New techniques at pilot sites to improve bereavement care for parents

Adobe Spark (1)A new pathway has been launched to improve the quality of care for parents who have lost a baby. The National Bereavement Care Pathway (NBCP) seeks to offer individualised, safe and sensitive care for parents and families at all stages of pregnancy and baby loss up to 12 months.

Led by Sands, the stillbirth and neonatal death charity, it has been produced in collaboration with a core group of charities and professional bodies, comprising the Institute of Health Visiting, the Royal College of Midwives, NHS England, the Royal College of Obstetricians & Gynaecologists, the Royal College of Nurses, Neonatal Nurses Association, Bliss, Antenatal Results & Choices, The Lullaby Trust and Miscarriage Association. It also has the support of the Department of Health and the All-Party Parliamentary Group on Baby Loss.

The first wave of 11 pilot sites has been rolled out across the UK to coincide with Baby Loss Awareness Week and includes Wirral University Teaching Hospital NHS Foundation Trust, Liverpool Women’s NHS Foundation Trust, and Hull and East Yorkshire Hospitals NHS Trust. The sites were chosen to be ‘representative of geography, capacity and specialism’, and will trial the use of new materials, guidelines and training for professionals to help improve the care that bereaved parents receive.

The latest figures show that in 2015 there were over 2,500 infant deaths (that is, deaths under 1 year of age) in England and Wales, with stillbirths and deaths of infants under 7 days accounting for around 6.5 deaths per 1,000 total births (Office for National Statistics, 2017).

Clea Harmer, chair of the NBCP Core Group and CEO of Sands, comments: ‘I am delighted that we have so many enthusiastic partners across the country who want to work with us in improving bereavement care for parents when a baby dies.

‘As a collaboration, we were inundated with offers of support and I am excited by the potential impact that the pathway will have in these 11 sites, in the first instance. We  look forward to learning from their experiences before wave 2 begins and the wider rollout later next year.’

A spokesperson for the Institute of Health Visiting says: ‘The Institute is pleased to be one of the key partners in the project group working to deliver a National Bereavement Care Pathway for England, with the support of the Department of Health and All-Party Parliamentary Group for Baby Loss.

‘We are really keen to support the project group with identification of community health providers [which employ health visitors] that are willing to be included in the second pilot phase. This will ensure that the pathway offers clear, consistent guidance to health visitors and enable them to work confidently alongside parents, providing compassionate and parent-centred care to those affected through use of the pathway.’

Sue Cooper is the bereavement midwife at Hull and East Yorkshire Hospitals NHS Trust. She highlighted the important role that bereavement midwives play in providing support for parents who have lost a child:

‘Losing a child is an incredibly difficult experience and something that no parent should ever have to go through,’ Cooper says. ‘If they do, however, it’s important that we, as health professionals, are able to provide the right advice, information and support for bereaved parents.

‘The quality of care and the empathy shown to parents at a time when they are struggling with a whole range of different emotions is crucial, and our role in guiding bereaved parents through this difficult time is not to be underestimated. How we care for bereaved families when their baby dies can have long-lasting effects. Good care can’t remove parents’ pain and grief, but it can help them through a devastating experience.

Cooper is hoping bereavement care in Hull and East Yorkshire will improve as a result of being one of the pilot sites on the new pathway: ‘We’re really pleased to have been chosen to pilot the new care pathway,’ she says. ‘We’re not only hoping to improve the care we personally provide for bereaved parents, but it will mean a lot to know that what we do here in Hull and East Yorkshire will go on to shape and improve services provided for others right across the country.’

Since the project was initiated, it has engaged with over 200 professionals and 60 parents, completing a gap analysis of current pathways, guidance and research. A number of pregnancy and baby loss pathways have been created, with input from members of the NBCP Parental Advisory Group, which shared their stories to help inform the pathway.

Cathy Warwick, chief executive at the Royal College of Midwives, says: ‘This is important work because it is about giving bereaved families better care following the sad loss of a baby and we need to get it right. Learning from parents and the results of the work at the pilot sites will mean care can be better tailored to meet the needs of families.’

