Flu vaccination guidance updated for older patients

My Post (13)Public Health England (PHE) has updated its national immunisation guidance following evidence that adjuvanted trivalent influenza vaccines (aTIVs) work better for older patients than other flu jabs (PHE, 2017a).

The Green Book (PHE, 2017a), which features the latest information on vaccines and vaccination procedures in the UK, has been amended after the Joint Committee on Vaccination and Immunisation (JCVI) recommended aTIV, FLUAD®, for the 2018–19 flu season in its October meeting.

The Committee agreed that use of aTIVs in those aged 65 years and over is ‘more effective’ than current nonadjuvanted vaccines and ‘highly costeffective’ (JCVI, 2017).

Dr George Kassianos, national immunisation clinical lead for the Royal College of General Practitioners, said:

‘I very much welcome this guidance by the JCVI. Year on year, it is becoming more and more evident that conventional non-adjuvanted influenza vaccines do not provide sufficient protection for our older patients, particularly in years dominated by the influenza A(H3N2) virus, which dominated the flu season last year and the year before. Use of this adjuvanted vaccine is expected to result in fewer infections, fewer GP consultations and hospital admissions, and a significantly reduced winter burden on the NHS.

‘On the basis of the recent JCVI Meeting minutes outlining the clinical and cost-effectiveness evidence in elderly patients, GP practices are now able to seriously consider the adjuvanted flu vaccine for their patients aged 65 years and over for the 2018–19 flu season.’

Sharon Graham, senior lecturer in nursing at Staffordshire University and a former practice nurse, said:

‘In primary care we need to ensure that we can offer the most effective prevention against influenza to our patients aged over 65 years. This JCVI guidance will, I hope, help vaccinating health professionals to make the best choice of flu vaccine for next year’s season.’

Reasons behind the decision

Last year, PHE (2017b) declared conventional non-adjuvanted influenza vaccines provided little or no protection for over 65s in the 2016–17 flu season in the UK. This was recognised by the JCVI, who acknowledged ‘low influenza effectiveness’ in those aged 65–74 years throughout seasons affected by the A(H3N2) flu strain, and ‘non-significant vaccine effectiveness’ for all types of influenza in the over 75s (JCVI, 2017).

By comparison, the JCVI said aTIVs have ‘better immunogenicity and effectiveness’ in the elderly. While vaccine effectiveness decreases with increasing age and immunosenescence, a study from British Columbia used multivariate analysis to show vaccine effectiveness of around 60% in the elderly for aTIVs (Van Buynder et al, 2013). Almost half of the patients enrolled were aged over 85 years. Conversely, non-adjuvanted trivalent influenza vaccine was deemed ineffective. This is not uncommon, ineffectiveness of non-adjuvanted trivalent influenza vaccines in this patient population has been previously reported (Treanor et al, 2012).

A systematic review and meta-analysis of trivalent inactivated vaccine adjuvanted with MF59 found it was effective in reducing several influenza-related outcomes among the elderly, especially hospitalisations due to influenza-related complications (Domnich et al, 2017). It was also reported to be superior to non-adjuvanted vaccines.

Evidence presented at the European Scientific Working group on Influenza (ESWI) meeting in Riga, Latvia last September, revealed 1700 flu-related deaths could be prevented in those aged over 65 years who switched to an aTIV (Nguyen et al, 2017). Additionally, estimations by the researchers show as many as 195 600 cases of flu could be avoided. According to the researchers, this could reduce the number of GP visits by 21,800.

Research consultant and lead author of the study, Dr Van Hung Nguyen, said:

‘The model demonstrated that the adjuvanted vaccine had an incremental cost-effectiveness ratio of £3540 per quality-adjusted life year if used preferentially in those aged 65 years of age and over in the UK.

‘This is well within, and actually considerably below, the National Institute of Health and Clinical [sic] Excellence’s guideline threshold of £20 000 per quality-adjusted life year for medicines.’

Dr Marco Barbieri, from the Centre for Health Economics at the University of York, said:

‘Health economic analyses consistently show that more effective flu vaccines are very good value in older patients.

‘They reduce the number of GP consultations, A&E visits and episodes of serious illness and, of course, they help older people to remain healthy and independent.’ Commenting on the research presented at the ESWI, he said: ‘These data suggest that use of an adjuvanted influenza vaccine is a cost-effective option for the NHS immunisation programme.’

Mathematical modelling by PHE indicates the adjuvanted vaccine would be highly cost-effective in both the 65–74 and 75 year and over age groups, even under conservative estimates (PHE, 2017a).

Marketing authorisation of FLUAD®

The aTIV FLUAD® gained marketing authorisation in the UK in August 2017. It has been licensed in some countries in Europe since 1997 and in the US since 2015. According to its manufacturer, Seqirus, aTIV has superior seroconversion rates (the time period during which a specific antibody develops and becomes detectable in the blood) in the elderly, and superior geometric mean titres (the central number in a geometric progression of the concentration of a solution as determined by titration) in clinical risk groups against all three influenza vaccine types, compared to non-adjuvanted inactivated influenza vaccines.

Dr Russell Basser MD, chief medical officer of Seqirus, said:

‘We understand the devastating human impact of influenza infection in adults aged 65 years and older, the substantial societal impact of influenza, as well as the cost to the NHS in preventable GP appointments and preventable hospitalisations.

‘We believe that our strong and robust data on FLUAD®’s clinical efficacy, real-world effectiveness, and well-established safety profile, built up over 20 years of use, demonstrates convincingly that this adjuvanted influenza vaccine has clear advantages for adults aged 65 years and over when compared to existing conventional non-adjuvanted vaccines. We consider that FLUAD® can make a major contribution in reducing the burden of influenza on the health services, locally, regionally, and nationally.’

