Search the hub

Workers tasked with specific responsibilities around patient and public involvement (PPI) are now routinely part of the organisational landscape for applied health research in the United Kingdom. The National Institute for Health and Care Research (NIHR) has had a pioneering role in developing a robust PPI infrastructure for publicly funded health research in the United Kingdom. However, there are still considerable barriers to embedding worthwhile and sustainable public input in the design and delivery of research. Notably, researchers and healthcare professionals report a tension between funders’ focus on deliverables and the resources and labour required to embed public involvement in research. This study explored this issue and found five overarching themes which signal a growing tension between expectations put on staff in PPI roles and the structural limitations of these roles: the instability of support the production of invisible labour PPI work as more than a job accountability without control delivering change without changing.

The paradox of representation in public involvement in research is well recognised, whereby public contributors are seen as either too naïve to meaningfully contribute or too knowledgeable to represent ‘the average patient’. Given the underlying assumption that expertise undermines contributions made, more expert contributors who have significant experience in research can be a primary target of criticism. Knowles SE et al. conducted a secondary analysis of a case of expert involvement and a case of lived experience, to examine how representation was discussed in each. Data both from interviews with researchers and reported observations by the Panel indicated that representation was a concern for researchers in both cases. Consistent with previous research, this challenge was deployed in response to contributors requesting changes to researcher plans. However, we also observed that when contributor input could be used to support research activity, it was described unequivocally as representative of ‘the patient view’. We describe this as researchers holding a confirmation logic. By contrast, contributor accounts enacted a synthesis logic, which emphasised multiplicity of viewpoints and active dialogue. These logics are incompatible in practice, with the confirmation logic constraining the potential for the synthesis logic to be achieved.

In this blog, peer researchers Saffron, Bianca and Alysha describe their involvement in a study about violence and mental health funded by the UKRI Violence, Abuse and Mental Health Network. The study looked at how adolescents’ experiences of violence and neighbourhood disorder—such as vandalism and muggings—affects their mental health as they move into adulthood. As peer researchers, they helped analyse data and used their lived experience to interpret the findings and co-author an academic research paper. They highlight the value of involving people with relevant lived experience in research studies.