According to Carmel Bagness, Royal College of Nursing’s professional lead for midwifery and women’s health, it is the responsibility of healthcare staff to support bereaved parents: ‘The loss of a baby is an absolute tragedy and it is up to healthcare staff to provide the best care possible for bereaved parents and families,’ she says. ‘This pathway could really help to improve the care they receive during this difficult time. We hope this pilot is just the first step towards better care throughout the country for parents and families suffering from this terrible loss.’

Caroline Lee-Davey, Chief Executive of Bliss, adds: ‘Bliss is proud to be partnering on this project to improve bereavement care for pregnancy and infant loss. We know that being supported in the right way can help grieving parents and families at this heart-breakingly difficult time, and we look forward to working with the pilot sites to deliver consistent, high-quality and parent-centred care.’

A second wave of pilot sites is planned for April 2018, with a national rollout expected later in October.

References

Office for National Statistics. Childhood mortality in England and Wales: 2015. London: ONS; 2017.

Taken from Journal of Health Visiting, published November 2017.

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Not enough ‘safe care’ for maternity service users, warns NHS England

Adobe Spark (8)The chair of the Maternity Transformation Programme in England has warned that not enough is being done to ensure safety within maternity services. Speaking at the NHS England Health and Care Innovation Expo, Professor Sarah-Jane Marsh, said:

‘There are too many families […] who have not had safe care, who we have let down, and we need to do better.

‘Safety has to be at the heart of everything that we do in our maternity services. We have got to get it right. We know how to get it right, [but] often we just don’t do that consistently.’

In Better Births (NHS England, 2016), NHS England emphasised the need for safer, personalised, professional, family-friendly maternity services, realised through Local Maternity Systems, the maternity element of Sustainability and Transformation Plans (STPs). Here, providers, commissioners and organisations work at a local level to oversee and develop health care issues.

While Marsh called the vision ‘clear’, she cautioned that it was not ‘what is being talked about in every maternity unit in the country at the moment.’

Since the Maternity Transformation Programme was launched in July, 44 Local Maternity Systems have been set up to plan the design and delivery of services to populations of 500 000–1 500 000 people. Marsh claimed that these are making headway, and are looking towards the future of maternity services ‘with a ruthless focus on safety and personalisation.’ Although services are becoming safer, she warns that performance, when benchmarked against maternity staff, ‘is not as it should be’.

Marsh also raised concerns that boards are not as focused on maternity services, saying:

‘We need to have people, at board level, who really understand maternity safety, who understand how to get it right as well as to investigate when things go wrong.’

Marsh stressed that, while visions and national programmes are important,

‘The change that really matters is that which is made by clinical teams on the ground, coming together to want to make a difference for the patients, the families, the women they care for. And the women and families themselves having every opportunity to be able to participate, feedback their experience and work with professionals to improve services.’

Marsh also highlighted the importance of multiprofessional working, saying,

‘We need to see ourselves as one big maternity team […] We have got to move away from the idea that maternity care is purely about the midwives and the obstetricians, because there is so much more to it than that. […] Those who work together and train together ultimately go on to do even more personal and safe care.’

This sentiment was also emphasised by Professor Jacqueline Dunkley-Bent, head of maternity, children and young people for NHS England, who said:

‘We are working really hard and we will continue to work hard to ensure that avoidable death is reduced in this country. We have a commitment at the moment on the table from the Department of Health: £8 million has been allocated to support education and training. This fund has been awarded to maternity services to help them develop multidisciplinary training.’

Matthew Tagney, director of the Maternity Transformation Programme, agreed that progress was being made, but warned that the NHS was still far from its target of halving stillbirths, maternal and neonatal deaths, and brain injuries during or soon after birth by 2030:

‘I think there is a tremendous amount happening both nationally and locally.We are on track for 2020 but there is a huge amount more to do.’