The company has recently announced a major investment in its Liverpool influenza vaccine manufacturing plant. This will allow-end-to-end manufacture of vaccines at the UK site, meeting growing demand and strengthening reliability of supply of FLUAD® for UK and global markets.

References

Domnich A, Arata L, Amicizia D, et al. 2017. Effectiveness of MF59-adjuvanted seasonal influenza vaccine in the elderly: A systematic review and meta-analysis. Vaccine. 35(4):513- 520

Joint Committee on Vaccination and Immunisation. 2017. Draft minute of the meeting on 4th October 2017. London: JCVI

Nguyen VH, Kelly C, Mansi JA. 2017. UK health economic model demonstrates use of adjuvanted trivalent seasonal influenza vaccine in older adults to be highly cost-effective [abstract]. Presented at the Sixth ESWI Influenza Conference, Riga, Latvia, 2017 September 10–13. http://eswi.org/ influenzaconferences/wp-content/uploads/ sites/13/2017/09/Nguyen_Kelly_Mansi.pdf (accessed 2 February 2018)

Public Health England. 2017a. Influenza: The Green Book. London: The Stationery Office

Public Health England. 2017b. Influenza vaccine effectiveness (VE) in adults and children in primary care in the United Kingdom (UK): provisional end-of- season results 2016-17. London: The Stationery Office

Treanor JJ, Talbot HK, Ohmit SE, et al. 2012. Effectiveness of seasonal influenza vaccines in the United States during a season with circulation of all three vaccine strains. Clin Infect Dis. 55(7):951-9

Van Buynder PG, Konrad S, Van Buynder JL, et al. 2013. The comparative effectiveness of adjuvanted and unadjuvanted trivalent inactivated influenza vaccine (TIV) in the elderly. Vaccine. 31(51):6122-8

Taken from Nurse Prescribing, published January 2018.

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Key areas of interest for paramedics in 2018

My Post (11)The most substantial development concerning paramedics this year is prescribing. Proposals to introduce independent paramedic prescribing were made to the Commission on Human Medicines (CHM) in 2015. However, the CHM did not support the proposals at that time. The College of Paramedics and NHS England went back to the CHM in July 2017 with case studies and an implementation plan to try and get further discussion. The following December the CHM decided to support independent prescribing by paramedics. It will now recommend implementation by making a submission to government ministers.

There is still a lot of work to be done and this is likely to be the key area for development of the profession in 2018. Legislation changes need to be made to enact the recommendation. Universities will have to develop their prescribing programmes and the Health and Care Professions Council (HCPC) will need to update its Standards for Prescribing. While it is unlikely there will be any paramedic prescribers until 2019 at the earliest, this marks a key progression in the development of the profession.

In September 2017, the HCPC began consulting on the threshold level of qualification for entry to the register for paramedics. The current level is outlined in the HCPC Standards of Education and Training at ‘equivalent to Certificate of Higher Education for paramedics’. However, the Paramedic Evidence Based Education Project (PEEP) report recommended the level to the paramedic register be raised to BSc (Hons) degree by 2019.
The consultation document proposes the level of qualification should be amended, due to the changing nature and complexity of the role of paramedics, and it illustrates the ongoing diversity in current qualifications across the UK. Any resultant change would not affect existing registered paramedics or students who are part way through pre-registration education and training programmes. The consultation closed on 15 December, with the outcome expected early this year.

Clinical practice

The UK Ambulance Services Clinical Practice Guidelines, last published in 2016, published supplementary guidelines last year. Although there will not be a new version of the guidelines this year, ongoing updates continue to be published online.

The National Institute for Health and Care Excellence (NICE) is updating its Quality Standard on Trauma. This quality standard covers assessment and management of trauma (complex fractures, non-complex fractures, major trauma and spinal injury) in adults, young people and children. It does not cover hip fracture or head injury as these topics are covered in a separate Quality Standard. The draft quality standard was open for consultation from 7 November to 5 December. The final Quality Standard is expected to be published on 29 March 2018.

Initial results from the AIRWAYS-2 trial are likely to be seen in spring 2018. This randomised trial is comparing the clinical and cost effectiveness of the i-gel supraglottic airway device with tracheal intubation in the initial airway management of patients suffering an out of hospital cardiac arrest.

At the time of writing, the final publication of the College of Paramedics’ position statement on paramedic intubation is still impending. Work began in May 2017 on the statement, with a group meeting in July to discuss and develop a first draft. This statement was reviewed and amended by several key clinical groups before being released to the membership and wider stakeholder organisations for comment. Consultation ran in September 2017, with final publication imminent.

Service delivery

NHS England and NHS Improvement have called on all A&E Delivery Boards to implement measures to reduce the impact of ambulance handover delays. They have outlined key principles concerning actions to be embedded as part of normal working practice, and actions to be taken should ambulances begin to queue.

Among the principles, they state acute trusts must always accept the handover of patients within 15 minutes of an ambulance arriving at the emergency department; that leaving patients waiting in ambulances or in corridors supervised by ambulance personnel is inappropriate; and that the patient is the responsibility of the emergency department from the moment that the ambulance arrives, regardless of the exact location of the patient. It will be interesting to see if the implementation of these measures will have an impact on reducing ambulance handover delays in 2018.

