Results and submissions : REF 2021

Implementing high quality stratified care for low back pain

Submitting institution: University of Keele
Unit of assessment: 3 - Allied Health Professions, Dentistry, Nursing and Pharmacy
Summary impact type: Health
Is this case study continued from a case study submitted in 2014?: No

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1. Summary of the impact

Back pain accounts for 10% of all years lived with disability. Our ‘risk stratification’ approach for back pain (STarT Back), and its implementation (IMPaCT Back) has led to fundamental changes to policy and patient care nationally and internationally. NICE recommends use of the approach, which links risk of persistent disability (low, medium, high) with matched treatments. Public Health England determined that STarT Back has a Return on Investment (ROI) of up to £226.23 for every pound spent, with estimated annual societal savings of £46 million. STarT Back was selected by Universities UK in the top 100 key UK innovations (2018).

2. Underpinning research

The biopsychosocial model for low back pain has long been recognised, but evidence of how to incorporate this into clinical practice was lacking. As a result, guidelines did not include recommendations relating to management of psychosocial aspects of back pain. We produced ground-breaking research in 2011, published in the Lancet, which demonstrated that stratified primary care management, nested in a biopsychosocial framework, led to significant improvements in clinical outcomes, improvements in health-related quality-of-life, cost savings from reduced health-care use, and fewer back pain-related days-off-work [3.1].

In order to examine whether trial-based findings were applicable to real-life clinical practice, we conducted the IMPaCT Back study to test implementation of the STarT Back approach [3.2]. 922 patients from 64 GPs and linked physiotherapy services were followed-up; 368 identified prior to stratified care implementation, and 554 following implementation. Findings corroborated those from the STarT Back trial, demonstrating that time-off-work halved, and 30% fewer patients received sickness certification. Economic evaluation indicated that the approach led to cost savings of £34 per patient coupled to an improved quality of life, plus savings from reduced work absence (£400 per employed patient) [3.3].

To maximise the benefits of the STarT Back approach, a substantial shift in General Practitioner and Physiotherapy clinical behaviour was required. To understand these perspectives, qualitative research gave vital insights into GP [3.4] and physiotherapists’ [3.5] views of adopting the STarT Back approach. Interviews with thirty-two GPs revealed low levels of interest in low back pain, and a potential lack of engagement with a new treatment approach. This highlighted the support that would be needed for working practices to enhance continued use of the approach outside of trial settings. Thirty-two interviews were conducted with physiotherapists to elicit views of implementing change [3.5]. These revealed the conditions and consequences of change that would aid translation into other settings and highlighted perceived benefits to clinicians and patients. In moving to a new approach, issues such as willingness to change, perceived benefits, and the process of adjustment must be considered.

To examine the longer-term economic benefits of the STarT Back approach, beyond the usual 1-year follow-up, statistical modelling of data from the clinical trial and implementation study was carried out [3.6]. This study demonstrated long-term cost-effectiveness of the approach, delivering 0.14 additional quality-adjusted life years (QALYs) at a cost-saving of £135.19 per patient over a ten-year period. The work showed that the predicted cost-savings and improvements in quality of life were likely, even if healthcare costs were different to the original study, giving further evidence of the generalisability of the findings, and identified that the greatest benefits and cost-savings could be found in high-risk patients.

4. Details of the impact

STarT Back is recommended by NICE and Public Health England. The Return on Investment (ROI) for society is up to £226.23 for every £1 spent, with ~£46 million saved annually. In the past 6 years STarT Back has fundamentally changed policy and patient management nationally and internationally. It has improved quality of life for patients and helped return-to-work. Through its implementation, clinicians now have an evidence-based approach to guide care, supported by bespoke online training (Stevenson).

