Impact case study database

Through industry collaborations, multidisciplinary research by the Skin Health Group has optimised the design of medical devices, ensuring patient safety while maintaining device functionality and delivering further commercial opportunities. It has led to the development of novel monitoring technologies, national policy changes and new international clinical guidelines, all of which have improved pressure ulcer prevention.

Healthcare impact: Optimising device performance to improve patient outcomes

The Skin Health Group’s research (conducted 2014, published 2016) recommended that a modification was required in the range of internal air pressures associated with a fluid immersion mattress system (Dolphin FIS, Jeorns Healthcare, USA), to optimise device performance and patient safety [ 5.1]. The study underpinning [ 3.2] led to changes in the default internal pressure settings of Medstrom’s Dolphin Therapy FIS mattress system and its clinical user guidance [ 5.1]. These changes were defined in 2014 and are now commercially available in all countries in which Dolphin Therapy is distributed, including the USA, Canada, UK and Netherlands [ 5.1]. Medstrom describes Dolphin as a reactive system that allows full immersion and envelopment, significantly reducing pressure, and shear and tissue deformation. Independent evaluations have demonstrated its clinical efficacy for the provision of effective pressure redistribution for individuals both at high risk of pressure ulcers and with existing wounds. A review of 1000 patient outcomes with complex medical conditions (2015-2018) showed that Dolphin was 99% effective at prevention of skin damage in the most complex of patients and 55% of patients experienced a degree of wound healing. Anonymised comments from caregivers included: ‘ Heals faster and is more effective than other air mattresses used within the Trust’; ‘ Patient normally has red marks on all surfaces…no marks since on Dolphin’; ‘ Dolphin Therapy improved comfort levels prior to end-of-life’ [ 5.2].

Healthcare impact: uptake of intelligent pressure monitoring in NHS community settings

Since 2017, the Skin Health Group has collaborated with Cornwall Partnership NHS Foundation Trust on a quality improvement initiative, Pressure Reduction through Continuous Monitoring in the Community Setting (PROMISE). Funded by the Health Foundation, the project deployed the intelligent pressure monitoring sensors (ForeSitePT, XSensor Technology Corp, Canada) that the Group optimised [ 3.4] for patients’ evaluations. Sensors in mattresses and chairs were used to help patients and carers to better understand the positions that are likely to reduce the risk of pressure ulcers, and clinicians were able to monitor patients remotely over prolonged periods for the first time. Using the Group’s advanced understanding of data processing and analysis using Continuous Pressure Monitoring, they trained health professionals on how to use the sensor system, supported clinicians to interpret the pressure monitoring data and provided clinical advice to patients [ 5.3]. By the end of the impact period, the technology had been adopted by four NHS trust sites in Cornwall, Devon and Somerset. It had been used by 88 individuals in their homes; 66% of patients with chronic pressure ulcers had healed or were healing within nine months of using the sensors [ 5.3]. An independent evaluation commissioned by the Cornwall Trust revealed ‘a significant impact on patient care and clinical decision-making’. A Tissue Viability (TV) nurse in Somerset was quoted as saying: ‘It gave me the ability to identify which piece of pressure relieving equipment wasn’t working. We hadn’t been able to do this before and couldn’t have done this without PROMISE.’ A patient said: ‘This Promise thing has been one of the best things we could have got involved in and we’d be in a very different place now if we weren’t.’ [ 5.3].

Healthcare impact: shaping new national and international clinical guidelines to support pressure ulcer prevention and minimise skin damage

Based on their research expertise, the Skin Health Group has taken a leading role in developing international guidelines published by the National Injury Ulcer Advisory Panel (NPIAP), European Pressure Ulcer Advisory Panel (EPUAP) and Pan Pacific Pressure Injury Alliance (PPPIA) in both 2014 (Schoonhoven) and 2019 (Worsley). The Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline is available in 14 languages and represents the leading international consensus to standardise and improve pressure ulcer prevention. Full text guidelines of the latest version (2019) have been downloaded over 6,500 times by healthcare providers around the world (31 countries) [ 5.4]. The Group’s research ‘ had a significant impact on the evidence cited in the guidelines to inform practice’, used widely throughout the guidelines (n=48 citations), in a number of key sections e.g. aetiology, support surfaces and medical devices. The Group has used research insights developed through 3.3 (impact of respiratory masks on facial skin health) to inform key aspects of rapidly released NHS guidelines relating to personal protective equipment (PPE) and Covid-19 [ 5.5]. Published in April 2020 by NHS England and NHS Improvement to protect clinicians from pressure injuries, the guidelines, titled Helping prevent facial skin damage beneath personal protective equipment, include recommendations from the Group on the use of a barrier skin wipe, mask fitting (e.g. do not over-tighten), regular inspection and regular breaks from mask wearing (every two hours).

Economic impact: providing the clinical evidence base for commercial products

Medstrom states that research papers published by the Skin Health Group (including specific mentions of 3.3) have provided ‘ the critical evidence to support our mattress sales’ [ 5.1]. As well as the Dolphin FIS mattress system, this applies to the company’s Aerospacer range, the therapeutic mattress product described in section 2. For the Aerospacer, the physical model evaluation presented in 3.3 enabled the co-development of optimal 3D spacer textiles within a mattress construct to improve the management of microclimate (temperature and humidity at the patient interface). ‘ This had a direct impact on our final design specification,’ the company wrote [ 5.1]. These mattress systems came to market in May 2015 and by the end of the impact period had been used across six NHS hospital sites, resulting in GBP500,000 of revenue [ 5.1].

Commissioned research with one of the world’s largest medical device providers Hillrom (headquartered in the United States) revealed novel information with respect to various mattress features designed to decrease pressure injuries, including: i) An embedded prototype sensor (SAALP™) to optimise settings based on body mass index; ii) Optimal alternating low-pressure signatures to maintain skin health [ 5.6]. Hillrom used the Group’s findings, [ 3.1] ‘ to define technical product specifications and product architecture’ of air mattress systems, resulting in a ‘ direct impact on the successful commercialization and distribution of Hillrom products into new international markets’. These products include the Duo 2 Surface, a dual-therapy low pressure mattress for patients at the highest risk of pressure ulcers, and the ClinActiv+ MCM™, a pressure redistributing therapy mattress system with optimised microclimate management. These were commercialised during the impact period in the US and 14 countries within Europe. In addition, the sensor SAALP™ (Self Adjusting Low Pressure sensor) was adapted for use with other surfaces sold in long-term and acute care departments in 20 countries (launched in 2014, now termed I-mmersion sensor™). As of the end of 2020, device features made possible by the Group’s research had been incorporated into 20,000 mattress products sold throughout the world by Hillrom for the provision of optimal care to vulnerable patients [ 5.6].