Ongoing feedback on the roll out of the Ambulance Response Programme (ARP) will continue throughout the year. The ARP saw changes to the triage of calls, known as dispatch on disposition, to allow more time for call handlers in cases that are not deemed as immediately life-threatening. Additionally, new call categories were introduced to better reflect the wide range of needs patients have when they dial 999. It is likely there will be national updates on the effectiveness of the ARP, hopefully with benefits of the change being seen, in 2018.

The NHS was promised £1.6 billion for 2018/19 and £900 million for 2019/20 in the autumn budget. While this is certainly welcome relief, it is still a far cry from the £4 billion health experts said the NHS needed. It is believed £1 billion of the cash pot for 2018/19 will be used to improve performance against the 18-week target for elective treatment and £600 million to help hospitals meet the 4-hour target in A&E.

Conclusions

These are just a few of the elements that will affect paramedics this year. Other areas not mentioned include the Assaults on Emergency Workers (Offences) Bill 2017–19, development of the nursing associate role, the national programme to support allied health professionals to return to practice, and the final report of the Asthma Audit Development Project. There are many challenges facing the NHS in the coming year, but with the upcoming developments in the profession, paramedics will find themselves in a key position to alleviate many of these pressures.

Taken from Journal of Paramedic Practice, published January 2018.

More nurses leaving the profession than joining, figures show

My Post (10)More registered nurses are leaving the profession than joining, analysis by the Nursing and Midwifery Council (NMC) has revealed. First published in July, the data showed that the overall number of leavers has increased from 23 087 in 2012/13 to 34 941 last year (NMC, 2017a). By contrast, the number of initial joiners was 29 025 for 2016/17.

Jackie Smith, NMC Chief Executive and Registrar, said: ‘At a time of increased pressure on the healthcare workforce to deliver quality patient care, we hope our data will provide evidence to support government and employers to look in detail at how they can reverse this trend.’

Recent figures reveal that the number of registered nurses has continued to decline, with 27% more people leaving the register than joining between October 2016 and September 2017 (NMC, 2017b).

‘These alarming new figures represent a double whammy for the NHS and patients,’ said Royal College of Nursing (RCN) Chief Executive Janet Davies.

‘Not only has the number of UK nurses quitting the profession gone up, but significant numbers of EU-trained nurses on whom the health service depends are leaving and there’s been a huge drop in nursing staff coming to work here from EU countries.’

The number of nurses and midwives from Europe leaving the register has increased by 67%, while the number joining the register from the EU has dropped by 89%.

Although the NMC does not have separate figures for the number of practice nurses leaving the profession, records show that in March 2017 there were 15 528 full-time equivalent practice nurses. This represents a decrease of 225 since March 2016 (NHS Digital, 2017). The number of European nurses joining and leaving general practice is unclear.

Why are nurses leaving?

One of the key reasons nurses are leaving the register is because an increasing number are reaching retirement. Nurses of the ‘baby boomer’ generation are now able to claim their NHS pension, and many are choosing to do so. Under the NHS pension scheme, nurses who were working on or before 6 March 1995 have the right to retire at 55 without any reductions in their pension.

‘Nursing and midwifery are widely acknowledged to be ageing professions, with significant numbers on the register coming up to retirement age,’ said Ms Smith.

It is this factor, combined with increasing workloads, that is encouraging nurses to leave the profession early said Crystal Oldman, Chief Executive of the Queen’s Nursing Institute. ‘I think what’s happening is with the increasing demands on individual nurses in their areas of practice, those at that age—between 55 and 65—are saying, “you know what, this is not what I joined to do,”’ she said.

‘“I am not able to give the care that I used to be able to give, so I’m going to retire now. I’m not going to revalidate, I’ll come off the register, I’ll take my pension.”’

Jenny Aston, Royal College of General Practitioners Nurse Champion, agrees that retirement is the main reason for increasing numbers of practice nurses leaving. ‘The QNI survey that was done a few years ago suggests that there are about 30% due to retire in the next 2–3 years,’ she said. ‘That’s going to be a massive number, unless for some reason they wish to stay on or are encouraged to stay on.’

Valerie Ely, 58, is a registered nurse and senior lecturer at Huddersfield University who is in the process of taking voluntary severance. She went part time at 55, because to remain a manager she was required by the university to do a PhD.

‘I am sad about it and to some extent a bit bitter, but I am 58 so have to accept it,’ she said. ‘A PhD would be 6 years part time and it’s really performance managed.’

‘The irony of my redundancy date is that it’s the same day I would have had to renew registration and revalidate. I have not been clinical for some years and it’s unlikely I’m going to get a job at another university, so I don’t feel that I have many options to stay on the register,’ she added.

But not all those leaving are of retirement age. Of those who didn’t cite this as their reason for leaving, the average age has reduced from 55 in 2013 to 51 in 2017. Additionally, the numbers of leavers aged 21–30 years has increased from 1 510 in 2012/13 to 2 901 in 2016/17.

A survey of 4 500 nurses and midwives carried out by the NMC revealed that working conditions, a change in personal circumstances, and a disillusionment with the quality of care provided to patients were also cited as reasons for leaving.

Sarah is a lead practice nurse at a GP surgery in South Yorkshire. She has been a practice nurse for 9.5 years but is leaving to take up a respiratory nurse role at a hospital trust. She is hoping the new job will bring back her passion for nursing.

‘As nurses experience tougher work conditions, the importance of ensuring they are valued cannot be understated’.

‘Although I enjoy the variety within the role, I am increasingly feeling overwhelmed with the extent of the knowledge and skills I need to be competent to do my job,’ she said. ‘There are only two nurses at my surgery, so we both need to be able to do everything within the practice nurse remit.’