Transforming Health Care Policy

Policy makers, guideline developers, health purchasers, and public bodies have adopted STarT Back in national and international clinical guidelines (5.1-5.3). For example, for the first time NICE back pain guidance (2016) recommended STarT Back, leading to a steady increase in uptake in primary care (2014-2018) (5.1). Public Health England used health economics analysis in their ROI report (5.4) to support their recommendation for STarT Back throughout England. The report suggested that for every £1 spent on STarT Back, £226.23 is saved at a societal level (5.4). Report findings were used to support transformation of UK Musculoskeletal and Back Pain Pathways (5.5-5.7).

Transforming Services

Services have been redesigned to maximise benefits across the UK and internationally. Following the recent introduction of STarT Back in New Zealand, 21% of surveyed physiotherapists are using the approach (5.8). Across primary care 45% of general practices (specifically AURUM practices - 7 million patients registered at EMIS Web® 2018) had used STarT Back (2014-2018) (5.1). In the West Midlands through the Academic Health Science Network, 15 Clinical Commissioning Groups and 15 Provider Trusts have been engaged in implementing STarT Back, with 2378 patients benefiting (5.7). In East Staffordshire, 226 patients had significant health improvements when using STarT Back (5.9). A NICE Shared Learning Case (5.10) demonstrated greater patient satisfaction and quicker appointments when services were reorganised using STarT Back. In Gloucestershire (5.11), “ patients received significantly more treatment sessions as the risk-rating increased, in line with the anticipated impact of targeted treatment pathways. Physiotherapists were largely positive about using the model. The potential annual impact of rolling out the model across Gloucestershire is a gain in approximately 30 QALYs, a reduction in productivity losses valued at £1.4 million and almost no change to NHS costs.”

Support for Industry

In 2018 STarT Back research was identified in the top 100 impacts (5.12) by Universities UK. If used in half the patients in England, estimated annual savings equate to £46 million. To increase use by GPs in Primary Care, we have developed and implemented successful electronic STarT Back reminders with industry partners (e.g. 5.1) (EMIS Health, TPP, SystemOne). A large NHS Trust in the West Midlands mandated use of the STarT Back reminder system, and analysis of >4000 patient interactions (EMIS) indicated that the tool was completed in 87% of cases. Connect Health took an innovative approach to introduce STarT Back into large commercial Occupational Health settings from 2018, to assist employee return-to-work.

Support for Clinicians

We have changed what clinicians do for patients with back pain. We have trained over 300 national and international physiotherapists to deliver STarT Back (e.g. 5.7, 5.8, 5.9, 5.11). We recently developed online training to support uptake; the website received 17,328 visits on launch day. Currently, 1,499 users have registered for and used STarT Back Online Training, 1,128 attempted the final quiz with 685 successful completions. Overall, the STarT Back website has received 236,407 visits, and the training/resources page 23,021 visits (data extracted 31.12.2020). (5.9) The approach is included in the Royal College of General Practitioners (RCGP)/Versus Arthritis Curriculum (5.9) (Care of People with Musculoskeletal Problems, 2016) https://startback.hfac.keele.ac.uk/clinicians/ and four RCGP modules. To assist international clinicians, the STarT Back tool has been translated into 40 languages; our translation webpage had 1,402 visits and online calculator accessed 14,684 (31.12.2020) (5.9). Our website and online survey show the tool is being used in Europe, Africa, Australia, South Africa, New Zealand, Ireland, Hong Kong and North America (5.9).

Support for Patient information

We have changed the way information for patients with low back pain is created and shared. Keele’s LINK Group (Lay Involvement in Knowledge Mobilisation) co-produced an evidence-based patient leaflet (5.9). Underpinned by STarT Back research, this has been endorsed by NICE (E208); received a British Medical Association Commendation Award; been shared with colleagues in Australia, Ireland, Malaysia, New Zealand and downloaded 9,679 times (extracted 24.9.2020). Our innovative STarT Back animation has had over 1,800 Twitter views and 4,126 on YouTube. Patients are enhancing implementation across in Staffordshire as key members of a Community of Practice to embed STarT Back.

In summary, STarT Back implementation has fundamentally changed policy and patient management nationally and internationally, with substantial cost effectiveness and returns on investment.

