Collaborating with patients, clinicians and manufacturers to deliver better outcomes
As the Cumberlege Review and Paterson Inquiry made clear, having accurate and timely data on treatments and outcomes is critical to patient safety. NHS England is working to strengthen this data by implementing a central database to collect key details of implantable devices at the time of operation. The new Outcomes and Registry Platform will bring existing registries together for the first time and introduce new registries.
The first to go live at the start of 2024 is the new National Registry of Hearing Implants, a registry specifically for cochlear implants. These are electrodes that are inserted into the inner ear to directly stimulate the auditory nerve and provide a sense of hearing for people who are profoundly deaf.
Patients undergoing cochlear implant surgeries can range from very young babies right through to elderly people. The new registry will enable robust comparisons between surgical techniques, implants, surgeons and hospitals. It will also provide an early-warning system for safety concerns and support continued improvement in patient outcomes.
From the start of the project, we have prioritised collaboration between patients, clinicians, regulators and medical device manufacturers. This includes using different techniques, such as focus groups and user journey mapping sessions, to examine current challenges, potential benefits and possible innovations. Patients and representatives from cochlear implant manufacturers also sit on our clinical steering board, guiding the overall direction of the registry.
This collaboration has informed every aspect of our work, including how patient feedback is sought. To be effective, registries need to hold data not just on clinical outcomes but also on how patients feel over time. This information, which covers healthcare outcomes and their perceptions of the overall experience, is collected through surveys at certain points, for example one year and then four years after the implant has been fitted. By understanding patients’ views on the type of information required and the way questions are phrased, we can make sure we communicate to the right people at the right time. Through this, we hope to maximise the number of responses and therefore improve the registry’s effectiveness.
Tricia Kemp is the co-ordinator for the Cochlear Implanted Childrens Support Group and is our patient representative on the steering group and has imputed into registry and patient outcome data collection specifications and data security. ‘It is vital that cochlear implant users and their parents and carers are involved and have the opportunity to input to the development. This will ensure that the views and interests of those whose data is contained within the registry are represented and protected.’
The cochlear implant registry will evolve to include all hearing implants and procedures, for example bone conduction implants. We will continue working with patients, clinicians, regulators and industry to review the data and to roadmap future developments.
Scott Pryde is Programme Director for NHS England’s Outcomes and Registries Programme, and Katherine Wilson is the Clinical Steering Group Chair of the programme.
Universal provision of pre-filled syringes
Primum non nocere (first do no harm) has been a guiding principle of medicine since the days of Hippocrates. Medication errors have been recognised by the World Health Organisation as the commonest cause of preventable harm so it is essential that all steps are taken to reduce their incidence.
However, in my thirty plus years of clinical work as an anaesthetist, the only safety innovation that is routinely available to reduce medication errors has been the introduction of an international standard for user-applied drug labels. This ensures that all hospitals use the same colour scheme for different classes of anaesthetic drugs such as analgesics, hypnotics, or muscle relaxants. But the risk remains that the labelled syringe may contain the wrong drug or wrong concentration due to human error or tampering. This is particularly important for anaesthetic drugs which can have life threatening consequences if incorrectly administered before, during or after anaesthesia. In addition, anaesthesia can be complicated by unanticipated emergencies such as laryngospasm, difficult ventilation, cardiovascular collapse, or severe bradycardia require rapid administration of intravenous drugs. Whilst it is possible to draw up every possible emergency drug to prepare for all eventualities at the beginning of each operating list, this would be wasteful as such situations are relatively rare.
Pre-filled syringes have been shown to significantly reduce the risk of medication error. They are presented in a clinically appropriate doses and concentration and do not require further dilution before administration. The syringes have tamper-proof packaging that is easily unwrapped at the point of use, preventing wastage of emergency drugs. The font size on the syringes is larger than that printed on glass ampoules, making it far easier to read, which is particularly important for presbyopic healthcare providers. The problem is that pre-filled syringes are only available some of the time in some of the hospitals. As a result, we have seen backwards progress in safety standards, with pre-filled syringes being introduced and then withdrawn due to supply chain or budgetary constraints. This began with propofol for total intravenous anaesthesia, which was initially presented in pre-filled syringes which were then replaced by cheaper generic drug vials. It has continued more recently with other drugs such as pre-filled syringes of ephedrine and metaraminol which have been introduced and then withdrawn in many hospitals.
The one thing I would therefore like to see to improve patient safety in anaesthesia is that pre-filled syringes of essential anaesthetic drugs are available in every NHS hospital, all of the time.
Dr Philip Barclay is Clinical Director of Anaesthetics at Chelsea and Westminster Hospital NHS Foundation Trust and chair of the Safety Committee, Association of Anaesthetists
Revolutionising diabetes management
For me, the principles of Type 1 diabetes and good outcomes has always based itself on three planks: self-management, peer support and access to trained professionals. One could argue that this ‘health trifecta possibly extends to any long-term condition.
Technology such as continuous glucose monitors has hinged itself on those planks. A tool whereby one can review glucose levels, check patterns, and adjust based on education gleaned using educational platforms, online forums or peer advice. Throw in the benefits professionals get from the possibility of understanding glucose patterns, applying their knowledge and helping those with Type One diabetes and it is as close to the holy grail of achieving the ‘health trifecta’.
But bringing this to the NHS has been anything but simple. The rise and uptake have been exceptional over the years, beginning from a standing start of around 3% in 2018 to 94% in 2023. Practically universal coverage with low to non-existent deprivation gaps and most importantly, population level shift of glucose markers, the markers for long term risk improvement in diabetes care.