As nurses experience tougher work conditions, the importance of ensuring they are valued cannot be understated. Kathryn Yates, Professional Lead for Primary, Community and Integrated Care at the RCN, thinks that the feedback from patients, families and carers about the outstanding care they receive from general practice nurses is incredibly important.

‘We need to continue to raise the profile of general practice nurses and how valued they are,’ she said. ‘I think we need more evidence to support that.’

Additionally, Dr Oldman says that, due to increased workloads, many nurses are finding themselves no longer doing the job they were trained to do. This understandably causes frustration and a decrease in job satisfaction. ‘They may not be leaving if the conditions were suitable for them to give the best possible care they want to give,’ she said. ‘We have a lot of anecdotal evidence from nurses who say, “I would stay, but I can’t do the job I was trained to do.”’

This lack of being valued is at the heart of why Sarah decided to leave practice nursing. ‘There is a lack of understanding and awareness of what practice nursing involves, which has an impact on others’ expectations,’ she said. ‘It is viewed by the public and other nurses/health professionals as an easy job, with nice hours and none of the pressures that are obvious in hospitals, emergency departments etc.

Our contribution is usually overlooked or any achievements attributed to GPs.’

Combatting the problem

Central to the issue of recruitment and retention is a workforce plan that ensures there are sufficient numbers of nurses now and in the future. A clear workforce plan also allows for accountability when those numbers aren’t met.

Crystal Oldman said: ‘I think the issue is about having a robust workforce plan and also having accountability for that somewhere centrally. Each individual provider must have its own workforce plan, but we are a national health service. What I would like to see is a national workforce plan for registered nurses.’

Kathryn Yates supports this but adds: ‘If we signpost to one particular organisation, it may devolve responsibility. I think there is also a sense of being mindful of how organisations work together to try and come up with real-time solutions.’

For Jenny Aston focusing on training the next generation and making nursing an attractive career is key. ‘Nursing isn’t going to change over the next 10 years: there are still going to be injections, there is still going to be lots of wound care, there is still going to be a need to monitor patients’ health,’ she said. ‘The work is not going away. There may be bigger practices, but I don’t see the nursing activity changing and, therefore, there is going to be an ongoing need to train up the next generation because 30% are going to be retired in 3 years’ time.’

Additionally, there need to be incentives for nurses not to retire early. ‘What lots of people don’t realise is that there are ways to stay on, claim your pension and make your pension arrangements different, so you don’t lose out on the final salary [pension benefits],’ said Ms Aston. ‘But I don’t think many nurses have good financial advice on how they get the best out of staying in work.’

Most importantly, nurses have to be listened to, so their concerns are understood and they feel valued. According to Kathryn Yates, it may be unclear what their needs are: ‘Going forward we may have a workforce that wants to work differently, and we must continue to make nursing an attractive and first destination career.’ she said.

Maria Caulfield, former nurse and Conservative MP for Lewes, said: ‘While I welcome the fact that more nurses are entering the profession than ever before, I am concerned that we are losing large numbers of our most experienced nurses, who are retiring or leaving the profession early. As a result, overall nursing numbers remain static at a time when the demand and need for nurses are increasing. There are a variety of reasons why nurses are leaving and certainly the pay freeze and cap have not helped morale, but from talking to colleagues it is the lack of overall recognition and feeling of worth that has led to many walking away. This is why I have lobbied ministers to ensure nurses are recognised. Lifting the pay cap is one way to show this.’

Health Education England oversees education and training of NHS staff. It has identified the need for additional supplies of nurses and improved rates of employment for graduates. Closing current shortages will also help with moderating increasing workloads.

NHS Improvement has launched a programme to improve retention of NHS staff by 2020. It will look at reasons why staff are leaving to help understand how to improve retention rates.

References

NHS Digital. General and Personal Medical Services, England March 2017. https://digital.nhs.uk/catalogue/PUB30044 (accessed 13 December 2017)

Nursing and Midwifery Council. The NMC Register: 2012/13–2016/17. 2017a. https://www.nmc.org.uk/globalassets/sitedocuments/other-publications/nmc-register-2013-2017.pdf (accessed 13 December 2017)

Nursing and Midwifery Council. The NMC Register: 30 September 2017. 2017b. https://www.nmc.org.uk/globalassets/sitedocuments/other-publications/the-nmc-register-30-september-2017.pdf (accessed 13 December 2017)

British Thoracic Society/Scottish Intercollegiate Guidelines Network. SIGN 153. British guideline on the management of asthma 2016. 2016. https://www.brit-thoracic.org.uk/document-library/clinical-information/asthma/btssign-asthma-guideline-2016/ (accessed 19 December 2017)

National Institute for Health and Care Excellence. Asthma: diagnosis, monitoring and chronic asthma management. 2017. https://www.nice.org.uk/guidance/ng80 (accessed 19 December 2017)

Taken from Practice Nursing, published January 2018.

The use of anti-inflammatory canakinumab could reduce risk of heart attack

My Post (9)Results from a recent trial of the anti-inflammatory drug canakinumab have revealed it could help reduce risk of heart attack and mark the biggest breakthrough in cardiovascular treatment since statins.

The Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS) looked at people who previously suffered from a heart attack and tested whether administration of canakinumab  could reduce inflammation and reduce risk of future cardiovascular events (Ridker et al. 2017).