Improving outcomes for people on peritoneal dialysis

Submitting institution: University of Keele
Unit of assessment: 3 - Allied Health Professions, Dentistry, Nursing and Pharmacy
Summary impact type: Health
Is this case study continued from a case study submitted in 2014?: No

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1. Summary of the impact

Peritoneal Dialysis is used to treat 380,000 people with kidney failure nationally and internationally. Our research has contributed to sustained improvement in their survival in the US and Europe, almost double that seen for in-centre haemodialysis treatment. We have identified two types of peritoneal membrane injury which require different approaches to improve fluid management, while avoiding excessive harmful exposure from glucose in dialysis fluids. This has informed international guidelines for membrane assessment and improved prescription of peritoneal dialysis, including optimal time on treatment. Our findings have also indirectly contributed to increased global demand for non-glucose fluids, benefitting commercial suppliers.

2. Underpinning research

Peritoneal dialysis (PD) provides a home-based treatment choice that enables people to survive with kidney failure. For over 20 years Keele has been a world leader in PD research, demonstrating that peritoneal membrane function is associated with survival and that exposure to dialysis fluid, especially a high glucose concentration, can cause damage and reduce the ability of the membrane to remove fluid. This in turn causes overhydration of the patient which is strongly associated with reduced survival. Since 2000, a series of cohort studies and clinical trials led, or co-led, by Keele researchers has expanded understanding of this problem and shown how different approaches to prescribing PD can improve fluid removal and avoid membrane injury. Studies include the European Automated Peritoneal Dialysis Outcome Study (EAPOS) [3.1]; Global Fluid Study (GFS) [3.2]; Stoke PD Study [3.3]; Peritoneal Dialysis Competitive Risk Analysis For Long-Term Outcomes (PD-CRAFT) [3.4]; European Icodextrin Trial [3.5]; and UK-Shanghai Bioimpedance Trial [3.6].

Progressive damage of the peritoneal membrane by glucose is of two types: firstly, there is a longitudinal increase in the speed of small solute transfer across the membrane [3.1], which we previously showed to be an independent predictor of worse survival because it reduces fluid removal. We have now demonstrated that this is mediated by local inflammation [3.2]. Secondly, there can be disproportionate reduction in the efficiency of fluid removal by the membrane due to thickening that increases the risk of encapsulating peritoneal sclerosis [3.3]. This rare but severe complication of PD prevents the gastro-intestinal tract from working properly, causing pain and malnutrition and sometimes requiring major surgery, which has a significant mortality risk. We demonstrated that the risk of this condition is negligible for older patients with more comorbid conditions due to the competing risk of death from other causes, but for younger patients, this risk of peritoneal sclerosis over time is important [3.4].

Benefits of alternative approaches to high glucose prescription. There are three ways in which membrane injury and associated survival risk can be mitigated: (1) Using automated peritoneal dialysis (APD) which increases the efficiency of glucose in removing fluid [3.1]; (2) use of the polymer, icodextrin, as an alternative to glucose [3.1,3.5]; (3) avoidance of unnecessary increases in glucose to remove fluid by maintaining residual kidney function, which also keeps fluid status stable [3.6]. Use of icodextrin and APD in EAPOS [3.4], a study conducted in 21 European countries, mitigated both types of membrane injury and the mortality risk from fast membrane solute transfer was eliminated. In a trial comparing the use of glucose with icodextrin [3.5] we demonstrated that fluid reabsorption across the peritoneal membrane could be prevented when using icodextrin, improving overhydration while reducing glucose exposure of the peritoneal membrane. The UK-Shanghai trial [3.6] used bioimpedance assessment of body composition to guide and improve management of fluid status. Results showed that when residual kidney function was maintained, patients did not become overhydrated, obviating the need for increased membrane glucose exposure. Taken together, these studies provide clinicians with alternative strategies to manage fluid status, with the potential to improve survival while avoiding excessive exposure of the peritoneal membrane to glucose.