The research has also resulted in a spin out company, Radii Devices Ltd [ 5.7], which adopts cutting-edge engineering to support socket fitting, through the introduction of novel software [ 3.7]. Since March 2019, it has employed three staff members and attracted GBP120,000 of external investment from a University Dragons’ Den event [ 5.8]. The software includes a point-of-care tool for aiding socket design for prosthetic limbs and architecture for storing clinical data to evaluate patient outcomes. This was launched at the Consumer Electronics Show (CES) in Las Vegas, with Worsley as a co-founder. The software platform has already attracted a further GBP208,600 of funding from a leading respiratory mask manufacturer (Philips Sleep and Respiratory Care, USA) to create a complimentary face-mask model, through designing an intelligent and efficient platform to improve their device designs.

Policy impact: changing NHS policy on pressure ulcer reporting and informing new international standards for support surface manufacture

Improving the reporting of device-related skin damage is key to strengthening medical device regulation and optimising product design. The Skin Health Group has been ‘ at the forefront of lobbying activities aimed at improving the reporting of device related pressure ulcers’ [ 5.9]. Based on insights accumulated through the body of underpinning research, the Group worked with NHS Improvement to successfully change reporting policy in England to include device-related damage, marking the first time that device-related pressure ulcers could be documented by clinicians [ 5.9]. This reporting metric was implemented in April 2019 when it was incorporated into Pressure ulcers: revised definition and measurement framework [ 5.9]. It is now part of routine reporting practice in over 200 care facilities across acute, community and mental health services. The Group also worked with NHS Improvement to co-create educational videos for clinicians to support best practice for medical device selection and application [ 5.9]. Coordinated as part of the NHS Stop the Pressure campaign, the videos were viewed 3,000 times within a month of release in April 2020.

The Group have applied their evaluative research methods to work with the British Healthcare Trades Association (BHTA) and the International Organization for Standardisation (ISO) on the development of new standards for two sectors specialising in pressure ulcer prevention: seating and support surfaces [ 5.10]. They have been invited by the BHTA to disseminate their scientific evidence at support surface meetings and international symposiums in London and Las Vegas aimed at educating manufacturers on the need to improve device design. This ‘ has resulted in the collation of extensive data to create a better understanding of the issues of support surfaces and their interactions with human skin’ [ 5.10]. The Group has provided underpinning knowledge to international definitions, published by ISO ( ISO 21856 B.23: Forces on soft tissues of the human body, July 2019) to aid the design of a new standard [ 5.10]. This has created the means to establish standard test methods to evaluate the relative performance of support surfaces, adopted within an ISO framework (ISO/TC 173/WG 11) for which the Group is a participating member of the related ISO committee [ 5.10].

The outcomes from the Francis Inquiry brought serious concerns around nursing in the NHS to the attention of policymakers, the health profession and the wider public. Findings from Southampton research informed and shaped: the ensuing public debate around safe staffing for the duration of the impact period; sustained campaigns for legislative change run by advocacy groups; subsequent developments in ‘safe-staffing’ clinical guidelines and legislation in the UK and beyond. The International Council of Nurses’ CEO commented: “ The Southampton team has made an essential contribution to establishing that safe nurse staffing saves lives. As that recognition has influenced policies to protect and enhance nurse staffing in many countries around the globe, their research has contributed to reducing unnecessary suffering and deaths in hospitals [ 5.1].”

Influencing public policy debates over safe staffing levels for nurses

Coming just months after the Francis Inquiry, our findings on missed care and nurse staffing levels [ 3.2] – in particular that 86% of nurses left necessary care undone, and that this was related to RN staffing levels – caused a public outcry. Having been on the front page of The Times and on BBC Radio 4’s Today Programme and cited in a public meeting by Sir Robert Francis QC two days before the beginning of the REF impact period, the findings continued to stimulate intense debate for weeks and months afterwards through national newspapers, radio and television [ 5.2]. Altmetric data shows that paper 3.2 was still being cited in news articles in 2015, 2017 and 2019 and has reached ‘an upper bound of’ 2.46 million people via sustained Twitter mentions [ 5.2]. The findings linking nurse staffing levels and mortality, published in The Lancet in February 2014 [ 3.1], received worldwide media attention, reflected in an Altmetric online attention score which puts it in the top 0.01% of all rated outputs. It was covered in 33 news outlets, with several direct references still being made by international media between 2018 and 2020; it has reached an upper bound of 7.2 million people via Twitter [ 5.2]. The subsequent studies also received significant coverage and prompted continuing debate. For example, paper 3.5 was covered by 56 international news outlets between 2016 and 2020, reaching an upper bound of 4.16 million people via Twitter [ 5.2].

This widespread and sustained public debate contributed to a change in discourse among policymakers and health practitioners; it provided evidence that shaped the demand for ‘safe staffing’, triggering a shift towards considering nurse staffing as a critical system-level factor. The Safe Staffing Alliance, supported by organisations like Royal College of Nursing (RCN) and UNISON, has campaigned throughout the impact period for a legal minimum RN:patient ratio of 1:8, based on our findings. In January 2014 Andrew George MP secured a House of Commons debate with health minister Dr Daniel Poulter MP on the staffing of acute hospital wards, with a particular focus on RN staffing levels. In it he backed the Safe Staffing Alliance’s campaign and cited our research [ 3.2], saying: ‘ The RN4Cast survey of 32 English hospitals, including more than 400 wards, showed that 43% had registered a nurse staffing ratio of more than 1:8 [ 5.3].’ Evidence from the Southampton studies has underpinned a long-running policy campaign by the RCN for legislation for safe staffing in all parts of the UK; the research was cited on multiple occasions in four major policy reports published by RCN between 2017 and 2019 [ 5.4].