The Health and Social Care Select Committee have published a new report reviewing the progress that the UK Government has made in implementing the recommendations of the Independent Medicines and Medical Devices Safety Review, sometimes referred to as the Cumberlege Review. This blog sets out Patient Safety Learning’s reflections on this report. The Independent Medicines and Medical Devices Safety (IMMDS) 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. These interventions have resulted in a truly shocking degree of avoidable harm to patients over a period of decades, with the Review describing the healthcare system’s response to this as “disjointed, siloed, unresponsive and defensive."[1] Over two years on from the publication of the IMMDS Review’s report, First Do No Harm, the Health and Social Care Select Committee has today published a new report reviewing the implementation of its recommendations to date.[2] The Review made nine overarching safety recommendations, of which the Government accepted four in full, two in part, one in principle and rejected two.[3] Following an evidence session held on 13 December 2022, the Health and Social Care Select Committee’s report focuses specifically on two of the three medical interventions considered by the IMMDS Review, sodium valproate and pelvic mesh implants, and makes recommendations for Government action on these issues. Implementing recommendations The Committee’s report highlights the need to ensure that the below recommendations of the IMMDS Review, which the Government accepted, are fully implemented: That the Medicines and Healthcare products Regulatory Agency (MHRA) substantially revises its approach, particularly in relation to adverse event reporting and medical device regulation and ensures that it engages more with patients and their outcomes. A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. That it sets up a register of clinicians’ interests and ensures this includes financial and non-pecuniary interests for all doctors. That it establishes a register of industry payments to clinicians. Ensuring that the MHRA is responsive to patients and their outcomes is a long-term piece of work. The MHRA has come forward with numerous activities aimed at improving its approach in this respect, including the introduction of a new Patient Involvement Strategy.[4] While the jury is still out on what the impact of this will be, Patient Safety Learning believes that to meet the Review’s recommendation will require more than just increased patient involvement; it will mean meeting patients’ expectations that healthcare products are safe and that patients are free from avoidable harm. Turning to the creation of a central patient-identifiable database and a register of industry payments, there has been a lack of significant progress on these recommendations to date. However, pilot work on the register of clinicians’ interest has taken place and it has been stated by the Minister Maria Caulfield MP that implementation of this will begin in 2023. On each of these recommendations, we support the Committee’s calls for increased urgency by the Government in regards to their implementation. We also believe that there should be openly published timetables setting out plans for this. You can read more about the importance of registering of clinicians interests, industry payments to clinicians and the need for greater transparency and reporting around financial conflicts of interest in healthcare in a blog on the hub by Sling the Mesh founder Kath Sansom.[5] Redress A central focus of the report is the need for greater support for the women and children affected by the medical interventions covered by the IMMDS Review. Related to this, one of the key recommendations of the Review was to establish a new independent Redress Agency for those harmed by medicines and medical devices. It was envisioned that: “The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.”[1] However, the Government rejected this recommendation, along with a recommendation to establish separate redress schemes for patients adversely affected by hormone pregnancy tests, sodium valproate and pelvic mesh. Instead they pointed towards patients having the right to take healthcare providers to court through clinical negligence, or manufacturers through product liability. Patient Safety Learning believes, like many individual patients and patient groups, that this response was wholly unsatisfactory. A new blog published on the hub this week highlights how for many harmed patients affected by the interventions considered in the report the clinical negligence route simply is not viable.[6] In the absence of any system of redress, this leaves them with no assistance to help meet the cost of any additional care and support they may need. The Committee’s report notes that the Minister Maria Caulfield MP has indicated that she is willing to look at the idea of a Redress Agency, as well as separate redress schemes. We would welcome this and support the Committee’s call for a formal statement on this with “more details on what such a review would include and seek to achieve, and timeline for completion”.[2] Audit of mesh patients Another recommendation of the IMMDS Review was for a retrospective audit of women who had pelvic mesh surgery, to help gain a fuller understanding of the nature and extent of mesh associated complications, with this data informing decisions over future pelvic mesh surgery. The Committee’s report notes that while this audit is underway, there are significant concerns that it is failing to adequately capture mesh related complications due to the data it draws on. The report therefore recommends that the Government “consider an alternative strategy for how to pro-actively contact those who have had the procedure about their post-operative experiences and possible side effects.”[2] Patient Safety Learning supports this recommendation, which echoes the IMMDS Review’s intentions that as part of this audit: “Every effort should be made to obtain sufficient data, and the audit results (assuming it is feasible) should be used to inform decisions over the future of pelvic mesh surgery.”[1] Patient Safety Commissioner The Committee’s report also stresses its support for the work of the new Patient Safety Commissioner for England, Dr Henrietta Hughes, urging the Secretary of State to ensure her duties and responsibilities are not impeded by a lack of resource for and within her office. It suggests that any additional work she may be tasked with relating to reviewing redress arrangements should be accompanied by additional resources. Patient Safety Learning supports this recommendation. The Patient Safety Commissioner can play an important role in helping to tackle unsafe care and empowering patients; however, her office must have the necessary resources and support to achieve this as indicated by the Select Committee. Engaging with patients At Patient Safety Learning, we believe that patient engagement is key to improving patient safety and identify this as one of the six foundations of safer care in our report, A Blueprint for Action.[7] Patients should be engaged for safety at the point of care, if things go wrong, in improving services, advocating for changes and in holding the system to account. We concur therefore with the Committee’s calls for the Department of Health and Social Care to improve its approach to this, following concerns raised by patients and patient groups: “We are concerned that although the letter from the Department seems to outline various interactions and consultations with stakeholders, and mentions Sling the Mesh by name, this is not the experience of some patients. Patient input is vital in setting up care schemes such as this one. We therefore urge the Department to reflect on the experience of some of the stakeholders with lived experience in this instance, and to consider how to improve engagement with them in the future.”[2] Hormone pregnancy tests One area of disappointment though that we would note with the Select Committee’s report is that it does not consider any of these issues in relation to patients and family members affected by hormone pregnancy tests, one of the three interventions covered by the IMMDS Review. They state that they were unable to do so due to ‘ongoing litigation’. Patient Safety Learning does not believe this is acceptable. Many of the issues covered by this review, such as reforms to the MHRA, a register of clinicians’ interests and industry payments and potentially revisiting proposals for an independent Redress Agency, equally concern those affected by hormone pregnancy tests. While this may be complicated in some areas by ongoing legal proceedings, the exclusion of this group of patients is in our view impossible to justify. You can read more about this issue, and the work being done by patients and groups to fight for justice and improve patient safety, in an interview on the hub with the Chair of the Association for Children Damaged by Hormone Pregnancy Tests, Marie Lyon.[8] References The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020. Health and Social Care Select Committee, Follow-up on the IMMDS report and the Government’s response: Sixth Report of Session 2022-23, 20 January 2023. Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 23 July 2021. MHRA, Patient Involvement Strategy 2021-25, 1 October 2021. Kath Sansom, No such thing as a free lunch – why recording conflicts of interests must be mandatory, 9 April 2021. Kath Sansom, The difficult of medical negligence cases and why financial redress from the Government is so important for mesh victims, 17 January 2023. Patient Safety Learning, The Patient-Safe Future: A Blueprint for Action, 2019. Patient Safety Learning, Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, 22 February 2022.