3. References to the research

3.1 Davies SJ, Brown EA, Frandsen NE, Rodrigues AS, Rodriguez-Carmona A, Vychytil A, Macnamara E, Ekstrand A, Tranaeus A, Divino Filho JC, on behalf of the EAPOS group. Longitudinal membrane function in functionally anuric patients treated with APD: data from EAPOS on the effects of glucose and icodextrin prescription. Kidney Int, 2005;67(4):1609-15 Citations 195

3.2 Lambie M, Chess J, Donovan KL, Kim YL, Do JY, Lee HB, Noh H, Williams PF, Williams AJ, Davison S, Dorval M, Summers A, Williams JD, Bankart J, Davies SJ, Topley NT on behalf of the Global Fluid Study Investigators. Independent effects of systemic and peritoneal inflammation on peritoneal dialysis survival. Journal Am Soc Nephrol, 2013;24(12):2071-80 Global Fluid Study, Citations 118

3.3 Lambie M, John B, Mushahar L, Huckvale K, Davies SJ. The peritoneal osmotic conductance is low well before the diagnosis of encapsulating peritoneal sclerosis in made. Kidney International 2010;28(6):611-618. Stoke PD Study: Citations 94

3.4 Lambie M, Teece L, Johnson D, Petrie M, Mactier R, Solis-Trapala I, Belcher J, Bekker H, Wilkie M, Tupling K, Phillips-Darby, Davies, SJ. Estimating Risk of Encapsulating Sclerosis Accounting for Competing Risk of Death: Nephrology Dialysis Transplantation 2019:34(9);1585-91 PD-CRAFT, Citations 5

3.5 Davies, S. J., Woodrow, G., Donovan, K. Plum, J., Williams, P., Johansson, A. C., Bosselmann, H. P., Heimburger, O., Simonsen, O., Davenport, A., Tranaeus, A., and Divino Filho, J. C. Icodextrin improves the fluid status of peritoneal dialysis patients: results of a double-blind randomized controlled trial. J Am Soc Nephrol 2003; 14:2338-44. European Icodextrin Study, Citations: 347

3.6 Tan BK, Yu Z, Fang W, Lin A, Ni Z, Qian J, Woodrow G, Jenkins S, Wilkie M, Davies SJ Longitudinal bioimpedance vector plots add little value to fluid management of peritoneal dialysis patients. Results of the UK-Shanghai BIA trial Kidney Int; 2015;89(2):487-97 UK -Shanghai Study, Citations: 30

4. Details of the impact

Evidence of a relative and sustained improvement in survival on peritoneal dialysis compared to haemodialysis since research was published

Survival analyses from the US Renal Data System [5.1a] show that “adjusted all-cause mortality in prevalent patients receiving hemodialysis decreased from 192.9 per thousand in patient-years in 2009 to 164.6 in 2018. The decrease was even greater in patients receiving PD, in whom the mortality rate decreased from 164.2 to 131.5. Median survival among incident hemodialysis patients improved from approximately 37 months in 2003 to 42 months 2008 and to 47 months in 2013 (Figure 5.7) [5.1a] . The improvement was even greater for patients initiating PD”.

In 2016, the European Renal Registry reported on sequential cohorts starting dialysis in which survival used to be equivalent for these different types of dialysis, but progressively has been disproportionately better for those treated with PD [5.1b]. The authors of this publication argue this was not due to changes in patient selection, suggesting that improvement in survival on PD, amongst other things, is likely to reflect better fluid management, appreciation of the value of residual kidney function and the greater importance of fluid versus solute removal. Research at Keele has focussed primarily on these issues and we have consistently shown that peritoneal membrane function, which is crucial to fluid removal, predicts survival [3.2]. This early survival benefit for PD is still evident in the most recent annual European Registry report (2018, Figure A.5.1) [5.1c].