Speaking at the European Society of Cardiology Congress in Barcelona, where the findings were presented, Professor Paul Ridker of Harvard Medical School, said:

‘These findings represent the end game of more than two decades of research, stemming from a critical observation: half of heart attacks occur in people who do not have high cholesterol. For the first time, we’ve been able to definitively show that lowering inflammation independent of cholesterol reduces cardiovascular risk.’

According to Ridker this has far-reaching implications:

‘It tells us that by leveraging an entirely new way to treat patients—targeting inflammation—we may be able to significantly improve outcomes for certain very high-risk populations, he said.’

Outlining the trial

The trial was conducted by researchers from a wide range of international organisations, including the Center for Cardiovascular Disease Prevention and the Cardiovascular Division at Brigham and Women’s Hospital, Harvard Medical School, Boston; Novartis in East Hanover, NJ, and Basel, Switzerland; the Federal University of São Paulo; Universitätsmedizin Berlin; and the Academic Medical Center of the University of Amsterdam.

Participating centres in 39 countries enrolled patients who had a history of heart attack and an elevated blood level of high-sensitivity C-reactive protein. It is believed raised levels of this protein may lead to further heart attacks.

Participants received doses of 50 mg, 150 mg or 300 mg of either canakinumab or placebo. These were administered subcutaneously every 3 months. Patients were excluded from the study if they had any of the following:

  • History of chronic or recurrent infection
  • Previous cancer other than basal-cell skin carcinoma
  • Suspected or known immunocompromised state
  • History or high risk of tuberculosis or disease related to the human immunodeficiency virus
  • Ongoing use of other systemic anti-inflammatory treatments.

The 10,016 participants recruited to the study were then monitored over the next 4 years. The researchers predominantly wanted to see whether participants suffered from additional heart attacks or stroke, or died from cardiovascular disease during this time.

In total, 1,490 participants experienced the main combined outcome of heart attack, stroke, or death from cardiovascular disease within the 4 years monitored. Within the placebo group, there was an average of 4.5 of these main events per year per 100 people. The treatment groups revealed there was no statistically significant difference between the 50 mg group, compared with placebo. The 150 mg group indicated a 15% lower risk compared with placebo (3.86 events per year per 100 people), while the 300 mg group showed a 14% lower risk (3.90 events per year per 100 people). The researchers concluded that 150 mg of canakinumab taken every 3 months led to a significant reduction in recurrent cardiovascular events compared with placebo.

Considering the results

The potential implications for medicine of this study are considerable, with mainstream media hailing it as a remarkable breakthrough (BBC 2017) and calling canakinumab a ‘new wonder drug’ (Donnelly 2017). For a drug traditionally used in the treatment of arthritis it certainly makes for great headlines. However, there are a number of considerations that must be taken into account before the drug is hailed as the medical advancement some have claimed.

Highlighting limitations

As mentioned, the study only looked at patients who have already had heart attacks. This is something many of the media’s headlines failed to convey (NHS Choices 2017). The effect of the drug, therefore, on reducing inflammation in people who have not had a heart attack, remains unknown. Additionally, many newspapers claimed that canakinumab was ‘better than statins’, but this is unhelpful as it does not reflect the nature of the study. It is thought that if canakinumab was licensed as a preventative medication, it is likely it would be given to people who wouldn’t benefit from taking statins (NHS Choices 2017).

Most importantly, before any changes can be made to the current licensing of the drug, further research is needed to confirm both the beneficial effects and the optimal dose. This was highlighted in an editorial by Dr Robert A Harrington of Stanford University published alongside the study (Harrington 2017), who called the clinical benefit of canakinumab ‘modest’. He argues that ‘a better understanding of the risks and benefits of this form of therapy is needed’ and raised concerns about the fatal infections encountered in the trial and sepsis. He also cites concern over the cost of using canakinumab in patients with a previous heart attack.

Cost matters

Canakinumab is currently licensed in the United States to treat systemic-onset juvenile rheumatoid arthritis at a cost of approximately $200,000 per year (Harrington 2017). While this pricing may be suitable for rare diseases, it is unsuitable for common indications such as coronary artery disease. Given the study was funded by Novartis, the manufacturer of the drug, substantial evidence of its benefit is needed before wider licensing of the drug can be considered.

References

BBC News. Anti-inflammatory drug ‘cuts heart attack risk’ [Internet]. London: BBC News; 2017 Aug 28 [cited 2017 Sep 7]. Available from http://www.bbc.co.uk/news/health-41071954

Donnelly L. New wonder drug hailed as biggest breakthrough in fight against heart attacks and cancer [Internet]. London: The Telegraph; 2017 Aug 27 [cited 2017 Sep 7]. Available from http://www.telegraph.co.uk/science/2017/08/27/new-wonder-drug-hailed-biggest-breakthrough-fight-against-heart/

Harrington RA. Targeting inflammation in coronary artery disease. N Eng J Med [Internet]. 2017 Aug 27 [cited 2017 Sep 6]. Available from http://www.nejm.org/doi/full/10.1056/NEJMe1709904

Ridker PM, Everett BM, Thuren T et al. Antiinflammatory therapy with canakinumab for atherosclerotic disease. N Engl J Med [Internet]. 2017 Aug 27 [cited 2017 Sep 6]. Available from http://www.nejm.org/doi/full/10.1056/NEJMoa1707914?query=featured_home&#t=articleTop

NHS Choices. Anti-inflammatory drug may help prevent heart attacks [Internet]. 2017 Aug 30 [cited 2017 Sep 6]. Available from http://www.nhs.uk/news/2017/08August/Pages/Anti-inflammatory-drug-may-help-prevent-heart-attacks.aspx

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

First ESC Focused Update on dual antiplatelet therapy in CHD

My Post (8)The European Society of Cardiology (ESC) has published its first Focused Update on the use of dual antiplatelet therapy (DAPT) in coronary heart disease (CHD) (Valgimigli et al, 2017). Produced in collaboration with the European Society for Cardio-Thoracic Surgery (EACTS), the document addresses recommendations on a medical treatment that has seen conflicting advice over the years.

