In 2002, I had just completed a randomised trial with the notorious drug thalidomide for the cancer, multiple myeloma. Thalidomide would later be FDA approved on the basis of this trial. As a young investigator I was thrilled with the success and eager for the next exciting trial testing fancy new regimens.

But a patient with myeloma, Mike Katz, had other ideas. 

Mike was on national patient advocacy committees. He had battled myeloma for years and knew all of the recent advances. More importantly he attended numerous patient support group meetings and had his finger on the pulse of what myeloma patients were going through.

Mike was also on the ECOG-ACRIN Cancer Research Group and the National Cancer Institute myeloma committee and listened as we debated ideas for the next myeloma trial.

While doctors talked about creating “exciting” combinations, Mike said, “Listen, what patients really want is freedom from the side effects of Dexamethasone.”

He said, “All these new drugs don’t help if patients cannot take them. You guys are giving too much Dexamethasone. And people are suffering.”

Dexamethasone was used in myeloma at high doses to kill the cancer cells. It was an important component of therapy.

Mike disagreed.

“You are giving Dexamethasone at a high dose on the basis that this is how it has always been done. Please run a trial and see if in the era of new drugs you still need such high doses of Dexamethasone.”

We were all sceptical. But Mike was not going to give up. He insisted we do a randomised trial of high dose Dexamethasone versus low dose dexamethasone.

To us the idea seemed destined to fail. It seemed so boring. We had waited 40 years for new drugs and Mike wants us to test Dexamethasone  dosing!

However, we respected Mike. We knew he was aware of what patients were going through. We saw 100-200 myeloma patients a year. He interacted with thousands. He was also leading meetings of support group leaders who were leading meetings with lots of other myeloma patients.

So we proceeded to convince the National Cancer Institute and ECOG-ACRIN Cancer Research Group leadership that testing the optimal dose of Dexamethasone was the most important publicly funded randomised trial. Rafael Fonseca took the lead.

It wasn’t easy. But we got it approved.

Long story short, the trial accrued faster than any other myeloma trial we had done in national cooperative groups ever!

Deaths with high dose Dexamethasone (control, standard of dare arm) were significantly higher than with low dose dexamethasone!

We had hypothesised that by using low dose Dexamethasone we will have less toxicity and similar efficacy. Little did we know that just a change in Dexamethasone dose would save lots of lives: At one year 96% were alive with low dose Dexamethasone  versus 87% with high dose standard of care Dexamethasone.

There were other benefits as expected. All serious side effects including blood clots were lower with low dose Dexamethasone.

The Lenalidomide plus low dose Dexamethasone (Rd) regimen was born. The little “d” signifies low dose Dexamethasone.

Rd is now the backbone of most myeloma regimens. The lower dose of Dexamethasone has allowed us to build many 3-4 drug combinations.

We are indebted to Mike. We grieve his loss. His legacy and work with ECOG-ACRIN Cancer Research Group, the American Society of Clinical Oncology (ASCO), the National Cancer Institute, the National Institutes of Health and the International Myeloma Foundation endures.

The ASCO honored Mike in 2014 with the Partners in Progress Award. He narrated this story when he accepted the Award at the ASCO Annual Meeting.   

Our randomised trial of high dose versus low dose Dexamethasone was published in The Lancet Oncology and is one of the most cited myeloma papers ever with over 1000 citations.

Here is his son Jason sharing his father‘s story.

Let’s imagine that you’re in your early 70s and you have a few chronic health problems. Your mobility has been getting worse due to arthritis in your hip. You’ve tried pain killers, had some physiotherapy and now use a stick but the pain and restriction in your function is getting you down. Your GP refers you to your local hospital to see an orthopaedic surgeon to discuss surgery. How do you know if having surgery is the right decision for you?

On the face of it the decision may seem easy; have the surgery to cure the problem. Indeed many, or even most of us, would choose this option to be rid of the pain. What, however, about the short- and long-term risks of surgery? We know that with increasing age, and in particular with increasing number of chronic health problems, the medical risks associated with surgery increase. That is to say, the surgical procedure, the hip replacement itself, may go smoothly but the overall process of surgery, anaesthesia and hospitalisation may make existing medical problems worse or create new ones. This is a situation that hundreds of older people face each week in the UK, and as the population ages and advances in medicine and surgery increase, will become even more common. However, quantifying these risks has been a major challenge for researchers to date.