How our research has influenced guidance on peritoneal dialysis prescription

Evidence-based guidance on dialysis prescription worldwide is led by the International Society of Peritoneal Dialysis (ISPD). Their regular publications of guidelines are highly cited, downloaded and viewed [5.2]. Our research is well represented in the most recent, as well as previous, iterations of this guidance, including prescribing high-quality PD [5.2] for people with cardiovascular disease, guidance on how long patients should remain on peritoneal dialysis [5.3] and, most recently, the evaluation of peritoneal membrane function [5.4]. Specifically, our research has contributed to this guidance in the following ways:

(a) Our research on membrane function [3.1; 3.2; 3.3] informed a new framework for classifying types of membrane dysfunction and recommendations on how membrane function is evaluated in the clinic [5.4]; the avoidance of excessive use of high glucose concentrations [3.1; 3.3] (and replacement with icodextrin if available) [5.2; 5.2; 5.4]; and how to assess the risk of encapsulating peritoneal sclerosis [3.2; 3.3; 3.4 – data used by the guideline committee and published subsequently] taking competing risks into account [5.3].

(b) Use of icodextrin to improve ultrafiltration: our trial [3.5] - the first to show that icodextrin improves fluid removal and hydration status in people with fast membrane solute transfer - is included in all systematic reviews of trial evidence [5.5 (Cochrane Review); 5.6, “Our systematic review demonstrates substantial clinical benefits for icodextrin based on high level evidence”,] used to underpin the ISPD guidelines [5.2; 5.4].

(c) The value of residual kidney function in maintaining stable fluid status was demonstrated in our trial [3.6], the only longitudinal study linking these parameters [5.2]

Evidence this guidance has impact through adopted practice and patient benefit

(a) The use of automated peritoneal dialysis to mitigate the mortality risk in patients with fast membrane transport, a strategy that follows directly from our research, was associated with a partial reduction in mortality and hospitalisation risk in a study of >10,000 patients treated by a Large Dialysis Organisation, (Davita, based in the US) [5.7].

(b) A report of data from the international Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) shows that across the world icodextrin is preferentially prescribed in people with fast membrane solute transport. This has also translated into less use of high glucose concentrations and a maintenance of equivalent fluid removal [5.8]

Supporting shared decision making

Funded by Kidney Research UK and in collaboration with Hilary Bekker (Professor of Medical Decision Making at Leeds University), we have ensured that our research supports shared decision making through the development of a Dialysis Decision Aid, first made available in 2015 and recently updated. This decision aid, developed in collaboration with nurses and patients, including those at our affiliated clinical unit (University Hospital of North Staffordshire), supports patients in choosing the type of dialysis they will have, and the choice between home and hospital-based treatments. Used in 1/3 of kidney units, the tool is also available to patients on the Kidney Research UK website [5.9] (typically 600 patient downloads per year). It is endorsed by NICE, European Best Practice Group, quality tested by the International Decision Aid Library Inventory System and included as an online decision aid on https://www.thinkkidneys.nhs.uk/ckd/tools-for-change/patient-decision-aids/ and international Med-Decs https://www.med-decs.org/en/kidney-failure websites. It has also been translated into Spanish (by the Spanish Society of Nephrology) and Italian (by the Italian Association of Kidney Patients). Incorporated in the Dialysis Decision Aid is information derived from our research on the risk of developing encapsulating peritoneal sclerosis, which is extremely low for older patients [3.4].

Impact on industry

Baxter HealthCare, the largest global company producing PD solutions and the exclusive manufacturer of icodextrin (commercially called Extraneal) have used our research to demonstrate the added clinical value of this product. They have now obtained licences for its use across the world [5.10].

5. Sources to corroborate the impact

[5.1] Sustained improvement in mortality on peritoneal dialysis relative to haemodialysis.

