The office of Patient Safety Commissioner for England was created by the UK Government following a recommendation from the Independent Medicines and Medical Devices Safety (IMMDS) Review, chaired by Baroness Julia Cumberlege. The Review examined the response of the healthcare system in England to the harmful side effects of three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants.

Role and work of the Patient Safety Commissioner

Opening the meeting, the Patient Safety Commissioner, Dr Henrietta Hughes, outlined the background to her post, explaining that her role is:

• to seek improvements to patient safety around the use of medicines and medical devices
• to amplify patients’ voices and champion the value of listening to patients.

Henrietta noted that much of her initial activities have involved collaborating closely with patients and families impacted by the medical interventions covered by the IMMDS Review.

She spoke about working with Emma Murphy and Janet Williams from the Independent Fetal Anti Convulsant Trust (In-FACT), who have both had children affected by exposure to sodium valproate during pregnancy. She emphasised the importance of their campaigning efforts in helping to support a strengthening of regulations so that valproate medicines cannot be used in women of childbearing potential unless a Pregnancy Prevention Programme is in place. She also spoke about their work with the World Health Organization and other health systems internationally to reduce the risk of children being born exposed to sodium valproate.

She moved on to highlight working with Kath Sansom from Sling the Mesh, who was seriously harmed following a pelvic mesh implant. Henrietta spoke about how the Patient Safety Commissioner’s office had developed, in partnership with the patient campaign groups Sling the Mesh and the Rectopexy Mesh Victims and Support, a letter for patients to help GPs identify the complications of pelvic mesh. It explains signs and symptoms of women presenting with pelvic mesh-related conditions and, if required, where to signpost them for further help.

Talking about her first few months in office, Henrietta said that she had already been contacted about a wide range of safety issues relating to medicines and medical devices, varying from painful gynaecological procedures such as hysteroscopy to the after effects of medications such as isotretinoin.

She also outlined culture change as another key area of initial focus in her work, noting that she was:

• Working with healthcare leaders to ensure the patient voice is heard and making it easier to speak up, tackling the issue of epistemic injustice in cases of healthcare harm where professionals fail to treat patient reports seriously.
• Supporting professions to improve consent and shared decision-making processes, in particular working with all regulators to attempt to align approaches to consent across different healthcare professions.

She spoke about promoting the benefits of patient participation, for patient experiences, outcomes and the wider efficiency of the healthcare system, and the need to strengthen and improve responses to patient feedback. Henrietta also emphasised the importance of patient safety being on healthcare leaders’ agendas, with a greater focus on stopping harm in advance by identifying and managing the causes and controls.

Network discussion

Subsequently the session opened out into a broader discussion of patient safety and patient involvement, in which the following issues were raised:

•  What we can do to move away from an adversarial approach to staff who raise patient safety issues; noting that where this exists for staff it may often be an even greater issue for patients and families.
• Acknowledgement that much more work needs to be done to create a culture where it is safe to speak up. This was highlighted by the latest National Guardian report, which raises concerns from the most recent NHS Staff Survey that we are actually going backward in this area, which Henrietta noted was ‘extremely disturbing’.
• Considering how the healthcare system and organisations can better engage with patients raising safety concerns and valuable insights through groups on social media. Henrietta spoke about the challenge of the hierarchy of evidence when it comes to avoidable harm, where too often anecdotal patient experiences are dismissed when these can provide important patient safety insights.
• The importance of co-production and how you embed this, with an emphasis on the need for true leadership support for this to be successful.
• The value of exploring the role of restorative practice after avoidable harm, with Henrietta noting that she would soon be meeting with a team from New Zealand who have been working on this.
• The need for NHS patient involvement processes to not just focus on the role that staff can play in improving this, but also looking at creating opportunities for patients to raise concerns that do not simply end up in complaints processes.
• The value of patient safety insight and experiences that can be gained from sources external to the NHS, such as Care Opinion.
• The importance of linking up the work of the new Patient Safety Partners in organisations with Freedom to Speak Up Guardians.
• How implementing the new Patient Safety Incident Response Framework (PSIRF) is presenting opportunities to increase and improve patient involvement in incident investigations and gain important insights and learning as part of this.

How to get involved in the Patient Safety Management Network

 Are you a patient safety manager interested in joining the Patient Safety Management Network? You can join by signing up to the hub today. When putting in your details, please tick ‘Patient Safety Management Network’ in the ‘Join a private group’ section. If you are already a member of the hub, please email claire@patientsafetylearning.org.