The Optimising Shared Decision Making In high RIsk Surgery (OSIRIS) research programme is funded by the National Institute of Health Research (NIHR). We’re focussing on the group of older patients who often have significant chronic health issues and are at greater risk of complications around and after surgery. We’re asking some big questions about how these patients and their doctors currently make decisions about major surgery and how we could improve that process. We are also looking at the data on over 5 million patients to truly understand what happens to older patients in the year after surgery. This will then allow us to develop a tool to forecast and present risks associated with surgery. This will be tested in a trial across UK hospitals, to see if it improves the decisions people make.

Presenting a more detailed risk forecast to patients will help them to understand how the choice about surgery may specifically impact them and their lives and so support genuine shared decision-making. Surgery improves the lives of millions of people a year around the world, but it is not without risks and patients and doctors need to be more aware of these and be able to discuss them openly. The outputs of the OSIRIS research programme will help increase that awareness and allow people to make informed decisions where all the risks can be weighed up against all the benefits.

Shared decision making and informed consent are hot topics right now in the health care professions and in the media. We’re 2 years into our 6-year research programme and we already know so much more about the decision-making process and how we might improve this. Ultimately, doctors need access to better, more individualised information and patients need to be presented this information in a way that is clear and comprehensible. We are very hopeful that OSIRIS will provide a model to empower patients to make a major decision that is right for them. Watch this space!

You can find out more about the research by visiting the OSIRIS Programme website or following @osirisprogramme on Twitter.

If you'd like to share your thoughts on any of the issues raised in the blog or another patient safety topic, please get in touch with Patient Safety Learning by emailing content@pslhub.org or leave a comment below. 

The NHS Patient Safety Strategy identifies the involvement of patients in patient safety “throughout the whole system” as a key part of achieving its future patient safety vision.[2] The strategy includes plans to create a patient safety partners framework; earlier this year, the NHS published a consultation on its draft Framework for involving patients in patient safety.[3]

In this blog, we will provide a summary of our feedback to the consultation. You can find our full submission at the end of this blog.

Involving patients in their own safety

The NHS Framework is divided into two parts, the first of which sets out the broad approach that should be taken to involving patients in their own healthcare and safety. We particularly welcome its emphasis on: encouraging patients to ask questions; if problems occur, the importance of providing information and help to maintain patients’ safety; the role of patient incident reports and complaints as a source of learning. 

In our response, we fed back with our thoughts on improvements in two specific areas - complaints and patient safety incident reporting.

Complaints

We share the view set out in the Framework that patient complaints should be viewed as  “a valuable resource for monitoring and improving patient safety”.[3] We believe it’s important the Framework is joined up with the ongoing work of the Parliamentary and Health Service Ombudsman (PHSO), who have recently completed a consultation on a new Complaints Standard Framework for the NHS.[4] We believe that this presents an opportunity to embed patient safety into these processes and we responded to the PHSO consultation highlighting this.

Patient safety incident reporting

The Framework highlights the importance of patients reporting patient safety incidents, noting that the future introduction of a new Patient Safety Incident Management System will create “new tools to more easily participate in the recording of patient safety incidents and to support national learning”.[3]

We believe more needs to be to be done to address the cultural barriers that deter patients from reporting concerns. Patients, carers and families need to feel assured that their stories and testimonies are welcome. Alongside this, it is crucial that, when concerns are reported, they are used to inform the assessment of risk and patient safety. As noted in the Cumberlege Review, not only are incidents not being reported but the existing systems “cannot be relied upon to identify promptly significant adverse outcomes arising from a medication or device because it lacks the means to do so”.[5]

Patient Safety Partners

The second part of the Framework is concerned with the newly proposed role of Patient Safety Partners (PSPs) in NHS organisations. PSPs would formally participate in safety and quality committees, patient safety improvement projects and investigation oversight groups. In our consultation response, we highlighted several areas where we feel these proposals require strengthening if they are to be successful. 

Training and guidance for staff

The Framework rightly acknowledges the importance of having appropriate training and guidance for staff to help support the new PSP roles, pointing towards the new National patient safety syllabus as a key source. We have concerns that the National patient safety syllabus, in its current form, does not have a strong enough focus on patient involvement to provide this support. We highlighted the need for a greater emphasis on the skills and knowledge required to understand why and how patients can be actively involved in patient safety in our response to the consultation on the draft syllabus earlier this year.[6] 

We believe the syllabus could be significantly strengthened by drawing on further research and resources available in this area, such as the World Health Organization (WHO) Patient Safety Curriculum Guide.[7]

Support and peer networks for PSPs

We believe there needs to be more clarity about the induction and training that would be made available to PSPs. We also make the case that PSPs need access to networks with their peers PSPs in other organisations, enabling them to share good practice for safety improvement and receive support from others. We believe that it would be beneficial to create these networks alongside the new PSP roles. 