While progress is being made on the delivery of better maternity services, there is still a long way to go. This was accepted by Marsh, who apologised to the hundreds of families who had lost babies:

‘You have my commitment and the commitment from the team at NHS England that we will work tirelessly every day to do the things that we know work in patient safety, and to make sure there are no baby deaths in this country that are avoidable.’

References

NHS England. National Maternity Review: Better Births—Improving outcomes of maternity services in England—A Five Year Forward View for maternity care. Leeds, NHS England: 2016

What’s next for England’s ambulance services?

Adobe Spark (7)Details of the delivery of new ambulance standards were outlined by the National Clinical Director for Urgent Care at the Health and Care Innovation Expo in Manchester (NHS England, 2017a). Professor Jonathan Benger provided delegates with an overview of the Ambulance Response Programme, which he called: ‘the way we should do change in the NHS—change that is evidence based from the very beginning.’

Outlining the programme

The implementation of the Ambulance Response Programme was announced by NHS England (2017b) in July, following recommendations by the NHS England National Medical Director, Professor Sir Bruce Keogh, to the Health Secretary (Keogh, 2017). It consists of three initiatives that were developed to try and improve clinical responses for patients.

Phase 1 involved changes to the triage of calls to allow more time for call handlers in cases that are not deemed as immediately life-threatening. This has been referred to as dispatch on disposition. Traditionally, handlers had up to 60 seconds to assess calls and establish the urgency of the problem, and the type of response required. It is at this point that the clock is started for the performance measurement. The subsequent issue was that in an effort to meet an 8-minute response standard, ambulance services were sending multiple vehicles to the same patient and standing down the vehicles they thought wouldn’t get there first. Response cars would frequently be used as a way of ‘stopping the clock’ but then the patient would have a long wait for the transporting ambulance, which was detrimental to the patient but not measured on the system. According to Benger:

‘The problem created was one whereby a paramedic in a response car might spend their entire day just driving from one call to another but never actually reaching a patient.’

The Ambulance Response Programme therefore sought to provide a more clinically appropriate response by targeting the right resource to the right patient. For non-life-threatening calls, ambulance call handlers were given up to an additional 3 minutes to determine what was wrong with the patient and therefore decide an appropriate response.

Phase 2 involved the introduction of a new code set that has four key categories, rather than two, which better reflects the wide range of needs patients have when they dial 999. In the old system almost 50% of calls to ambulance services are classified as Red 1 or Red 2, requiring a response within 8 minutes. However, this does not accurately reflect the type and urgency of care needed by patients (Turner et al, 2017). Under the new system there will now be four revised call categories:

  • Category 1 is for life-threatening calls. These are for people needing treatment for life-threatening illnesses or injuries and will be responded to in an average of 7 minutes
  • Category 2 is for emergency calls. These are potentially serious conditions that may require rapid assessment, urgent on-scene intervention and/or urgent transport. These will be responded to in an average of 18 minutes
  • Category 3 is for urgent calls. These are non-life-threatening problems involving patients needing treatment to relieve suffering. Often they can be managed at the scene and 90% of these patients will be responded to within 120 minutes
  • Category 4 is for less urgent calls. These are for non-urgent problems requiring assessment either face-to-face or by telephone and 90% of these patients will be responded to within 180 minutes.

The final initiative involved a review of the current ambulance system, Ambulance Quality Indicators (AQI), and the development of a revised set of indicators linked to the revised call categories.

Evaluating the programme

A formal trial of Phase 1 began in October 2015 and a trial of the Phase 2 revised call categories began in three services in April 2016. An evaluation of Phases 1 and 2 was published by researchers at Sheffield University (Turner et al, 2017). Benger said:

‘We are very fortunate in the Ambulance Response Programme to have very good stakeholder engagement and excellent independent academic scrutiny from Sheffield University.

‘They have analysed the data we’ve collected from more than 14 million 999 calls. Of those 14 million patients, no patient came to harm as a result of the Ambulance Response Programme.’

The review revealed that under the new dispatch on disposition system, early recognition of life-threatening conditions, such as cardiac arrest, will increase. The knock-on effect is up to an additional 250 lives saved each year. By sending an appropriate response, more vehicles will be freed up to attend emergencies, and patients will be conveyed to the appropriate place.