RCN’s CEO wrote that the research ‘ had a direct effect on generating policy and influencing national decision makers across the UK … shining a light on previously unknown linkages between insufficient nurse staffing levels and the impact this has upon patient care … This will undoubtedly be an important contribution towards securing legislation (in England specifically – legislation was passed in Scotland and Wales as detailed below) and ultimately safe and effective care for patients in all parts of the UK [ 5.5] *.*’ A founding member of the Safe Staffing Alliance and clinical advisor to the NIHR Dissemination Centre wrote: ‘ Professor Griffiths and Professor Ball’s research has been highly visible and influenced the way in which nurse staffing has been considered both by policy makers and service providers, providing an evidence base to counter the view that the problems were purely due to a compassion deficit amongst individual nurses [ 5.6].’

Shaping new polices, clinical guidelines and legislation on safe staffing in the UK

Southampton researchers were commissioned by NICE to undertake the evidence reviews for guidance on safe staffing in adult inpatient wards and accident & emergency departments [ 3.3]. Little research had been conducted in the UK so Southampton research on missed care [ 3.2] was important to enable NICE to identify a specific ‘warning level’ for nurse staffing on NHS acute wards. Reflecting a key finding from our research, the final NICE guideline Safe staffing for nursing in adult inpatient wards in acute hospitals, published in July 2014 [ 5.7], recommended (para 1.5.3): ‘ Take into account that there is evidence of increased risk of harm associated with a registered nurse caring for more than 8 patients during the day shifts.’ It said that if RNs on a particular ward were caring for more than eight patients, the senior management and nursing managers should monitor nursing red flag events, perform early analysis of safe nursing indicator results and, if necessary, take action to ensure staffing is adequate to meet patients’ needs. It concluded: ‘ In many cases, patients’ nursing needs, as determined by implementing the recommendations in this guideline, will require registered nurses to care for fewer than 8 patients.’ The commissioned evidence review co-authored by Griffiths, Ball and Jones was published with the guideline.

Griffiths and Jones co-authored an evidence review [ 5.8] for the planned NICE guideline: Safe Staffing for Nursing in Accident and Emergency Departments and Griffiths was invited to join the NICE guideline development group for the safe staffing programme. After responsibility for this work passed to NHS Improvement in 2015 Griffiths and Ball joined the working groups convened to develop further guidance for acute and community care settings. NIHR’s clinical advisor [ 5.6] wrote: ‘ Whilst [NICE] were unable to make recommendations following their review, the clarity of the Southampton evidence led the National Quality Board to publish expectations for nursing and midwifery staffing to help NHS provider boards make local decisions that will deliver high-quality care…In my role as a non-Executive Director at Basildon and Thurrock University Hospitals NHS FT, I was able to see first-hand how Professor Ball and Professor Griffiths’ work was used by the Director of Nursing to support Board discussions on setting staffing establishments.’

Southampton research [ 3.3, 3.4], including the 1:8 ‘warning level’, was cited on multiple occasions in three key ‘improvement guides’ published by NHS Improvement between 2016 and 2019 to ensure safe staffing levels [ 5.9]; Griffiths acted as scientific advisor to NHS Improvement’s ‘Safe & Sustainable Staffing’ panel. Describing Southampton evidence as ‘ significant in shaping these resources’, the Deputy Chief Nursing Officer wrote [ 5.10]: ‘ Professor Griffiths and Ball’s work has been highly influential internationally and nationally here in the NHS. Working with NHS Improvement, Professors Ball and Griffiths have been working to help define and shape policy in relation to the workforce of the NHS. Their work has significantly shaped the knowledge base of nursing work and safe staffing.’

While the UK Government, within the wider political context of austerity and NHS budget constraints, has resisted calls for legislation on safe staffing, the Welsh and Scottish Governments have implemented legislation to set statutory staffing levels, informed by Southampton’s evidence and in response to public concerns and debate to which Southampton research has contributed. The Safe Nurse Staffing Levels (Wales) Bill was proposed by Kirsty Williams MS (Member of Senedd) in December 2014 and she cited 3.1 as key evidence to support the Bill [ 5.11]. In Feb 2015, Griffiths was invited to present evidence to the Welsh Senedd during the Bill process (he cited findings from 3.1 and 3.2 to do so) and Age Cymru and BMA Wales also cited 3.1 [ 5.11]. The bill passed in 2016. The research [ 3.1] was cited in the Scottish Government’s Nursing 2030 vision, published in 2017. In October 2017, in the Scottish Parliament [ 5.12], Miles Briggs MSP asked First Minister Nicola Sturgeon for her government’s response to the concerns raised around nurse staffing levels by the RCN in its report Safe and Effective Staffing: Nursing Against the Odds. This report [ 5.4] was based in large part on Southampton evidence, citing 3.1, 3.2, 3.4 and 3.6. In response, the First Minister said: ‘ *The RCN has called for safe-staffing legislation, and we intend, as we set out in the programme for government, to take that forward.*’ [ 5.12] Legislation to support staffing across health and social care services was passed by the Scottish Parliament in May 2019.

NIHR commissioned Ball and Griffiths to carry out a two-year evaluation of the implementation of national safe staffing guidance in England following the Francis Inquiry. The outcomes, published in 2019, provide an indication of the impact of the policy and guideline changes in England [ 5.13]. They found that RN staffing numbers had increased nationally by 6.4% between 2013 and 2017; 74% of Directors of Nursing said overall staffing levels had improved and two-thirds reported NICE guidelines had been helpful in achieving safe staffing in their hospitals. Based on data from one NHS hospital, they estimated that since 2013 there was a 16% reduction in days staffed with more than 8 patients per RN. If such a decrease in low staffing was extrapolated across all English acute hospitals this would be associated with approximately 1,760 fewer deaths per year [ 5.13].