(a) US Renal Data System (data up to 2018), https://adr.usrds.org/2020/end-stage-renal-disease/5-mortality Figure 5.7

and (b) Trends in dialysis modality choice and related patient survival in the ERA-EDTA Registry over a 20-year period, NDT, 31:2016 https://doi.org/10.1093/ndt/gfv295

and (c) ERA-EDTA Annual Report 2018, Page 33, Figure A.5.1 https://www.era-edta.org/registry/AnnRep2018.pdf

[5.2] Testimonial of Adoption of Intenational Summary of Guidelines (Editor, Peritoneal Dialysis International) Dec 2020.

ISPD prescription guidelines. Prescribing High Quality Goal-Orientated Peritoneal Dialysis (The over-arching guideline paper). Brown EA, Blake PG, Boudville N, Davies S, De Arteaga J, Dong J, Finkelstein F, Foo M, Hurst H, Johnson DW, Johnson M, Liew A, Moraes T, Perl J, Shroff R, Teitelbaum I, Wang AY, Warady B. International Society for Peritoneal Dialysis practice recommendations: Prescribing high-quality goal-directed peritoneal dialysis. Perit Dial Int. 2020 Jan 21:896860819895364. DOI: 10.1177/0896860819895364

Underpinning evidence - Wang AY, Dong J, Xu X, Davies S. Volume management as a key dimension of a high-quality PD prescription Perit Dial Int. 2020;40(3):282-292 DOI: 10.1177/0896860819895365 And also, see guideline 2.2.3 in Wang AY, Brimble KS, Brunier G, Holt SG, Jha V, Johnson DW, Kang SW, Kooman JP, Lambie M, McIntyre C, Mehrotra R, Pecoits-Filho R. ISPD Cardiovascular and Metabolic Guidelines in Adult Peritoneal Dialysis Patients Part I - Assessment and Management of Various Cardiovascular Risk Factors. Perit Dial Int. 2015 Jul-Aug;35(4):379-87. DOI: 10.3747/pdi.2014.00279. PMID: 26228782; PMCID: PMC4520720

*[5.3] International Society of Peritoneal Dialysis guidance on how long a patient should remain on peritoneal dialysis without risking membrane injury and encapsulating peritoneal sclerosis. In this guideline 8/104 of the references are from our research – more than any other single group. See references 83, 89 and highlighted text describing PD-CRAFT study findings prior to publication. Brown EA, Bargman J, van Biesen W, Chang MY, Finkelstein FO, Hurst H, Johnson DW, Kawanishi H, Lambie M, de Moraes TP, Morelle J, Woodrow G. Length of Time on Peritoneal Dialysis and Encapsulating Peritoneal Sclerosis - Position Paper for ISPD: 2017 Update. Perit Dial Int. 2017 Jul-Aug;37(4):362-374. DOI:10.3747/pdi.2017.00018

[5.4] * ISPD Recommendations for the evaluation of peritoneal membrane dysfunction in adults: classification, measurement, interpretation and rationale for intervention* Johann Morelle, Joanna Stachowska-Pietka, Carl Öberg, Liliana Gadola, Vincenzo La Milia, Zanzhe Yu, Mark Lambie,⁷ Raj Mehrotra, Javier de Arteaga, Simon Davies DOI: 10.1177/0896860820982218

[5.5] Use of icodextrin to improve ultrafiltration. Systematic Review of Evidence Htay H, Johnson DW, Wiggins KJ, Badve SV, Craig JC, Strippoli GF, Cho Y. Biocompatible dialysis fluids for peritoneal dialysis. Cochrane Database Syst Rev. 2018 Oct 26;10:CD007554 DOI: 10.1002/14651858.CD007554.pub3.

[5.6] Goossen K, Becker M, Marshall MR, et al. Icodextrin Versus Glucose Solutions for the Once-Daily Long Dwell in Peritoneal Dialysis: An Enriched Systematic Review and Meta-analysis of Randomized Controlled Trials. Am J Kidney Dis. 2020;75(6):830-846. DOI: 10.1053/j.ajkd.2019.10.004

[5.7] Mehrotra R, Ravel V, Streja E, Kuttykrishnan S, Adams SV, Katz R, Molnar MZ, Kalantar-Zadeh K. Peritoneal Equilibration Test and Patient Outcomes. Clin J Am Soc Nephrol. 2015 Nov 6;10(11):1990-2001. doi: 10.2215/CJN.03470315 This large cohort study confirms the detrimental effect of high solute transport membrane function on survival and demonstrates the mitigating effect of using Automated Peritoneal Dialysis.