Conflicting evidence

According to Dr Marco Valgimigli, Chairperson of the ESC/EACTS Task Force, the conflicting evidence surrounding DAPT has resulted in many people calling it a controversial topic:

‘This has led to a great deal of uncertainty in the medical community, particularly regarding the optimal duration of DAPT after coronary stenting,’ he said.

A survey initiated by the European Association of Percutaneous Cardiovascular Interventions sought opinions from the medical community on the evidence relating to DAPT duration after coronary stenting (Valgimigli et al, 2015). It revealed considerable uncertainty over optimal duration of DAPT after stenting and therefore called for updated recommendations for practising physicians to guide treatment decisions.

Neglected populations

Alongside conflicting results in the published literature on DAPT, there is also limited evidence on various patient subsets—such as elderly patients—who may have a greater bleeding risk. Here, the benefits and risks of DAPT may be different to those seen in more selected patient cohorts included in randomised controlled trials. The aim of this Focused Update therefore is to address the current recommendations on DAPT in patients with CHD.

Dual antiplatelet therapy

Being one of the most intensively investigated treatments in cardiovascular medicine, there have been 35 randomised clinical trials of DAPT, including more than 225 000 patients. The first randomised clinical trial to establish the superiority of DAPT over anticoagulant therapy among patients undergoing percutaneous coronary intervention was published in 1996.

Platelets are small particles in the blood that can clump together to form clots; these can go on to cause myocardial infarction or the occlusion of a coronary stent. Antiplatelet agents are a class of drugs that are used to stop platelets from forming these clots. The use of two types of antiplatelet agents to prevent blood clotting is known as DAPT (American Heart Association, 2017).

The number of patients requiring dual antiplatelet therapy consisting of the combination of aspirin and an oral inhibitor of the platelet P2Y12 receptor for adenosine 5’-diphosphate has increased over time. In Europe, it is believed that around 1 400 000 patients per year may have an indication for DAPT after coronary intervention, and 2 200 000 after myocardial infarction.

P2Y12 inhibitors range from safer drugs, such as ticlopidine or clopidogrel, to the more potent and predictable, such as ticagrelor or prasugrel. The decision on when to initiate a P2Y12 inhibitor depends on both the specific drug and the disease.

DAPT reduces the risk of stent thrombosis from occurrences ranging from acute to late events. It also reduces the rate of spontaneous myocardial infarction after percutaneous coronary intervention and myocardial infarction.

For patients with stable CHD treated with percutaneous coronary intervention, the default P2Y12 inhibitor is considered to be clopidogrel. It is also commonly the default drug for patients with indication to concomitant oral anticoagulation, and in patients with acute coronary syndromes in whom ticagrelor or prasugrel are contraindicated. Ticagrelor or prasugrel is recommended in people with acute coronary syndromes unless drug-specific contraindications exist.

Recommendations for DAPT

A Task Force made up of selected medical experts carried out a comprehensive review of the published evidence for management of CHD according to ESC Committee for Practice Guidelines policy, and approved by the EACTS. A critical evaluation of diagnostic and therapeutic procedures took place, including assessment of the risk–benefit ratio. The level of evidence and the strength of the recommendation of particular management options were then weighed and graded according to predefined scales.

The Focused Update recommends a default DAPT duration of 12 months for patients with acute coronary syndrome. This is irrespective of revascularisation therapy, whether through medical therapy, percutaneous coronary intervention or coronary artery bypass surgery. In patients with high bleeding risk, 6 months of DAPT should be considered. Therapy over 12 months may be considered in patients with acute coronary syndrome who have tolerated DAPT without a bleeding complication.

The Task Force felt that the need for a short DAPT regimen should no longer justify the use of bare metal stents instead of newer generation drug-eluting stents. An assessment of the individual patient’s ischaemic risks versus bleeding risks should be used to establish duration of DAPT rather than the type of stent used.

For patients with CHD being treated with percutaneous coronary intervention who are believed to be stable, the duration of DAPT should be 1–6 months, depending on the bleeding risk. This is irrespective of the type of metallic stent implanted. For patients whose ischaemic risk is thought to be greater than the risk of bleeding, the Focused Update recommends a longer DAPT duration. The Task Force felt that there were insufficient data to recommend DAPT in patients with stable CHD treated with coronary artery bypass graft surgery.

The most controversial issue cited was the need for a prolonged DAPT regimen (anything over 12 months) in patients with acute coronary syndrome treated with percutaneous coronary intervention. This is owing to concern over ensuring benefits while diminishing risks.

‘This is a setting in which one needs to think twice about how to maximise the benefits over the risks,’ said Dr Valgimigli. ‘The most novel and important message here is that DAPT is a regimen to treat a patient, not the previously implanted stent. This is crucial and the community needs to adapt to this new treatment paradigm.’

Differing types and durations of DAPT therapy have not been seen as necessary for male and female patients, instead calling for a similar approach to care. Additionally, no difference in therapy is required for patients with diabetes.

Dr Valgimigli said:

‘The Task Force advocates a personalised medicine approach where each treatment and its duration is individualised as much as possible. The document highlights who should, and should not, receive long-term treatment, while at the same time outlining how to maximise the expected benefits over the risks.’