According to Benger, when call handlers were given more time, rather than impeding or reducing the speed of response for the sickest patients, speed and performance actually improved.

‘The ambulance services became a lot more efficient,’ said Benger. ‘Taking the entirety of both dispatch on disposition and the new coding set together, we were releasing 15 000–16 000 additional resources each week that could respond to a 999 call, when that was not previously the case. And that’s principally from putting an end to duplicate responses.’

Evaluation of Phase 2 on its own, however, is more complicated. The use of time-based standards as a key performance measure have been used by ambulance services throughout the world, despite a lack of evidence that they actually lead to good clinical care. As Phase 2 has only been operational for a short period of time, it is not possible to say whether the new model is better, only that it is ‘different’ (Turner et al, 2017). However, the three services reviewed indicated a period of operational stability during a period of high demand, even when response time performance continued to deteriorate in services operating the current national model.

It is thought that the more flexible approach to call assessment, resource dispatch, and response intervals brought on by the combination of dispatch on disposition and the
new code set, may reduce further deterioration in performance and maintain a consistent service. However, as highlighted by the researchers at Sheffield University, a system of ongoing review and refinement is needed to optimise delivery (Turner et al, 2017).

Implementing the programme

All ambulance services are now using dispatch on disposition, and the new call categories are intended to be fully implemented by winter 2017. This will hopefully reduce pressures on A&Es during their busiest time period.

‘We wanted to make ambulance services as efficient as they could be but that we didn’t lose sight of some of the core aims: prioritising the sickest patients, making sure we incentivise clinically and operationally efficient behaviours, and trying to reduce the long waits for patients,’ said Benger.

‘When I first started in my job, I noticed that when you gathered ambulance chief executives together in a room, they would spend about 90% of the time talking about ambulance response times and 10% about clinical outcomes. I’d like to reverse that.’

As demand for urgent and emergency care sees year-on-year increases, services have to adapt to reduce pressure and ensure patients are able to get the care they need. It is hoped the new ambulance standards will go some way to making this a reality.

References

Keogh B. Ambulance Response Programme—letter to Secretary of State [Internet]. Leeds: NHS England; 2017. Available from http://tinyurl.com/ybfgxmfx

NHS England. What next for England’s ambulance services? Leeds: NHS England; 2017a. Available from http://tinyurl.com/yb7vzk8g

NHS England. New ambulance standards announced. Leeds: NHS England; 2017b. Available from http://tinyurl.com/yc6ywmqs

Turner J, Jacques R, Crum A, Coster J, Stone T, Nicholl J. Ambulance Response Programme: Evaluation of Phase 1 and Phase 2. Final Report. Sheffield: School of Health and Related Research, University of Sheffield; 2017.

Taken from Journal of Paramedic Practice, published October 2017.

Hunt challenges the NHS to deliver digital services by 2018

Adobe Spark (6)The Health Secretary, Jeremy Hunt, has challenged the NHS to deliver digital services nationwide by 2018 to coincide with the NHS’ 70th anniversary next year.

Hunt used September’s Health and Care Innovation Expo in Manchester to highlight the opportunity of technology in creating ‘The patient power decade’. The Health Secretary painted a pixelated portrait of a future shift in power within the NHS from doctor to patient, with the patient ‘Using technology to put themselves in the driving seat of their own healthcare destiny.’

Hunt stated that by the end of 2018, patients will be able to use an integrated smartphone app to access services such as NHS 111, book a GP appointment and even have the ability to view healthcare records online.

Currently, according to NHS Digital, 680,000 patients are viewing their medical records online every month.

In this keynote speech, he further acknowledged how ‘People should be able to access their own medical records 24/7, show their full medical history to anyone they choose and book basic services like GP appointments or repeat prescriptions online.’

Mr Hunt also stated that the app could be used to order repeat prescriptions, access support for managing long-term conditions, or express preferences on organ donation, data sharing, and end-of-life.