Shaping new polices and clinical guidelines on safe staffing beyond the UK

Southampton’s finding that important omissions in care were associated with low staffing has led to its use by the Irish Government as an indicator of staffing insufficiency; ‘Care Left Undone Events’ (CLUES) have been adopted in Ireland as part of a new approach to safe staffing [ 5.14]. Writing that the impact of the research on the ‘ development, testing and implementation [of a new framework] cannot be underestimated’, the Deputy Chief Nursing Officer for Ireland stated: “ [Southampton’s] published evidence on care left undone/missed care has provided an important outcome indicator, capable of measurement at ward level, and incorporation into Government Policy for system-wide implementation [ 5.14].’ Ball and Griffiths were contacted directly and asked for advice on how the measure used in their research could be adapted for this purpose.

Globally, the research continues to raise awareness of the need for ‘safer staffing’ and prompt action to change policy and practice. It is routinely cited in authoritative reports [ 5.15] including the WHO’s European Strategic directions: strengthening nursing and midwifery towards Health 2020 goals [cites 3.1] and State of the World’s Nursing 2020 [cites 3.1, 3.3, 3.5], and the International Council of Nurses’ formal response to the WHO’s Global Strategy on Human Resources for Health: Workforce 2030. Paper 3.1 was cited by Australia’s Department of Health in its 2019 report Educating the nurse of the future, while 3.1 and 3.5 were referenced by the Australian Nursing and Midwifery Federation (Tasmanian Branch) and the Queensland Nurses & Midwives’ Union to support their calls for higher ratios of nurses to patients. The evidence was cited by the American Nurses Association (2015) report Optimal Nurse Staffing to Improve Quality of Care and Patient Outcomes and the Belgian Health Care Knowledge Centre (broadly equivalent to NICE), whose 2020 report Safe Nurse Staffing Levels In Acute Hospitals cites 3.1, 3.2, 3.3 and 3.5. [ 5.15]

University of Southampton research designed to improve quality of life for people with incontinence has benefitted: a) patients, by increasing user confidence in and access to a wider and more sustainable range of continence products and devices, b) clinicians, supporting their practice through evidence-based online guidance, professional development training and the availability of new devices on prescription, and c) policymakers, through the development of new international standards and WHO product specifications that strengthen regulation of clinical devices and widen access to quality, cost-effective products in low-income countries.

Increased confidence in product choice and wider access to products for users, their informal carers and clinicians

We pitched the concept of the Continence Product Advisor website to the International Continence Society, the foremost, international, multi-disciplinary organisation for incontinence education and research (3000+ members worldwide), who invested in the technical expertise to build and launch the website in November 2013. This website is the first evidence-based, comprehensive and independent (i.e. not industry-driven), multimedia resource for patients and clinicians, utilising our research [ 3.1-3.3,3.5] to support continence product selection and use. It is the only evidence-based source of continence product advice listed on the NHS website for patients, with more than 1 million visits from men and women from more than 190 countries worldwide over the impact period. It averages more than 10,000 visitors per month. More than 890 product queries and 240 user tips have been submitted by users, informal carers and clinicians, each answered by an expert nurse [ 5.1]. The website is maintained by the International Continence Society and it is a valued resource for its international membership and their patients. Its former Secretary General states: “ The value of the website is inestimable … I find the website incredibly helpful to guide both patients and caregivers in the selection of appropriate products.” [ 5.2] Online surveys show that most users found the website ‘very helpful’ (74%), gaining confidence in product selection and use (66%) [ 5.3]. Representative feedback included: “ It is … very informative, helped me realise there are many more options to manage incontinence than I thought” and for men preparing for surgery, “Forewarned is forearmed … takes away some of the fear … helps you to deal with your situation more easily and confidently”.

The Continence Product Advisor is the core component of a new education programme (MOOC) Understanding Continence Promotion [ 5.4], launched in February 2019 by the UK Association for Continence Advice (ACA), a membership organisation for all health and care professionals, including NHS Trust continence service leads, with an interest in bladder and bowel health. The course, which offers training on how to support self-management of continence conditions, is free to ACA members and can count as a professional development credit – although informal carers and people living with incontinence have also completed it. It has been run six times over the REF impact period, training 3622 people from 119 countries; 100% of responders to a post-course survey reported gaining knowledge or skills and online reviews posted on the FutureLearn site gave an average rating of 4.7 out of 5.0. [ 5.4]

Representative feedback included: “ I think it would great if all nurses could have this introduction to what continence means, the effects it has on individuals … made me reflect on my current practice” (Nurse of 12 years). “ Made me feel like taking up nursing again” (Informal carer). “ It has enlightened me on how to treat and take care of my bowel and if there’s incontinence occurrence how to control and treat it” (Person living with incontinence). [ 5.4] Professor Jo Booth, MOOC Lead stated: “ *Without access to this unique resource (Continence Product Advisor) we would have had great difficulty in delivering the comprehensive, independent information our students need.*” [ 5.5]

New international standards to improve product quality, strengthen device regulation and increase access to cost-effective, reliable continence products in low-income countries

As a result of her role in Management with Continence Products [ 3.4] and the clinical trials [ 3.1-3.3], in 2016 Fader was invited by the International Continence Society to lead an international group of experts to develop standardised terminology for absorbent products [ 5.6]. Absorbent incontinence products come in a wide range of different designs, but the variety of synonyms used to describe them are confusing for product users, clinicians, manufacturers and purchasing agencies. A new standard was needed to better reflect current product design and aid decision-making. The outcome of the work was a new recommended terminology for all designs of single use absorbent products [ 5.7]. Fader’s research influenced the International Organization for Standardization (ISO) when the ICS terms were adopted by ISO. Jesper Nordlinder, ISO Aids for Ostomy and Continence Committee Lead stated: “ ISO standards are highly influential documents which are used worldwide by industry (manufacturers of the products specified) and key institutions involved in the procurement of products including the UK Supply Chain … Professor Fader’s research [has] provided her with unique expertise on the use of a wide range of products, both from a clinical and academic standpoint. Therefore, as a consequence of the close working between the two committees, her expertise influenced the ISO terminology.” [ 5.8].