Conclusion

This year marks the 21st anniversary of the first randomised clinical trial that established the superiority of DAPT over anticoagulant therapy among patients undergoing percutaneous coronary intervention. However, differing advice on optimal duration of DAPT after coronary stenting makes this Focused Update long overdue—though it should go some way to guiding treatment decisions. BJCN

References

American Heart Association. 2017. What is Dual Antiplatelet Therapy (DAPT) [Internet]? Available from http://tinyurl.com/yajb9wmx

Valgimigli M, Costa F, Byrne R, Haude M, Baumbach A, Windecker S. Dual antiplatelet therapy duration after coronary stenting in clinical practice: results of an EAPCI survey. EuroIntervention. 2015;11(1):68-74. https://doi.org/10.4244/EIJV11I1A11

Valgimigli M, Bueno H, Byrne RA et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J; 2017. https://doi.org/10.1093/eurheartj/ehx419. [Epub ahead of print]

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

Elderly need to take responsibility for their own long-term health

My Post (6)Elderly people are not doing enough to protect their long-term health and it is having a knock on effect on the NHS. A recent survey found almost a quarter of people aged 65 and over do no strengthening activities at all, and only 9% do them once a week (Chartered Society of Physiotherapy, 2017).

Along with 150 minutes of moderate aerobic activity, national activity guidelines recommend adults over 65 do strength training at least two times a week (NHS Choices, 2015). Working all the major muscles on a regular basis has the benefit of improving daily movement, maintaining strong bones and regulating blood pressure. It is also known to reduce the risk of falls.

Falls cost the NHS more than £2.3 billion a year, not to mention the human cost of pain, injury, and loss of confidence (National Institute for Health and Care Excellence, 2013). It has regularly been highlighted that physiotherapists can greatly reduce the number of falls in the elderly if utilised properly. This is done by a multifactorial assessment of those who may be at risk, followed by a multifactorial intervention to improve strength and balance. As many as 160 000 falls could be prevented if everyone 65 and over at risk of falling was referred to physiotherapy. This would save the NHS £250 million a year (Chartered Society of Physiotherapy, 2014).

While these figures are substantial and illustrate how physiotherapists play a key role in the pathway of care, a simpler solution would be to increase the amount of education in the community in the benefits of strengthening activities. If people were encouraged more and realised how including strengthening activities as part of their weekly routine would affect them, it would reduce the number of people requiring medical attention for falls and take the pressure off health care professionals. The public should be taking responsibility for their own health, yet evidently they are not.

Many adults are put off by the idea of traditional strength training and squirm at the thought of hitting the gym to lift weights. However, this is by no means the only way to gain strength. Recent evidence highlights the benefit of both recreational and non-recreational activities in improving overall health (Lear et al, 2017). Recreational activities that can help to improve strength include yoga, dancing or even heavy gardening. If time is a concern, non-recreational activities such as carrying heavy shopping or doing the housework offer a practical way to build strength. By being mindful of these sorts of activities, the national recommended target can easily be reached.

People need to be inspired to meet these targets, but that is no easy task. However, more can and must be done. The Chartered Society of Physiotherapy’s poll found that advice from a GP or physiotherapist would be effective in encouraging people to meet national guidelines so this needs to be pushed. Additionally, more information is needed, both online and in the community. The public must take responsibility for their own health, but to do that they need to be properly educated.

References

Chartered Society of Physiotherapy. Cost of falls [Internet]. London: CSP; 2014 Sep 2 [cited 2017 Oct 11]. Available from: http://www.csp.org.uk/professional-union/practice/your-business/evidence-base/cost-falls

Chartered Society of Physiotherapy. Too many people letting muscle waste as they age, physiotherapists warn [Internet]. London: CSP; 2017 Sep 29 [cited 2017 Oct 11]. Available from http://www.csp.org.uk/press-releases/2017/09/28/too-many-peopleletting-muscle-waste-they-age-physiotherapists-warn

Lear SA, Hu W, Rangarajan S. The effect of physical activity on mortality and cardiovascular disease in 130 000 people from 17 high-income, middle-income, and low-income countries: the PURE study. Lancet. 2017;pii:S0140-6736(17)31634-3. http://dx.doi.org/10.1016/S0140-6736(17)31634-3

National Institute for Health and Care Excellence. Falls in older people: assessing risk and prevention (CG 161). London: NICE; 2013

NHS Choices. Physical activity guidelines for older adults [Internet]. London: NHS Choices; 2015 July 11 [cited 2017 Oc 12]. Available from http://www.nhs.uk/Livewell/fitness/Pages/physical-activity-guidelines-for-older-adults.aspx

Taken from International Journal of Therapy and Rehabilitation, published November 2017.

Whole system change needed in gender identity services

My Post (5)Gender identity services in the NHS are failing to meet the needs of patients. Huge delays in treatment are forcing many to go private or abroad, while a lack of funding and suitably trained staff means patients are not receiving adequate care.

Gender dysphoria is a condition whereby a person experiences discomfort or distress because there is a mismatch between their biological sex and their gender identity (NHS Choices, 2016). Figures estimate there are 650 000 people in the UK living with gender dysphoria, which is equal to 1% of the population (Women and Equalities Committee, 2016). This is expected to rise as society’s increasing tolerance and acceptance of transgenderism has encouraged more people to come forward and seek medical help.