Hunt emphasised how the ‘master-servant relationship’ between doctors and patients that has existed for three millennia will be ‘turned on its head’, and patients will use the information that becomes available at their fingertips, ‘to exert real control in a way that will transform the prospects of everyone.’

Overcoming hurdles

If the NHS is to successfully deliver digital health services, there are a number of potential hurdles to overcome. Firstly, there are concerns over the accessibility of services for those unfamiliar with smartphone technology, or from those of disadvantaged backgrounds who cannot afford to buy a smartphone. For this reason, Hunt stressed how the new services will be for everyone:

‘If the NHS is not there for everyone, it is nothing,’ he said. ‘We recognise that not everyone is comfortable using a smartphone. So we will always make sure that when we introduce new services, there is a face-to-face or telephone alternative, for people who do not use smartphones.’

While many older people struggle with online technology, it is worth pointing out this is not always for want of trying. Hunt outlined how 400 000 people have already been trained to help get them online, and over the next 3 years, a further 20 000 digital inclusion hubs will be rolled out. Additionally, wifi will be introduced across primary care this year and secondary care next year, which is hoped will help support people accessing online resources.

Secondly, in lieu of the NHS cyber attacks earlier this year, Hunt conceded that a lot needs to be done to win back the public’s trust:

‘We have to recognise that we still have a lot to do to earn the public’s trust that their patient data is safe with us,’ he said.

As part of this, the Government announced its response to the National Data Guardian and Care Quality Commission report on data security in July. Among the initiatives are 10 new data security standards, a £21 million investment to protect trauma centres from cyber attack and new national support for unsupported Microsoft systems that were part of the original problem that caused the cyber attacks.

The role of mobile technology in delivering health services was also highlighted in a keynote speech from Professor Sir Bruce Keogh, medical director of the NHS. He said we run our social lives, financial lives, travel lives and retail lives online, so why not our health? Keogh welcomed the idea of being able to book GP appointments, get blood results or see X-rays online. However, he also recognised that it brings with it some challenges.

The first challenge is digital therapy, particularly in the area of mental health. According to Keogh, this will involve activities patients can do on their mobile phone that will improve their health, such as talking therapies, so that they do not have to visit a psychologist, psychiatrist or your GP. The NHS will have to work out how it assesses these, but importantly it needs to work out the payment mechanisms behind them so that they are available for everyone on the NHS.

The second challenge concerns what happens when people can get advice and treatment outside normal geographical boundaries. Currently, the way the NHS is structured means a GP is determined by where a patient lives. However, Keogh highlighted how already many are visiting GPs outside the area where they live. He therefore questioned what happens as more people start to access health care not just beyond their local area but beyond their regional area and possibly internationally. He stressed the need to work out who pays for what, the duties of Government and arm’s length bodies with respect to ensuring the safety of those transactions, and the legal implications. The issue is how this can be made part of the NHS, rather than creating a two-tier ‘pay for it if you can’ service.

Looking to the future

Pilot schemes are already underway, with ongoing evaluation before the digital service is introduced nationally. According to Hunt, initial results from pilots in north London, Leeds, London and Suffolk, show that when NHS 111 services are transferred online it is safe. He also pointed out that if digital health services are introduced in the right way, it will save the NHS money. He said: ‘The 6% of people who use the 111 app, rather than speaking to the call handler, save the NHS money. That’s more resources for doctors and nurse.’

Looking to the future, Hunt confirmed that the Government are trying to build the safest, highest quality health system in the world. The role of technology, therefore, is one that he believes is of the utmost importance in making this a reality:

‘As we grapple with the challenges of resources, challenges to improve patient safety, challenges to improve quality and challenges to improve changing consumer expectation, technology can be our friend if we recognise it as a means to an end and not an end in itself, and that end is safer, healthier patients,’ he said.

Taken from British Journal of Healthcare Management, published October 2017.

