, guest speaker Rt Hon Norman Lamb, and ample opportunities to network with people passionate about youth mental health.

This is an opportunity to share your views on youth mental health and how services may be improved. Get the latest information about the ongoing transformation of youth mental health services in Birmingham and West Midlands.

For more information and to register for the event, visit https://www.eventbrite.co.uk/e/shout-out-for-youth-mental-health-tickets-21312075993.

 
 
Profile

Dr Celia Taylor

Dr Celia Taylor

I am an Associate Professor in Quantitative Methods at The University of Warwick and have been in my current role for just over one year, following five years as Assessments Lead on the MBChB at The University of Birmingham. I am directly attached to CLAHRC-WM Theme 6, Research Methods, but my role includes providing support on quantitative methods to other themes. This gives me a huge amount of variety in my work, although my personal research focus is on errors and adverse events and human resources for health care.  My current and recently-completed projects include an evaluation of the selection process for GP trainees funded by Health Education England; a cost-effectiveness analysis of a liaison and diversion service within the criminal justice system in England; developing a training intervention that focuses on maternal and child health for Community Health Workers in South Africa; and investigating the emotional support needs of patients with end stage renal disease. I also undertake psychometric analyses of the UK Prescribing Safety Assessment and of the Medical Schools Council Assessment Alliance’s ‘Common Content’ items, which are used to compare the passing standard for written finals examinations across UK medical schools. 

Family time is precious, although as my husband has just started his PhD, our son is getting some early exposure to some interesting conversations on study design and statistics. We escape with regular runs (ok, jogs), shared morning doses of Postman Pat, and ‘nee-na’ (mostly fire engines but any emergency vehicle will do) and mini spotting

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Fortnight's Publications

Gajwani R, Parsons H, Birchwood M, Singh SP. Ethnicity and detention: are Black and minority ethnic (BME) groups disproportionately detained under the Mental Health Act 2007? Soc Psychiatry Psychiatr Epidemiol. 2016.

Jones E, Taylor B, MacArthur C, Pritchett R, Cummins C. The effect of early postnatal discharge from hospital for women and infants: a systematic review protocol. Syst Rev. 2016; 5: 24.

Martin J, Taljaard M, Girling A, Hemming K. Systematic review finds major deficiencies in sample size methodology and reporting for stepped-wedge cluster randomised trials. BMJ Open. 2016; 6(2): e10166.

Sidhu M, Daley A, Jolly K. Evaluation of a text supported weight maintenance programme ‘Lighten Up Plus’ following a weight reduction programme: randomised controlled trial. Int J Behav Nutr Phys Act. 2016; 13(1): 19.

Stradling C, Thomas GN, Hemming K, et al. Randomised controlled pilot study to assess the feasibility of a Mediterranean Portfolio dietary intervention for cardiovascular risk reduction in HIV dyslipidaemia: a study protocol. BMJ Open. 2016; 6(2): e010821.

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Tweets

Check out the NIHR Building a research career handbook: http://www.nihr.ac.uk/documents/faculty/Building-a-research-career-handbook.pdf … #NIHRresearch
-- @NIHR Trainees 9 Mar 2016

Today NHS announce 1st #patientsafety investigation unit-our fellows @CarlMacrae & Charles Vincent on why it's vital: http://bit.ly/1M4DXOs 
-- @Health Foundation 8 Mar 2016

great ideas from our steering group today; programme taking shape #youthmentalhealth #earlyintervention
-- @ShoutOutFYMH 2 Mar 2016

I feel duty bound to Tweet this @RoyLilley Faxed to the boardroom http://conta.cc/1SdBsji  via #constantcontact
-- @Stephen Connelly 1 Mar 2016
 

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