Dr Henrietta Hughes, England's Patient Safety Commissioner, discusses how the experiences of people from Black and minority ethnic groups has worsened since the pandemic and how this has impacted on patient safety, in a blog for the NHS Race & Health Observatory.

In this article, published by Patient Satisfaction News, author Sarah Heath argues that more needs to be done to address the power imbalance between patients and providers. She discusses the dangers of a paternalistic approach and why patient engagement and shared decision making is key to patient safety.

This report by the Patient Experience Library explores the reasons why the healthcare system in the UK has failed to listen to and learn from patient experience. It highlights how the NHS – at an institutional and cultural level – fails to take patient experience evidence seriously enough. It also identifies steps that would strengthen evidence-based practice and ensure that the patient voice is better heard.

This paper, published in the Journal of Health Services Research & Policy, examines the potential of combining insights from patient complaints and staff incident reports for a more comprehensive understanding of the causes and severity of harm. In their conclusion, the authors state that this study demonstrates the value of using patient complaints to supplement, test and challenge staff reports, including to provide greater insight on the many potential factors that may cause unsafe care.

Mesh survivors Katherine Cousins and Mary McLaughlin talk about their ongoing fight for justice for women suffering due to vaginal mesh.

The Framework for Involving Patients in Patient Safety (PSP) identifies the requirement for individual organisations to develop local approaches to recruiting, working with and supporting Patient Safety Partners based on the principles provided. As integrated care systems (ICSs) are established opportunities for recruiting PSPs at ICS level to work across the system are being locally considered at system level. A focus group was held in May 2022 with Patient Safety Specialists from both provider and commissioning organisations to discuss the benefits and risks of recruiting PSPs at both provider and system level. This presentation is intended to support organisations when determining the most appropriate approach for their needs. 

The Quality Network for Inpatient Working Age Mental Health Services (QNWA) based within the Royal College of Psychiatrists' Centre for Quality Improvement are pleased to announce the publication of their 8th edition standards. Since the publication of the first edition standards in 2006, the Network has grown to include over 140 members from the NHS and private sector. This new edition of standards aims to reflect the changes in working practices and legislation over the last two years in addition to placing greater emphasis on equality, diversity and inclusion as well as sustainability in inpatient mental health services. The eighth edition standards have been drawn from key documents and expert consensus and have been subject to extensive consultation with professional groups involved in the provision of inpatient mental health services, and with people and carers who have used services in the past.

The Belfast Health Trust failed to intervene quickly enough in the practice of a doctor which led to Northern Ireland's largest ever patient recall, the Independent Neurology Inquiry has found. More than 5,000 former patients of neurologist Michael Watt were invited to have their cases examined for possible misdiagnoses. Among the conditions being treated were stroke, Parkinson's disease and multiple sclerosis (MS). The inquiry found "numerous failures". The Independent Neurology Inquiry concluded that the combined effect of the failures ensured that patterns in the consultant's work were missed for a decade. Key conclusions include: The Belfast Trust should have intervened earlier, but failed to do so. Systems and processes in place to assure the public about patient safety prior to November 2016 failed. The effect of numerous failures ensured problems were missed for many years and opportunities to intervene were lost. Failures not confined to Belfast Trust - information was contained in silos with communications between different organisations and management levels poor and inadequate.

This study, published in the Journal of the Royal Society of Medicine, examines national policies of complaint handling in English hospitals, how they are understood by those responsible for enacting them, and explores if there are any discrepancies between policies-as-intended and their reality in local practice. The study was conducted at a multi-site acute NHS Trust in London, which consists of five acute sites and a range of community services. The Trust is one of the largest in the country, with an average of over 1,000 complaints per year between 2015 and 2019. Key findings of this study included: Confusion and lack of awareness of routes for raising concerns, both among patients and frontline staff. Investigative procedures structured to scrutinise the ‘validity’ of complaints, rather than focusing on improvement. Data collection systems not being set up to effectively support learning from complaints. Adverse incentives and workarounds resulting from bureaucratic performance targets. In the conclusion, the authors note that the study has contributed to existing evidence by demonstrating how challenges to translating complaints into quality improvement can originate from nationally defined policies and regulations for complaint handling. Recommendations for change include patient involvement in complaints investigations, the establishment of independent investigation bodies, and more meaningful data analysis strategies to uncover and address systemic causes behind recurring complaints at national and organisational levels.