The findings of this work have resulted in a set of recommendations for national action:

1. It’s OK to Ask – A national campaign should support patients to know ‘It’s OK to Ask’ questions during appointments and prepare questions before appointments.

2. My Planned Care – Non-judgemental information should be co-produced nationally to help people on waiting lists prepare mentally and physically for surgery. This information should be provided in plain language and accessible formats, and added to My Planned Care.

3. About Me – About Me information lets healthcare professionals see at a glance what it is important to patients and supports shared decision making conversations. It should be added to the NHS App and linked to the shared care record.

4. Shared care records – Shared care records need to be implemented without further delay to support shared decision making and patient safety across complex care pathways.

5. Navigating the system – ICBs need to provide a clear description of care pathways in MSK and other conditions and provide consistent information and support to embed shared decision making.

In a recent meeting a spinal surgeon based in Wales told me that some of his patients are expecting to wait 3 years for their planned operation. Other health professionals have told me their patients are waiting anything between 18 months and 2 years.

Around 3000 people in England had been on a waiting list for more than 2 years as of April 2021, as reported by the Kings Fund [1]. More recently (October 2022), the BMA [2] reported that nearly half a million people in England are waiting over a year for consultant-led elective care. While this may come as a shock to many, for those working in the NHS, this is a grim and familiar reality. Even if you aren’t waiting for surgery, you will be aware of the waits for any level of NHS care, be it an appointment with your GP, a call to 111 or perhaps even a medical emergency.

This clearly presents significant risks to patient safety and innovative approaches are being taken across every part of the NHS to mitigate them as much as possible. An area that is of particular interest to me, of course, is patient information.

Lifestyle changes

Strange as it may sound, while waiting months or even years can increase risks, it also presents an opportunity to improve outcomes. Patients are generally advised to maintain a healthy weight, quit smoking, reduce alcohol intake and exercise regularly in the lead up to their operation. If a patient has a long wait for surgery, they have more time to work on these areas.

Studies have proven time and again that positive lifestyle changes can significantly reduce the risk of infection, cardiovascular and pulmonary problems, anaesthesia-related issues, longer hospital stays and more [3]. Recovery is also likely to be faster and smoother if the patient is healthy. Those responsible for supplying information to patients must take advantage of this time to properly educate them on these benefits. The NHS has some online resources that patients can be directed to.

Knowing what to look out for while on a waiting list

A long wait for an operation can be a worry. It can also exacerbate the problem as symptoms worsen with time. Again, information is key here. There is a risk that patients on waiting lists ignore their symptoms as they feel reassured that they are waiting for an operation to resolve them. However, there will be some red-flag symptoms that indicate the patient is in danger of deteriorating if they are not seen urgently by a health professional. It is essential that patients are fully informed of health-related red flags and what to do about them if they occur. It could mean anything from contacting their GP to calling an ambulance.

Our leaflets, designed to support patients deciding about their care, have recently been updated to better inform those on long waiting lists. The leaflets are procedure-specific and so is the waiting list advice. Patients are advised on which symptoms, specific to their condition, to look out for and what to do if they develop or worsen. Information around lifestyle changes has also been elaborated on.

Whether an EIDO leaflet is available or not, this is a really important consideration for all health professionals managing communication with patients on waiting lists. Equally important is regular check-ins from their healthcare team to reassure them and discuss any concerns. This can be particularly helpful if the patient’s mental health is at risk. If patients are not having these check-ins, I would encourage them to ask for them.

A longer lead time between being added to the waiting list and the date of surgery allows patients longer to get themselves ready. It also makes patients more vulnerable to deterioration. High-quality patient information could make the difference between a good and a bad outcome.

References

1. Waiting times for elective (non-urgent) treatment: referral to treatment (RTT). Kings Fund. 5 August 2-21. Accessed online 14/02/23. 
2. NHS backlog data analysis. BMA. Accessed online 14/02/23. 
3. Preparing for an operation with lifestyle changes. Cochrane UK. Accessed online 14/02/23.

Opinions expressed in blogs and other content are those of the author. Patient Safety Learning welcomes sharing content and opinions that promotes safer patient care and for the reduction of avoidable harm.  The views expressed on the hub however do not necessarily represent Patient Safety Learning's views or values. References to a specific product or service does not imply a recommendation or endorsement.

1. Identifying stories for inclusion and exclusion
2. Enabling participation
3. Stages of story collection and publication
4. Video stories
5. Specific considerations when developing a story
6. Governance checklist
7. Consent form
8. Storyteller information
9. Active listening guide
10. Patient Safety Strategy
11. Action planner and tracker
12. Sign-off