Experts call on NICE to review TAVI guidelines for aortic stenosis

Adobe Spark (5)Leading experts have urged the National Institute for Health and Care Excellence (NICE) to review its guidelines on the use of transcatheter aortic valve implantation (TAVI) for aortic stenosis to include intermediate-risk patients.

Speaking at a plenary session of the PCR–London Valves conference, experts delivered a focused summary of the new European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) guidelines on valvular heart disease (Baumgartner et al, 2017). This included details of how the guidelines have been updated to lower the threshold for intervention with TAVI to patients at intermediate-risk of surgery. Previous guidance stipulated that TAVI should only be considered for those patients with symptomatic aortic stenosis at high risk of surgery (Vahanian et al, 2017).

Dr Helmut Baumgartner, chair of the taskforce for the European Guidelines, has said the new recommendations mark a profound change to the 2012 guidelines. This is largely owing to the number of randomised controlled trials comparing surgical and transcatheter treatments in the last 5 years. These have looked at intermediate- and low-risk patients treat-ed, not just elderly high-risk patients (Leon et al, 2016). He said:

‘There is much controversy right now over who should undergo surgery and who should undergo per-cutaneous valve implantation, and this is an area in which we have profound changes in what we recommend and have consequently dedicated a large part of the guide-lines to the choice of intervention in symptomatic aortic stenosis.

‘We are now recommending that surgical valve replacement remains the first line of therapy in low-risk patients, and low risk should not only be defined by risk scores, because these have several limitations, but by the lack of frailty and other specific risks for surgery not included in risk scores such as porcelain aorta or sequelae of chest radiation. There are numerous issues that need to be considered before we speak of low-risk patients.’

How NICE guidelines differ

An updated version of NICE’s Interventional Procedures Guidelines (IPG), which considers whether procedures are safe and work well enough for wider use in the NHS, was published a month before the ESC/EACTS guidelines (NICE, 2017). At first glance, it appears not to have revised the indication for TAVI beyond the high-risk patient population, unlike the European guidelines. According to a press advisory from Edwards Lifesciences (2017), NICE said additional trials are needed before TAVI could be considered in patients at inter-mediate risk for surgery:

‘Based on current data, TAVI is recommended in patients with severe symptomatic aortic stenosis who are, according to the heart team considered unsuitable for conventional surgery because of severe comorbidities.

Should NICE guidelines change?

Approximately 1.5 million people in the UK over 65 years suffer from heart valve disease with aortic stenosis (d’Arcy et al, 2016). This represents 2–7% of those over 65 years (Spaccarotella et al, 2011) and 13% of those over 75 years (Nkomo et al, 2006). For many cardiologists, it is believed that expanding the use of TAVI would enable more patients in the UK to have access to the minimally-invasive therapy, rather than have to undergo open-heart surgery.

According to Dr Bernard Prendergast, Consultant Cardiologist at Guy’s and St Thomas Hospital and Course Director/Board Member of PCR London Valves, recent evidence increasingly supports the use of TAVI for intermediate-risk patients. Speaking at the PCR–London Valves conference, he said:

‘There is growing evidence in favour of the use of TAVI for the treatment of intermediate-risk patients with severe symptomatic aortic stenosis. This expanded indication in the ESC/EACTS guidelines paves the way for more patients to receive a true alter-native to open-heart surgery.’

As a result, Prendergast emphasised why NICE should update their guidelines to be in line with the rest of Europe:

‘We are calling for NICE to review their recent IPG in light of these new ESC guidelines in order to address current inequalities in treatment across the UK, and between the UK and most of Europe.’

There is concern that the NICE guidelines leave UK patients at a disadvantage in the treatment of aortic stenosis com-pared with the rest of Europe. Currently, the UK performs far fewer aortic valve implantations than Germany, France, Norway and Sweden.

Clearing up misconceptions

It was hoped in light of the new ESC/EACTS guidelines that this disadvantage would change. However, when NICE was asked if they will be looking into revising their guidelines to recommend TAVI for aortic stenosis for intermediate-risk patients for the writing of this article, they clarified that their guidelines have actually already been extended beyond the high-risk population.