We suggest it would be helpful to draw on experiences of other programmes involving patients in patient safety, such as the WHO Patients for Patient Safety programme in the UK and the Canadian Patients for Patient Safety programme.[8] [9]

Patient Safety Specialists

The Framework makes brief reference to the relationship between future PSPs and the newly proposed Patient Safety Specialists, which all trusts and CCGs have been asked to put in place by the end of November.[10] We believe that if Patient Safety Specialists are to work effectively in organisations then these roles will need to be filled by leaders with expertise in patient engagement. Responding to a consultation earlier this year, we commented that those filling these roles will need strong skills and experience.[11] We also believe the Framework should place a great emphasis on the role of Patient Safety Specialists in supporting the work of PSPs.

Co-production

In our feedback, we also argue that there should be a strong emphasis on co-production with PSPs and more broadly throughout this Framework. ‘Co-production’ is an activity, an approach and an ethos which involves members of staff, patients and the public working together, sharing power and responsibility across the entirety of a project.[12] In our view, projects and patient safety programmes should always be co-produced with patients where possible.

What needs to be included in the Framework

As well as commenting on the specific proposals of the Framework, we identified two additional areas which we believe should be added to it:

       1. Measuring and monitoring performance

Patient Safety Learning believes that, to make improvements in the involvement of patients in patient safety, we need to be able to clearly measure and monitor our progress. Publicly reporting on changes and improvements made through patient involvement and patient safety allows for sharing examples of good practice. It would also mitigate against concerns that the role of PSP could become tokenistic in some organisations, resulting in little real impact.

      2. Restorative Justice

Many national healthcare systems and organisations are actively listening to, and engaging with, patients for learning through restorative justice. Restorative justice in healthcare allows patients to be heard, listened to, and respected. By patients, clinicians, healthcare leaders and policy makers engaging with one another on patient safety, it can help to establish trust with the patient. This can also provide the impetus for learning and action to be taken to prevent future harm. We commend the approach adopted by New Zealand’s Ministry of Health in how it responded to harm from surgical mesh and the impact this has had on improvements in patient safety.[13]

Closer to home, there are some beacons of good practice within the NHS, such as the Mersey Care NHS Foundation Trust.[14] We believe that the NHS should do more to share and promote a just and learning culture, asking organisations to develop and publish goals on their progress.

Only one piece of the puzzle

We welcome and recognise the positive steps being set out in the Framework to improve patient involvement in patient safety within the NHS. Our comments and suggestions for improvement are mainly centred around the need to ensure other key pieces are in place.

Significant change is still needed. The Framework focuses on increasing patient involvement in governance and decision-making. This wider need for change in how we engage patients in patient safety is outlined in the recently published WHO Global Patient Safety Action Plan 2021-2030.[15] It promotes a range of actions for governments and healthcare organisations to help engage patients and their families in patient safety; we would expect to see this reflected in the work of NHS England and NHS Improvement.

Strengthened as we suggest, we believe that the Framework could make a big difference to improving patient involvement with patient safety.

References

1. Patient Safety Learning. The Patient-Safe Future: A Blueprint for Action, 2019. 
2. NHS England and NHS Improvement. The NHS Patient Safety Strategy: Safer culture, safe systems, safer patients, July 2019. 
3. NHS England and NHS Improvement. Framework for involving patients in patient safety, 10 March 2020. 
4. PHSO. Making Complaints Count: Supporting complaints handling in the NHS and UK Government Departments, July 2020. 
5. The Independent Medicines and Medical Devices Safety Review. First Do No Harm, 8 July 2020. 
6. Patient Safety Learning. Patient Safety Learning’s response to the National patient safety syllabus 1.0, 28 February 2020. 
7. World Health Organization. Patient Safety Curriculum Guide, 2011. 
8. Action Against Medical Accidents. Patients for Patient Safety, Last Accessed 15 October 2020.
9. Canadian Patient Safety Institute, Patients for Patient Safety Canada, Last Accessed 16 October 2020. 
10. NHS England and NHS Improvement. Patient Safety Specialists, Last Accessed 15 October 2020. 
11. Patient Safety Learning. Response to the Patient Safety Specialists consultation, 12 March 2020. 
12. Dr Erin Walker, What should co-production look like?, 1 April 2019; National Institute for Health Research, Guidance on co-producing a research project, March 2018. 
13. Jo Wailling, Chris Marshall & Jill Wilkinson. Hearing and responding to the stories of survivors of surgical mesh: Ngā kōrero a ngā mōrehu – he urupare (A report for the Ministry of Health). Wellington: The Diana Unwin Chair in Restorative Justice, Victoria University of Wellington, 2019. 
14. Mersey Care NHS Foundation Trust. Just and Learning Culture – What it Means for Mersey Care, Last Accessed 16 October 2020. 
15. World Health Organization. Global Patient Safety Action Plan 2021-2030: Towards Zero Patient Harm in Health Care, 28 August 2020.