Fader was subsequently invited by the WHO in 2016 to develop assistive product specifications (APS) for disposable and washable absorbent continence products [ 5.9] which utilised the new standards. The WHO Global Cooperation on Assistive Technology (GATE) had launched the Priority Assistive Products List, selected on the basis of widespread need and impact on people’s lives. APSs underpin the priority assistive product lists and provide a set of standards that regulate the procurement of absorbent continence products in low-income countries. They are used by government procurement officers to guide tendering processes and inform the UNICEF catalogue. In Tajikistan for example, absorbent pads have been highlighted as the fifth most needed assistive product group. The APS developed by Fader et al was adopted onto Tajikistan’s new assistive products list in 2019 [ 5.10]; this enabled procurement agencies in Tajikistan, for the first time, to purchase clinically effective, sustainable and cost-effective continence products. Describing the UoS research contribution as ‘ essential’, WHO’s GATE lead said: “ The inclusion of the specifications for absorbent continence products, developed by Professor Fader, is an important advancement for the millions of people managing incontinence with limited access to essential products.” [ 5.9] This has recently led to Fader and Murphy being commissioned by WHO to research the provision and use of washable absorbents in low income countries (GBP60,000).

Provision of sustainable, reusable and effective options for intermittent catheter users

Fader has highlighted the shortcomings of catheter design and the need for innovation in design and methods for use in various media interviews, including live appearances on BBC Breakfast and Radio 4 Today in 2015. The UoS group subsequently worked with a company developing a biodegradable, reusable intermittent catheter in order to reduce the use of single use plastics. The UoS MultiCath Milton cleaning method [ 3.7] was essential in enabling the first reusable and biodegradable intermittent catheter, Emteva^TM (Hunter Urology), to become CE marked for sale in the EU and available for patients via the UK drug tariff. Prior to Emteva, the estimated 20,000+ female intermittent catheter users in the UK alone were confined to single use catheters. The availability of a reusable intermittent catheter to use alongside single use ones has been reported by catheter users to provide optimal choice for their physical and lifestyle needs. The CEO of Hunter Urology stated: “ *The work done by Professor Fader’s team at the University of Southampton has been essential in enabling the reusable Emteva catheter to become available to catheter users.*” [ 5.11]. Around 36,000 Emteva catheters have been prescribed in England alone since 2016 benefitting approximately 9,000 women [ 5.12]; they are also sold internationally, including in Denmark and Australia [ 5.11]. The estimated annual cost per user for single-use intermittent catheters is GBP2,190 (based on typical usage of 4 catheters per day at a mean intermittent catheter cost of GBP1.50). If one Emteva is substituted for all daily catheterisations, this equates to an annual saving for all female intermittent catheter users in the UK of more than GBP32,000,000 and a 100% reduction in plastic catheters being thrown away.

Based on the findings in 3.7, Wilks was awarded a Small Business Research Initiative grant (GBP530,000; NIHR) to develop and test a biodegradable, biocidal, impregnated wipe to offer a quick, discreet alternative or complementary cleaning method to Milton. This was designed to further increase the uptake of reusable intermittent catheters. A partnership with JVS Products Ltd developed a biocidal wipe that was shown to be effective at cleaning reusable catheters ‘on the go’. Having achieved its Class I CE mark in 2020, JVS temporarily pivoted the product towards the surface cleaning market in response to the Covid-19 pandemic, achieving more than 150,000 in sales up to December 31, 2020 [ 5.13].

Improved options for safe penile compression device use and development of the ‘Southampton clamp’

Having identified through their research [ 3.3] a need among men for an effective, reusable clamp to enable physical activity and reduce reliance on disposable, plastic-backed pads, the UoS group, together with clamp users, co-designed a new clamp that is more effective, more comfortable/less painful and easier to use than existing designs. The ‘Southampton clamp’ [ 5.14] provides a reusable (and therefore sustainable), discreet and secure way of preventing leakage after prostatectomy. A preliminary user trial showed that men felt the design is discrete and looks good, and is easy to put on and take off, compared with the best of the currently available clamps. A new industry partner will support prototype development, licensing (CE marking) and commercialisation of the clamp (and other newly developed products) via internet sales and the Drug Tariff [ 5.15]. Currently manufacturers’ guidance provided with several clamp brands is not based on evidence, which places users at risk of pressure-related skin damage. Working with clamp users, UoS research also enabled the development and publication of evidence-based generic clamp guidance on the Continence Product Advisor.

**Embedding Diagnostic Ultrasound Imaging (DUSI) in Podiatry – Bowen, Cherry, Gates

Since Bowen (2008) first highlighted that podiatrists could use DUSI reliably, the technique has been widely adopted by those working within the fields of foot and ankle musculoskeletal medicine. International interdisciplinary research with New Zealand collaborators has documented that the use of DUSI by podiatrists has been expanding globally over 2012 – 2020 [ 5.1, 5.2]. Of 239 podiatrists who completed the survey and were regular users of DUSI, the majority were in Europe (UK 37%, Spain 31%, Netherlands 12%; Malta 1%; Italy 1%; Ireland 0.5%) with others from Canada (13%), Australia (4%), South Africa (0.5%), USA (0.5%) and Kenya (0.5%) [ 5.1]. The common cited benefit of using DUSI was “improved access, reduced waiting times for appointments, and improved patient journeys through tighter, focussed management plans” [ 5.1].

An exemplar of impact on patient care pathways is a new local Podiatry-led DUSI clinic within Solent NHS Trust primary care service (2016-present). Directly shaped by the Southampton DUSI research alongside provision of practical, face-to-face DUSI training of podiatrists (n=6), this has reduced the length of care pathway from 42 to 9 weeks, and clinician encounters from 6 to 2 [ 5.3].

As a direct result of the Southampton team’s research, foot and ankle DUSI is included as a key component in national guidelines (UK North West Clinical Effectiveness Group and UK Podiatry Rheumatic Care Association, 2011; 2014; 2021 in prep) aimed at the management of foot health in rheumatoid arthritis and improving prognosis through early detection [ 5.4]. The guidelines continue to guide practice of the UK College of Podiatry (CoP)’s 13,000 members UK wide (NHS and independent practice) with around 350 Podiatry graduates annually. The lead author of the guidelines states, “the guidelines are a major document used in the undergraduate and postgraduate education of podiatrists and hence enhancing the patient experience and outcome of foot health management” [ 5.4]. Similarly, in 2017, the team led the ratification of the CoP in becoming one of six member organisations of the Consortium for the Accreditation of Sonographic Education (CASE) – a key award ensuring the legitimisation through accreditation of training programmes that develop podiatrists as safe and competent DUSI practitioners. Bowen, as Chair of the CoP Research and Development Committee, founded the CoP Special Advisory Group for DUSI with clinical researchers Dr Lindsey Cherry and Dr Charlotte Dando.