In response to the expert calls for revision and the critical comments quoted in this article, a spokesperson from NICE requested a correction, stating:

‘The new guidance gives standard arrangements for TAVI and does not any longer differentiate between different risk groups. The decision as to which patients are suitable is left to risk assessment by clinicians and the MDT [multidisciplinary team].’

References

Baumgartner H, Falk V, Bax JJ et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38(36):2739–2791.

d’Arcy JL, Coffey S, Loudon MA et al. Large-scale community echocardiographic screening reveals a major burden of undiagnosed valvular heart disease in older people: The OxVALVE Population Cohort Study. Eur Heart J. 2016;37(47):3515-3522.

Edwards Lifesciences Ltd. Leading Experts Call for Adoption of New ESC/EACTS Guidelines on the Management of Valvular Heart Disease to include Intermediate-Risk Patients in National Protocols [Press Advisory]. Berkshire: Edwards Lifesciences Ltd.

Leon MB, Smith CR, Mack MJ et al. Transcatheter or surgical aortic-valve replacement in intermediate risk patients. N Engl J Med. 2016;374(17):1609-20.

National Institute for Health and Care Excellence. Transcatheter aortic valve implantation for aortic stenosis. Interventional procedures guidance [IPG586]. London: NICE; 2017.

Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart disease: a population-based study. Lancet. 2006;368:1005-11.

Spaccarotella C, Mongiardo A, Indolfi C. Pathophysiology of aortic stenosis and approach to treatment with percutaneous valve implantation. Circ J. 2011;75(1):11-19.

Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012;33(19):2451-96.

Taken from British Journal of Cardiac Nursing, published October 2017.

‘Jury is still out’ on success of GP Forward View admits NHS England

Adobe Spark (3)The Director of Primary Care for NHS England, has admitted ‘the jury is still out’ on whether the GP Forward View is working. Speaking at the Health and Care Innovations Expo in Manchester, Dr Arvind Madan outlined progress on the 5-year strategy that aims to stabilise general practice and transform it for the future.

The plan, launched in April 2016, has pledged to increase funding in general practice by £2.4 billion per year and introduce 5,000 extra GPs by 2021. Additionally it seeks to reduce pressure on GPs through a new practice resilience programme.

‘We are in our teenage years and this is where we find out what the character of the programme can ultimately be,’ said Madan. He highlighted early indications suggesting a 5% increase in the number of GPs in training since last year and that they were half way through the 5000 target of other professionals working in primary care.

Madan also highlighted the role of nurses in delivering the GP Forward View: ‘Nursing teams are a vital component of the general practice workforce,’ he said. ‘They provide care and treatment across the life course and increasingly work in partnership with GPs to manage overall demand in practices and treat patients with complex conditions.’

Speaking to Independent Nurse, Dr Crystal Oldman, Chief Executive of the Queen’s Nursing Institute, said there has been some progress following the implementation of the GP Forward Practice View, particularly the introduction of the 10-point action plan to develop the role of general practice nurses.

However, she felt less positive about increases in the numbers of nurses, which she said are ‘not even close’ to what is needed. Additionally, she said she is ‘confident’ there has been no change in the reduction of workload pressures for nurses. According to Oldman, the gap is in the engagement with the nurses themselves:

‘Because they work for individual businesses they are not engaged with the wider movement of general practice nursing,’ she said.

‘I think there is increased hope, and this may mean nurses will stick around in general practices in the hope that this plan is going to make a difference to workforce pressures general practice.’

The importance of nurses to meeting the demands faced by general practice was also emphasised at the same event by Professor Jane Cummings, Chief Nursing Officer for England, who described practice nurses as ‘central to our plan to ensure the NHS is fit for the future’.

Taken from Independent Nurse, published 15 September 2017.

Adverse effects of slimming drug orlistat were underreported

Adobe Spark (5)A new study comparing the protocols, clinical study reports (CSRs) and published papers on anti-obesity drug orlistat, has revealed a disparity in how adverse events were summarised and reported (Schroll et al, 2016).