How could the best ideas emerging during the pandemic, be nurtured and grown?

This report Keeping the conversations alive during the pandemic to build the future of health and social care looks at how they have managed to maintain the momentum of their work at such an important but challenging time.

The qualitative phase expands the understanding of the quantitative results from a previous study by broadening the knowledge on external barriers and internal barriers that patient organizations face when implementing PV activities. The strategies to stimulate patient-organisation participation are the creation of more awareness campaigns, more research that creates awareness, education for patient organisations, communication of real PV examples, creation of a targeted PV system, creation of a PV communication network that provides feedback to patients, improvement of understanding of all stakeholders, and a more proactive approach from national competent authorities.

Both study phases show congruent results regarding patients’ involvement and the activities patient organisations perform to promote drug safety. Patient organisations progressively position themselves as stakeholders in PV, carrying out many activities that stimulate awareness and participation of their members in drug safety, but still face internal and external barriers that can hamper their involvement.

It would be easy and obvious to cite Covid as the reason for this, but surely the current pandemic is all the more reason for the importance of patient safety to be integral to our planning and priorities as we restart and reset services and look to the future.

The report made several key recommendations across a number of devices, procedures and drugs. The main themes were to:

• involve patients more in their care and to listen and take their views seriously
• move away from a culture of blame so that staff could speak up and voice concerns
• improve data collection and incident reporting to aid learning
• provide more support to patients after things have gone wrong
• better address health inequalities
• improve leadership and regulation.

It is one of several reports in the last 20 years that has considered patient safety scandals and sought to address this persistent and fundamental problem within healthcare. It is not just a UK problem, the OECD estimates 15% of healthcare budgets are spent on harm, much of it entirely preventable, and the remainder on rectifying or compensating for the problems created.

Within the Cumberlege report was this quote:

"I have to say 20 years later it is very frustrating how little progress we have made. It’s clear to me that we still have not got the leadership and culture around patient safety right. As long as you have that culture of people trying to hide things - then we are not going to win this."
Professor Ted Baker, Chief Inspector of Hospitals, CQC

At this time of unprecedented change, with an acceleration of acceptance and adoption of innovation and technologies like never before, surely now is the time to bring patient safety to the fore of the debate about how our healthcare services should be run and managed. If it is not deemed important now will it ever truly be important? Or will it remain forever in the camp of “too difficult” to solve?

To ensure the safety of patients we should also recognise the need for people and organisations to share learning when they respond to incidents of harm, and when they develop good practice for making care safer. Patient Safety Learning’s the hub plays an important part in this, providing a platform to share resources, stories and good practice for anyone who wants to make care safer for patients.

At PEP Health (Patient Experience Platform), we have one of the largest databases of patient comments tracking back to Jan 2018. It covers every hospital in the UK and includes every comment made by patients across social media platforms and online review sites. Our analysis of these comments demonstrates that what patients say matters and that patients provide remarkable insight and perspective. It also highlights that patient experience and patient safety are not two discrete components of “quality” but are closely interwoven and linked. For example, we hear patients commenting on issues such as repeated medicine errors, an inability to access essential services and being provided with either poor or confusing information

So, in the spirit of starting some discussion following the Cumberlege report, here are my recommendations and thoughts:

1. Without better, faster data to support change nothing will happen. This data needs to be a balance of quantitative and qualitative data that brings together patient safety, patient experience and the patient voice.
2. A patient safety commissioner can provide leadership but they cannot change the culture alone. After so long trying internally without success, we should now publicise results and be more transparent than ever before. Organisations should be benchmarked and compared against their peers.
3. Greater celebration and promotion should be made of successes. Best practice and learning is too slow to take hold. Teams should not only be encouraged to adopt change but be empowered to make change locally.

The patient voice must be taken much more seriously by organisations and clinicians so that in 20 years’ time we are still not publishing reports following scandals with little change to celebrate and few lessons learnt.  

Being A Patient investigated possible new approaches to capturing patient experience, which go beyond the traditional model of evaluating the experience of receiving care, and instead consider the experience of living with a health or care need. So far we have suggestions for possible new factors to consider, including the nature of a person’s illness and its impact on their life.

This report completes the first stage of the patient experience programme.