Southampton’s research team continue to drive national and international initiatives to ensure the research directly informs podiatric training (pre and post-registration) and clinical practice. For example, the introduction of DUSI workshops in Malta “has translated into circa N=70 graduate podiatrists over 10 years increasing their understanding of the use and relevance of DUSI towards improvements in the diagnosis and timely management of foot and ankle musculoskeletal problems in Malta” [ 5.5]. In addition, Bowen gave invited keynote presentations in Singapore and Australia [ 5.6], as well as the UK, and became adjunct professor for Auckland University of Technology (AUT), NZ and Queensland University of Technology to support their DUSI research capacity building. Regarding the Osteoarthritis Research Society International (OARSI) Foot and Ankle Research Group led by Bowen, AUT New Zealand Professor Keith Rome stated: “the recently formed OARSI foot and ankle research group will allow future collaboration between the two institutes relating to DUSI and in other inflammatory arthropathies such as systemic lupus erythematous and psoriatic arthritis” [ 5.2].

**Driving Ultrasound Imaging in Physiotherapy – Stokes, Warner, Worsley

Findings from University of Southampton research have led to the translation and global take-up of USI techniques in Physiotherapy into other areas, such as diagnostics, guiding rehabilitative and interventional techniques (e.g. guided acupuncture and injections). The work with Space Agencies (ESA, NASA [ G3]), in particular, has raised the profile of USI in Physiotherapy.

The global reach of Southampton’s research impact is best evidenced through Stokes’ leading position in an international consortium of USI Physiotherapy experts [letters of support 5.7- 5.9], who established the field of Rehabilitative USI (RUSI) at the first RUSI Symposium in 2006 (Texas, USA) and whose most recent undertaking was the 2020 international USI survey of physiotherapists [ 3.6]. The 2006 symposium was led by US Army Medical Specialist Colonel Deydre S. Teyhen, who stated in 2020: “In regards to [RUSI], it is clear from the research literature that Dr Stokes’ team initiated this field of study for physical therapists. The investigative team in Southampton has conducted basic research required to validate this technology and been international thought leaders on how to apply this technology” [ 5.7]. The lead author of the 2020 international USI survey, Dr Richard Ellis of AUT, cited [ 3.5] as “ one of the seminal publications for physiotherapy USI”, adding that “th e different applications of USI in Physiotherapy have stemmed from the Rehabilitative Ultrasound Imaging [RUSI] field, which was greatly influenced by research from Southampton.” [ 5.8]

The international USI survey attracted more than 1,300 responses, which indicated a wide scope of practice (in terms of different applications) of USI across the Physiotherapy profession in 50 countries. Applications include diagnosis of musculoskeletal pathology, monitoring healing after muscle trauma, biofeedback to re-educate muscle contraction and guiding needles, e.g. for acupuncture. These uses of USI result in more accurate assessment and more tailored treatment for individual patients, making treatment more effective. The survey illustrated the wide global reach of our research impact, with 60% of respondents being users in Europe, 20% in Australasia and 10% in North America. Within Europe, 47% of UK respondents were users, with higher proportions in the Netherlands (82%) and Spain (69%; where USI is already implemented in pre-registration Physiotherapy training). In Australia, 69% were USI users.

Teyhen further testified to the international reach of Southampton’s research impact, stating that “ in addition to [the UK], Southampton’s work helped advance RUSI for musculoskeletal medicine in the United States, Australia, and other European Countries. Their work in this field advanced physical therapy both in the civilian and military sectors… It is important to note that the gold standard techniques that previously existed were not translatable into a clinical setting. This is why this line of research has had such a huge impact around the world.”

Stokes has driven this adoption through several strands of activity within the REF impact period. She chaired the closing discussion at the second RUSI Symposium in 2016 (Madrid, Spain) to set international clinical, education and research agendas. This led the consortium to author a 2019 International Position Statement [ 5.10], which highlights the impact of USI use in clinical practice: “ faced with the rapid growth of USI use by physical therapists over the last decade, the profession is faced with a situation in which its traditional scope is being challenged to evolve”. The hosts of the Symposium from Acalá University, Madrid stated [ 5.9]: “ a new paradigm shift was reached, thanks to the international consensus”. Ellis asserts that this Position Statement “is evidence of Southampton’s impact that is leading regulation and policy development for physiotherapy USI …” [ 5.8]. The position statement shows how USI protocols developed by the Southampton team are used to monitor changes in muscles due to pathology, disuse and recovery. It also illustrates eloquently how physiotherapists’ use of USI has evolved from Southampton’s research to three distinct clinical applications: 1) diagnostic; 2) rehabilitative (RUSI; assessment and biofeedback tool to aid recovery); and 3) interventional (e.g. guided acupuncture needles and injections) [ 5.10].

These advances have translated directly to novel applications that have changed practice, and in 2018 Stokes and Warner were funded by the UK Space Agency on an international collaborative ESA-funded project (Muscle Tone in Space; Myotones Project) to monitor ESA and NASA astronauts’ muscles during 6-months on the International Space Station (ISS), at a full economic cost of £50m. The head physiotherapist at ESA says: “I use USl to assess muscle size and contraction in astronauts after a long-term stay in microgravity” to aid their recovery [ 5.11]. This work with deconditioned astronauts also provides insight into mitigating the deconditioning effects of aging on muscles, as well as rehabilitation after periods of inactivity. Embedding USI protocols for testing muscles aided validation of Myoton muscle measurement technology (MyotonPRO, a non-invasive hand-held device that measures tone of superficial muscles) and thus enabled its early adoption on the ISS. Science Minister Sam Gyimah said: " This pioneering space project … a great example of how we are backing science and the space sector through our modern Industrial Strategy and how, through our Ageing Society Grand Challenge, we are harnessing the power of innovation to help meet the needs of an ageing society." [ 5.12]. Dr Libby Jackson of the UK Space Agency (UKSA) said the UKSA “supports ground breaking experiments, like this one at the University of Southampton, to monitor the muscle health of astronauts … as part of our commitment to ensure Britain is a leader in space-based scientific research and innovation.” [ 5.12]. In July 2018 an astronaut (>1.3 million followers) tweeted and stressed in a video the importance of monitoring musculoskeletal health in space [ 5.13].