The first wave of the pandemic necessitated a large scale shift to greater digital engagement with patients, yet progress has not been uniform. While virtual consultations have become increasingly commonplace, communication outside of those appointments is still often analogue and generally sporadic. Cancelling an appointment – or indicating in advance that a specific day or time doesn’t work – remains a complicated, non-digital experience for many patients. With millions now on waiting lists for treatment, and a significant minority having already waited two years, this sort of communication gap becomes more challenging. As such there are arguments that it’s now time for the digital acceleration seen during the pandemic to extend to this area too.

From the perspective of patient partners, the Ontario SPOR SUPPORT Unit Engaging Multi-stakeholders for Patient Oriented-research Wider Effects and Reach Awards have facilitated successful patient-partnered research projects, which, in turn, have led to an evolution in patient partnerships and engagement strategies. The 15 projects profiled in this special issue point to the beneficial impacts of patient-partnered research. With the SPOR ideals and vision for patient-partnered research, this special edition of the EMPOWER Award studies demonstrates the evolution in patient partnerships and innovative engagement strategies in diverse healthcare research. The EMPOWER Awards were meant to motivate teams to take their patient engagement to a new level. The breadth and depth of the 15 projects reveal the growing appetite to further develop patient engagement strategies and, more significantly, the extent and reach of patient-partnered research. This special edition represents the following topics: priority setting and best practices, equity in patient partnerships, co-designing interventions and tools, tools for patient engagement and patient-driven or community-driven projects. These studies bring to light three fundamental impacts on health research: In partnering with patients, research benefits from identifying unanswered questions, patient-relevant topics and new areas of research. Patient-partnered research influences and shapes knowledge translation strategies and activities. Established patient–researcher relationships provide impetus to continue collaborating. In this special edition, the researchers successfully partnering with patients using co-creation, co-design and co-leadership, and we get a glimpse of the evolution of patient-partnered research. In one project, an empowered patient brought the grant opportunity forward; in another, the community saw the need.

Whether you’re just getting started with involving patients and the public in your work, or if you’re looking for some new techniques, there are some great resources out there. The NIHR have pulled together some of the best available resources to help you involve patients, service users, carers and family members in your research. 

There is a well-described mismatch between the research that is done on a particular condition and the research that patients themselves would like to see done. Formal research priority-setting partnerships aim to reduce this mismatch by involving patients in the selection of topics for research. The National Institute for Health Research (NIHR) has strongly supported patient and public involvement (PPI) in research, produced national benchmarks for PPI, funded INVOLVE (www.invo.org.uk) which promotes patient involvement in all aspects of biomedical research, and written up some exemplar case studies. Trish Greenhalgh looks back at the history of patient involvement in research and suggests a vision for an institute for patient-led research.

A report from the Institute of Health and Social Care Management Power-House series discusses virtual wards, an innovation due to be implemented at scale in the NHS as a method of addressing patient waiting lists. With the help of remote treatment options and supported by technology, patients are monitored and cared for in their own homes. The report lists the advantages and disadvantages of this approach. In addition to the report, you can watch the 'How to virtual wards Power Hour' video where an expert panel discusses the details around virtual wards. Roy Lilley was joined by Professor Alison Leary, Elaine Strachan-Hall, Steph Lawrence, Alexandra Evans and Dr Elaine Maxwell for an unmissable hour of insight, expertise and guidance. Click on video above or view here.

My Planned Care gives you advice and support while you wait and helps you to prepare for your hospital consultation, treatment, or surgery. This includes giving you information about waiting times at your hospital and other supporting and local services while you wait. This site is updated weekly and can be viewed by anyone, which means you, your family or carer as well as your NHS team can all see the latest information. Your hospital team will be in touch with you as soon as they can. If you are looking for an update, please check this website before contacting your hospital or GP.

The Medicines & Healthcare products Regulatory Agency (MHRA)'s first 'Patient Involvement Strategy' sets out how they will engage and involve the public and patients at each stage of the regulatory journey. The MHRA involved patients throughout the process of developing this strategy and carried out a final public consultation before it was published. The strategy identifies five priority areas for the MHRA: Patient and public involvement Responsiveness Internal culture Measuring outcomes Partnerships.