In the UK, transgender people’s health needs regarding gender dysphoria are being met at specialised NHS gender identity clinics or through private care. At present, all GPs in England, Northern Ireland and Scotland may refer their patients directly to a gender identity clinic, and do not need to refer them to a mental health service for assessment beforehand. In Wales, however, GPs have to refer first to a local psychiatrist, who assesses the patient and can recommend they are referred for assessment and treatment at a gender identity clinic (General Medical Council (GMC), 2017).

Unacceptable waiting times

Waiting times for people with gender dysphoria before their first appointment at an NHS gender identity clinic are unacceptable, as are the times for subsequent gender reassignment surgery, should it be wanted. This, in turn, has a massive impact on the health and wellbeing of trans patients. According to the GMC, the risk of self-harm and suicide for trans people is much greater than in the general population, and any delays in accessing medical care can substantially increase these risks (GMC, 2017).

Under the NHS Constitution, patients are legally entitled to have their first appointment at a specialist service within 18 weeks of referral (Department of Health, 2015). However, due to increased demand, some transgender patients have found themselves waiting up to 4 years for an appointment (Lyons, 2016). Remarkably, it was only in January 2015 that the NHS accepted that the 18-week principle applies to gender identity services too (Women and Equalities Committee, 2016).

It is because of these long waiting times that many trans people are turning to private care—but this does not come cheap. Initial appointments can cost between £220 and £280, and tend to cover assessment, diagnosis and recommendations. It is generally after two appointments that hormone therapy is started.

The cost of gender reassignment surgery varies considerably and prices range from £10 000 to £20 000. In desperation, many are turning to far-flung destinations, such as Thailand, to have this surgery.

Things need to change

In an attempt to meet the increased demand on gender identity services, NHS England invested an additional £6.5 million in this area this year. It is hoped this will go some way to reducing waiting times. However, despite increased funding, there is no detracting from the stark truth that the NHS is letting transgender people down. Notably, according to a Government report on transgender equality, the NHS is ‘failing in its legal duty under the Equality Act’ (Women and Equalities Committee, 2016).

A lack of knowledge and understanding among many clinicians and staff within the NHS has meant transgender people all too often encounter significant problems, whether through prejudice or the provision of inappropriate care. Additionally, other commonly cited concerns include too much variation in clinical protocols, confusion about what is available in the NHS, and inequitable access arrangements (Women and Equalities Committee, 2016).

Following this report, NHS England asked its Clinical Reference Group for Gender Identity to make recommendations on new service specifications for these specialist clinics. This led to a 12-week public consultation on proposals for new service specifications that, if adopted, will describe how specialised gender identity services for adults will be commissioned and delivered in the future within England. The final decisions will be made at the end of autumn 2017.

Relationship between public and private services

Among the changes set out in the consultation include a proposal that only designated specialist gender identity clinics will be able to refer individuals for reassignment surgery in the NHS. This would mean other NHS professionals or private clinics would not be able to make the referrals. The decision was made because it is felt the multidisciplinary teams of gender identity clinics are best placed to consider an individual’s suitability for surgery in the context of the relevant medical, psychological, emotional and social issues (NHS England, 2017). They are also able to accurately gauge the likely range of risks in each case.

Unfortunately this means patients would be unable to begin down the private pathway of care for an initial assessment and diagnosis, before moving to the NHS for gender reassignment surgery. Though this would go some way to diverting pressures on NHS services, it could be argued that boundaries of care between private and public could be blurred, making it difficulty to ensure safety and quality of care. Equally, referrals to an NHS gender clinic would have to come through an NHS pathway.

A gender identity specialism is needed

The lack of suitably trained staff to take on specialist roles being created in nursing, medicine, psychology and other professions is one of the key reasons for unprecedented demand on gender identity services. There are under a dozen people in the UK working both privately and in the NHS who can carry out vaginoplasty or phalloplasty operations (Parkins, 2016).

With the above in mind, there have been discussions with Health Education England, the GMC and the Royal College of Physicians about the development of a gender identity specialism, supported by appropriate curricula and recognition. It is evident that this is sorely needed; however, even at a grassroots level, training for GPs is insufficient, consisting of two online educational modules on gender variance on the Royal College of General Practitioners’ website. Without a proper understanding of this patient population, health services cannot begin to address their needs.

Conclusion

While momentum for change is gathering and the Government is beginning to listen, anything short of a whole system change in gender identity services would be insufficient. Waiting times are the most pressing concern that need to be addressed, with demand and capacity out of balance. Quality indicators are needed to assess quality and benchmark providers; a better interface with primary care services is essential; and increased understanding and knowledge across all health services is paramount. Transgender people have just as much right to care as anyone else, and health services and professionals cannot let them down.

References

Department of Health. NHS Constitution for England. 2015. http://tinyurl.com/d7sa3wq (accessed 23 October 2017)

General Medical Council. Good medical practice. Trans healthcare. Treatment pathways. 2017. http://tinyurl.com/grugw8z (accessed 19 October 2017)

Lyons K. Gender identity clinic services under strain as referral rates soar. 2016. http://tinyurl.com/hcb9uzz (accessed 19 October 2017)

NHS Choices. Gender dysphoria. 2016. http://tinyurl.com/ybt7rbj7 (accessed 19 October 2017)

NHS England. Guide to consultation: specialised gender identity services for adults. 2017. http://tinyurl.com/ydg3pfmh (accessed 19 October 2017)

Parkins K. Meet the gender reassignment surgeons: ‘Demand is going through the roof’. 2016. http://tinyurl.com/hdblcpg (accessed 19 October 2017)

Women and Equalities Committee. Transgender equality: first report of session 2015–16. 2016. http://tinyurl.com/y8sftc2h (accessed 19 October 2017)

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