Orlistat, which is manufactured by pharmaceutical company Roche, was approved by the European Medicines Agency (EMA) in 1998 but, along with other slimming drugs, has since encountered regulatory barriers. Nearly all slimming pills (but not orlistat) have been withdrawn from European markets because of harms.

Researchers at the Nordic Cochrane Centre in Copenhagen used a Freedom of Information Act request to the EMA to acquire the CSRs, which describe the results of studies conducted as part of the application for marketing authorisation of the drug.

Seven randomised placebo controlled orlistat trials were included in the application for marketing authorisation for the drug, and involved a total of 4,225 participants. Adverse events outlined in the CSRs were then compared by the researchers to each corresponding published trial paper identified on PubMed.

It was revealed that due to post hoc filters, only 3–33% of the total number of investigator-reported adverse events from the trials were outlined in the publications, though six of seven papers stated that ‘all adverse events were recorded.’

The investigators noted that none of the protocols to investigators for reporting harms or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were ‘bothersome,’ a condition that was not specified in the protocol for two of the trials. Events falling under the bracket of bothersome included ‘fatty/oily stool,’ ‘liquid stools’ (which term the protocol suggested to be used instead of diarrhoea), ‘increased defaecation,’ ‘stools soft,’ ‘decreased defaecation,’ and ‘pellets.’ Results sections in the core reports of the CSRs often stated that most of the adverse events were considered unrelated to the drug and that they were generally mild to moderate. The many gastrointestinal adverse events were explained as part of the pharmacological effect of orlistat. The researchers suggested that since gastrointestinal complaints are normal in healthy people, this type of censoring might have made it more difficult to detect gastrointestinal adverse events caused by orlistat.

Additionally, serious adverse events were assessed by the researchers for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group.

The researchers also revealed that in one trial, both the number of adverse effects and the number of days with adverse effects in participants taking the drug were understated in the corresponding publication. While 1,318 adverse events were not listed or mentioned in the CSR itself, the researchers were able to identify them through manually counting individual adverse events reported in an appendix.

Overall, the analysis revealed that participants treated with orlistat had experienced almost twice as many days with adverse events as those treated with placebo (22.7 days versus 14.9 days). Additionally, it was noted that the adverse events that occurred in the orlistat group were more severe compared with the placebo group. However, none of this information was stated in the CSR or the corresponding published paper.

A statement issued by Roche said: ‘Since the 1990s, technology for analysing data has changed and society’s desire and expectations for access has increased and so our practices have evolved.

‘We understand and support calls for the pharmaceutical industry to be transparent about clinical trial results, this is why we expanded our policy in 2013 to better share data from clinical trials across Roche medicines.

‘Roche are now at the forefront of the data sharing movement and now release all clinical study reports, periodic safety reports and summary reports of clinical data for all licensed, terminated or discontinued medicines.’

Based on the characteristics of harms observed and reported in these trials, the researchers at the Nordic Cochrane Centre suggested that reports of harms include duration of adverse effects. They also suggested that systematic reviews of drugs might be improved by including protocols and CSRs in addition to published articles.

They highlight how even though publication bias is well covered in the medical literature, few studies have analysed clinical study reports. They argue that in the future this could be a very important source of information. Other studies have found that only a fraction of adverse events were reported in published papers compared to the CSRs. For example, a study carried out by the German government’s Institute for Quality and Efficiency in Health Care looked at the CSRs for treatments assessed over a 5-year period and found that CSRs contained more information on adverse events and treatment effects than was published in trial reports and journal articles (Wieseler et al, 2013).

As mentioned by Schroll et al (2016), their research emphasises the ‘need for detailed analysis plans for harms data.’

References:

Schroll JB, Penninga EI, Gøtzsche PC (2016) Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis. PLoS Med 13(8): e1002101. doi: 10.1371/journal.pmed.1002101

Wieseler B, Wolfram N, McGauran N et al (2013) Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data. PLoS Med 10(10): e1001526. doi: 10.1371/journal.pmed.1001526

Taken from Nurse Prescribing, published 13 October 2016.