The Covid-19 pandemic required the Southampton scientists to teach and guide NASA USI specialists (novices to muscle imaging) remotely to image muscles, providing lessons for virtual guided imaging on Earth between specialist medical centres and remote clinics [ 5.14]. The Southampton course for physiotherapists was the first to be endorsed by a medical imaging body (British Medical Ultrasound Society, 2004). Teyhen states: “Southampton’s evidence-based educational courses on this topic helped ensure the highest level of science, quality, and safety were integrated into the clinical application...” [ 5.7] . Other courses informed by Southampton’s research have evolved, several by University of Southampton alumni, course attendees and research collaborators worldwide, including the UK (John Leddy), Canada (Jackie Whittaker), Australia (Julie Hides) Ireland, (Cliona O’Sullivan) and Spain (Samuel Fernández-Carnero). In Spain, the number of courses delivered across Universities and Hospitals in 2020 “ has reached 3-4 courses each weekend… recognition came from the Community of Madrid Sanitary Counsel, which approved the education and purchase of ultrasound units for Physiotherapists in Public Health Hospitals [ 5.9] ”.

The contribution of Southampton’s extensive impact on the uptake of USI was reflected in Stokes’ award of an OBE in 2018 for ‘ Services to Physiotherapy Research’.

Changing policy approaches towards personalised care for people with cancer

Having shaped the UK National Cancer Survivorship Initiative, a flagship programme led by the Department of Health and Macmillan Cancer Support to improve support for people recovering from cancer, the Macmillan Listening Study went on to be influential in the Movember Foundation’s decision to commit $28m to improving the lives of prostate cancer survivors. The global TrueNTH programme (2014-2017), chaired by Corner, reflected a wider policy shift in the UK and internationally to personalised cancer care that is cost-effective and responsive to patient need. CREW also provided important evidence to inform this agenda. The findings were instrumental in shaping the strategic direction of the Wessex Cancer Alliance’s new personalised care agenda, as set out in its five-year plan launched in February 2020. This informed service delivery across seven hospitals serving a population of 2.8 million [ 5.1].

CREW significantly contributed to UK prehabilitation guidance for people with cancer published by Macmillan, NIHR and the Royal College of Anaesthetists in July 2019 [ 5.2]. CREW informed the guidelines’ key principles, specifically the impact of poor mental health and self-efficacy on patient health and wellbeing. The guidance has been widely accessed, with clinical practitioners and trusts using the guidance to justify prehabilitation service business cases. Dr Chloe Grimmett was an invited member of the Psychology expert working group for the guidance. CREW informed quality standards for developing, implementing and measuring self-management support in Ontario, Canada ( Self-management in cancer, November 2018) [ 5.3]; Foster was the only invited expert outside Canada on the steering committee.

PTFU and TrueNTH UK have contributed significantly to national policy on supported self-managed follow-up. With more than 47,000 new cases of prostate cancer in the UK each year (Cancer Research UK), adoption of the TrueNTH UK care model from 2015 has significantly impacted on service configuration, potentially saving over £1.8m a year nationally (based on £39 saving per patient). PTFU and TrueNTH UK were highlighted by NHS England (NHSE) as models of good clinical practice for meeting the objectives of its 2015-20 strategy: Achieving World-Class Cancer Outcomes [ 5.4; 5.5]. The NHSE lead for Living With and Beyond Cancer stated in 2018: ‘ TrueNTH research has made significant contribution to the evidence base that underpins the implementation of stratified follow up nationally… The insights from the research will influence NHSE’s revision of Innovation to Implementation’ [ 5.5]. This guidance was published in March 2020 with a prominent citation of the cost-effectiveness of PTFU and TrueNTH UK [ 5.6].

TrueNTH UK findings informed new recommendations in the updated NICE guideline Prostate cancer: diagnosis and management, published in May 2019. Specifically, they resulted in the timeframe for initiating supported self-management to be revised from two years to six months (Rec. 1.3.46) [ 5.7]. In January 2020, TrueNTH UK was highlighted by NHS Digital as an important model for improving the experiences and outcomes of men with prostate cancer [ 5.8]. TrueNTH UK and CREW evidence have informed nursing workforce planning throughout England, in particular the creation of new Band 4 Cancer Support Worker (CSW) roles within nursing teams. Health Education England (HEE) said TrueNTH UK ‘ generated significant insight into the workforce required to deliver cancer follow-up – particularly in relation to the introduction of the new band 4 support worker role’, using it as a case study of best practice in its own stakeholder engagement [ 5.9]. The finding that CSWs had made a ‘ significant contribution to cancer-related supportive care’ was cited in the Wessex Cancer Alliance’s five-year plan and led directly to the creation of 11 permanent CSW posts within nursing teams for colorectal, upper gastrointestinal and other tumour groups at University Hospital Southampton (UHS) NHS Foundation Trust [ 5.1].

Changing health service delivery for the benefit of people affected by cancer

CREW evidence has informed models of care that are stratified according to timely assessment of patient-identified need and confidence to self-manage. Macmillan Cancer Support and NHSE are committed to incorporating assessments of confidence to self-manage into updated Holistic Needs Assessments, a key component of The Recovery Package – a recognised set of interventions for improving the lives of cancer patients [ 5.10]. CREW evidence has been used by HEE and Macmillan Cancer Support to develop and deliver core competencies and learning requirements for Allied Health Professionals, nurses and the wider workforce in the UK [ 5.10]. Since April 2020, CREW participant data have been used by Macmillan and the Wessex Cancer Alliance to understand the impact of COVID-19, informing strategic responses to the pandemic. Macmillan commented that senior leadership, strategy and planning teams had used CREW ‘ to gain an understanding of the likely impact of COVID-19 at a time where few data were available. Knowing how many live alone, look after others, receive practical support from others outside the home, have access to the internet, and the proportions of people affected by cancer living with comorbidities was essential for our development of guidance and support’ [ 5.10].