The focus on this from national team has been helpful -as has been the input of NICE via NG 17 and NG18 but the success story would be incomplete if one doesn’t mention the role of those living with Type 1 diabetes and their carers.
The power of the community has been a key driver to help in implementation. Armed by the burgeoning progress of social media, plus podcasts, blogs, not to mention leading figures such as Theresa May or James Norton vocally advocating technology and living with type 1 diabetes. These voices have been difficult, if not impossible, to ignore. Add in the strength of charities and NHS England and the overall impact has been nothing short of spectacular.
From a point whereby the NHS was seen as a confirmed laggard in technology uptake in the world of Type 1 diabetes, it now sits firmly in the forefront of most international data sets. This progress and achievement has led to the next phase – possibly the best thing science can provide beyond a cure to this unremitting condition – is the hybrid closed loop.
The lesson is that if you engage with those who live with long-term conditions and help amplify their needs and voices, you tackle issues such as patient safety and better management. This is an example of what can be done and it’s worth learning from. It is not rocket science.
Partha Kar, NHS England’s National Specialty Advisor for Diabetes
Why insight from patients and families is crucial to every safety investigation
HSSIB exists to investigate patient safety concerns so we can improve healthcare care at a national level. At the heart of this is a professional patient safety investigation that helps us to understand how things are done, how healthcare is delivered, and the factors and circumstances that lead to harm. Simply, if we want to understand what has happened, we must speak to everyone involved.
Patients and those close to them, including family members and carers, are the constant in every healthcare journey. Their insights into the care they experience are unique and essential to understanding how work is done, and how that feels for people receiving care.
Our process of gathering information to support our investigation includes listening to all people involved in a patient safety event. If the patient is alive, this will include them, as well as the people close to them. We do this by meeting with them at a time and place they feel safe to tell us their experience. This is often in their home and always at a time that suits them. We stay in touch. We share our findings and help the patient and/or their family understand what happened and what we have learnt. This takes time and often involves meeting and going through the investigation report page by page. We will always adapt our way of working with people, recognising barriers to communication, and working to address these from the outset and throughout. This ensures our engagement is meaningful, not tokenistic, and tailored to the individual.
If we don’t listen to patients and families through consistent and meaningful engagement, we risk compounding harm already experienced through a patient safety event. By doing this well, patient safety investigations can be a collaborative tool to help all involved move forward after an incident with a shared understanding of how it happened and what has been recommended to make care safer for people in the future.
Healthcare inequalities impact care experience and outcome and this can be true in investigations as well. We tailor our approach for people who are often excluded and under-served to facilitate their involvement. By taking the time to include those previously described as ‘hard to reach,’ the patient safety investigation can have an even greater impact, by amplifying voices and highlighting differences in experience. In our recent investigation ‘Caring for adults with learning disabilities in acute hospitals’ we spoke with over twenty people with a learning disability to help us understand what it was like for them when in hospital.
We know from several reports, reviews, and inquiries over recent years that the patient and family voice has not been heard. These voices are essential to learning and improvement because of their unique insight into how care is delivered. To improve safety we must understand its reality as experienced by patients.
Caring for adults with learning disabilities in acute hospitals (hssib.org.uk)
Rosie Benneyworth is interim chief executive officer of the Health Services Safety Investigations Body (HSSIB)
Top patient safety priority must be to transform the culture of the NHS
In a celebrated and memorable comment, Aneurin Bevan, the founder of the NHS noted that ‘Silent pain evinces no hurt’. In modern parlance that means that if you don’t speak up, injustice is perpetuated.
So it is with the NHS, a priceless national institution resourced by highly skilled professionals who demonstrate their compassion, skill, and forbearance on a daily basis.
And yet there is more than one reality in an organisation that employs 1.4 million people, when persistent staff shortages mean that there is not enough people resource to meet rising demand and staff satisfaction is in a downward spiral.
Evidence from large numbers of Ombudsman investigations, from successive independent inquiries, and, crucially, from the lived experience of significant numbers of bereaved families, is that up and down the country NHS culture militates against joined-up action between clinicians and management in caring for patients and against a listening and learning environment in which trust and transparency are paramount and mistakes are learned from.
This defensive nature of important aspects of NHS culture has resulted too often in individual Trusts placing their own reputation above the primacy of patient safety. Concretely, this means:
- patients and their families not being listened to
- communication between clinicians marred by professional hierarchy and functions
- doctors and nurses who try to raise patient safety issues with management too often being threatened with being reported to their professional regulator on unrelated matters
- senior management and Trust Boards being aware of unacceptable behaviour but taking no corrective action
- too many loyal members of staff working in an atmosphere which they describe as ‘toxic’ or ‘bullying’, adding to the stress already pervasive in the post-COVID environment.
I am interested in learning and accountability. Not in blame. The agenda for action needs addressing urgently and in a joined-up fashion.
In an already overcrowded regulatory field, it cannot be the responsibility of a single regulator but of coordinated action delineated by ministers and implemented through unambiguous NHS England steers.
There are key elements in this necessary package and right at the top is the need to transform culture across the NHS so that it is collegiate, respectful, and well-led, prioritises patient safety and listens to patients and all (including clinicians) who speak up for them. We need NHS leaders at all levels who learn from adverse events and are held accountable not blamed.
Some of this is happening incrementally – for example the new workforce plan, the implementation of Martha’s Rule, objectives for Trust board members and the planned internal review of the duty of candour.
But urgency, coordination, cultural change, focus on leadership development, and cross-party engagement are not obviously being prioritised. It is in all our interests for our prized national asset, the NHS, to receive the joined-up prioritisation it so richly deserves.
Rob Behrens, the outgoing Parliament and Health Service Ombudsman.