As a result of the PTFU study, UHS introduced needs assessments into the clinical pathway from diagnosis to tailor support during treatment, with better access to the nursing team and support workers. Throughout the impact period, this has benefitted an estimated 80% of breast, 95% of testicular and 50% of colorectal cancer survivors in Southampton (where 67,500 new cases are diagnosed each year) [ 5.4]. Adopted by UHS in August 2014, the Trust has since extended this to include people with lymphoma, endometrial and prostate cancer (more than 60% of men with prostate cancer have received supported self-management) [ 5.4] .

TrueNTH UK’s supported self-management model [TrueNTH UK], a finalist in the Health Service Journal (HSJ) Awards in 2017, was adopted in all five study sites by Spring 2015: UHS, Royal United Hospitals Bath, Royal Cornwall Hospital, Dartford and Gravesham and St Helens and Knowsley Teaching Hospitals Trusts. Prostate Cancer UK presented TrueNTH UK findings at eight NHS webinars and events in 2017/18, encouraging wider adoption of the care model [ 5.11] . By 31^st December 2020, 38 NHS trusts in England (25%) had adopted TrueNTH UK, with a further 10 trusts planning to do so in 2021 [ 5.12]. Nearly 11,200 men with prostate cancer had been supported by TrueNTH UK by 31^st December 2020, and 6,900 people with breast, colorectal, haemotological or gynaecological cancers had accessed the care pathway following wider replication [ 5.12]. TrueNTH UK informed recommendations for managing prostate cancer in the Welsh Planning Framework, 2019-22 [ 5.13]. In June 2019, the Welsh Government mandated implementing the model in all 14 Welsh urology departments [ 5.11, 5.13], serving more than 8,000 men with prostate cancer, affecting the care of around 5,300 men, and freeing up around 8,000 outpatient appointments per year. A Scottish cancer network is committed to implementing TrueNTH across its four Health Boards [ 5.11]. In eight hospital trusts in the Cheshire and Merseyside Cancer Alliance, more than 5,500 people with breast, colorectal and prostate cancer used the pathway between May 2015 – November 2019, saving 38,000 outpatient appointments [ 5.14] . A toolkit was produced by the TrueNTH UK team to provide an NHS guide for implementing the model and supporting service change across UK cancer centres. The toolkit was accessed by all NHS centres providing uro-oncology services in England (N=138) and Wales (N=14), and 10 centres in Scotland, Northern Ireland and the Republic of Ireland [ 5.12]. As an indication of the significance of these service changes, use of the TrueNTH UK model saves approximately 1.5 appointments per patient per year, potentially saving £14.3 million a year in the UK if all newly diagnosed patients accessed the model.

The online portal MyMedicalRecord (MyMR), co-developed by UoS and UHS for TrueNTH UK to provide online remote access to test results, is used across breast, colorectal, testicular, lymphoma, prostate and endometrial cancers at UHS [ 5.12]. The portal was winner of an HSJ technology award in 2016 with TrueNTH forming a major part of the evidence presented. There has been wide uptake of MyMR: by 31^st December 2020, it was supporting remote surveillance of men with localised prostate cancer in 38 NHS trusts in England [ 5.12]. In August 2020, Hampshire Hospitals Trust began using the platform to manage patients with mild COVID-19 symptoms from home. In June 2020, UHS was named as a supplier on the Crown Commercial Service’s Spark Dynamic Purchasing System Framework, which gives NHS trusts easier access to the MyMR platform.

Improving patient outcomes through service change and better access to information

In 2017, NHSE published a case study highlighting how Southampton’s PTFU approach had benefitted patients [ 5.4]; this provides an indication of the wider patient benefit delivered through policy and practice changes described earlier in this section. In it, UHS’ Head of Cancer Nursing wrote: ‘ Not having to constantly come back to hospital for unnecessary check-ups is a first step to recovery and independence. The second is to make sure that any ongoing symptoms are managed well and the patient understands the signs of potential recurrence so that they can be assessed only as necessary. Our Patient Triggered Follow Up service does both of these things, putting the patient firmly in control of how they manage their recovery’ [ 5.4].

69% of men participating in TrueNTH UK agreed / strongly agreed that they felt reassured under the Programme, valuing the ease of contacting clinical teams, having quick access to results, not having to attend hospital, and the reassurance of talking to others at the workshop. Other patient benefits reported in Cheshire and Merseyside Cancer Alliance’s adoption of the model (January 2020) include: tailored treatment plans, increased self-care skills and reduced expenses [ 5.14] . One CSW said that ‘ patients find it easy to navigate, very accessible and are so relieved they have so much more time freed up by not having to attend in-person follow-ups’ [ 5.14]. In 2016, Dr John McGrane, Oncology Consultant, Royal Cornwall Hospital Trust [RCHT], reiterated the patient benefit: ‘ We see around 400 new patients a year at RCHT with prostate cancer, which has increased around 25% in five years. Our clinics were becoming overwhelmed, with some patients having to travel great distances for follow up clinics that would at times only take about 5 minutes. The TrueNTH project allows well patients to be managed at home, allowing them to have access to their own records and to follow their own progress. It also … helps to free up spaces within our clinics for new patients or for patients who have encountered problems’ [ 5.15].

Macmillan launched RESTORE in October 2019, providing the first free evidence-based digital resource for managing cancer related fatigue for patients and health professionals. The study showed 77% of users had increased confidence to self-manage fatigue after using RESTORE. The resource was promoted to UK health professionals via Macmillan’s Professionals, encouraging them to refer patients to it as part of the Recovery Package [ 5.10]. When promoted on Macmillan’s Facebook channel in October 2019, it attracted 1,300 reactions, 114 comments and 209 shares. It was highlighted online by the Patient Information Forum, Tameside & Glossop NHS Trust, South Warwickshire NHS Trust, North Wales Cancer Patient Forum and Peter MacCallum Cancer Centre, Australia. Nationally, nearly 1000 people registered to use RESTORE within a month of its launch. In February 2020, the Wessex Cancer Alliance cited RESTORE in their five-year plan as an important resource for supported self-management [ 5.1].