[5.8] Analysis of Icodextrin prescribing practice from the International Peritoneal Dialysis Outcomes and Practice Patterns Study. Report from Arbor Research Collaborative for Health on the Data from the International PDOPPS study that shows that across the world icodextrin is preferentially prescribed in people with fast membrane solute transport.

[5.9] Dialysis Decision Aid. https://www.kidneyresearchuk.org/DialysisDecisionAid See page 45 reference 12 and page 48 reference Lambie and Davies as research team.

[5.10] Evidence that there has been, since 2000, a sustained increase in the use of APD and uptake of icodextrin use in countries where this is available. (Testimonial, Baxter HealthCare).

Raising the international quality of osteoarthritis management in primary care

Submitting institution: University of Keele
Unit of assessment: 3 - Allied Health Professions, Dentistry, Nursing and Pharmacy
Summary impact type: Health
Is this case study continued from a case study submitted in 2014?: No

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1. Summary of the impact

Our osteoarthritis research developed new understanding of the number of people with osteoarthritis and its personal and societal impact, informing health policy nationally (Public Health England Health Profile of England reports) and internationally (National Public Health Agenda: 2020 CDC). Our research examining osteoarthritis risk factors and effective treatments informed international clinical guidelines (UK NICE, US Defence Department, Australian Commission Safety and Quality). Implementation of our research transformed primary healthcare services in Europe (JIGSAW-E), with an estimated 40 million patients benefiting through improved access to more consistent, evidence-based care, and equipping healthcare professionals to implement our research and high-quality osteoarthritis care.

2. Underpinning research

Osteoarthritis is a leading cause of disability globally, yet care remains suboptimal. Our interdisciplinary osteoarthritis research group (led by Peat (Epidemiology), Jinks (Social Science) and Dziedzic (Implementation)) has 15 members combining clinical expertise (general practice, nursing, rheumatology and physiotherapy), biostatistics and epidemiology, qualitative/mixed methods, clinical trials, exercise science and service redesign. Strong patient and public involvement and engagement underpins our research (3.1) which highlights the international importance of osteoarthritis to population health and healthcare services. Our definition, evaluation, and implementation of high-quality osteoarthritis care has transformed osteoarthritis care provision in Europe.

Highlighting the impact of osteoarthritis in populations

Multiple studies have provided new and improved estimates of how many people have osteoarthritis, why people get it, the negative impact on individuals, society, and social participation (3.2), how symptoms change over time, and improved international osteoarthritis healthcare provision (3.1-3.6). We identified an increase in diagnosis of osteoarthritis in populations born after 1950 (3.3) but also that many community-based older adults with joint pain (likely to be osteoarthritis), do not have this formal diagnosis recorded (3.3). This is important as it is linked to patients receiving suboptimal care. Our identification of different patterns of osteoarthritis pain experienced by different people over time (3.5) dispelled myths among patients and healthcare professionals that osteoarthritis is inevitably progressive. We have identified modifiable risk factors (i.e., obesity) that impact on the development of osteoarthritis (3.4). We identified the strongest predictors of future pain and functional limitation (baseline pain, function, low physical activity, poor general health, obesity and socioeconomic indicators) (3.1). Consequently, we demonstrated the potential population level benefits of effective non-pharmacological approaches to treatment and prevention for osteoarthritis and have supported patient information provision about what can be done to change patient outcomes.

Defining and evaluating current osteoarthritis primary care

We empirically derived osteoarthritis quality indicators to define high-quality primary care (3.1). Within primary care, our research on diagnosis of osteoarthritis and support for self-management identified a primary care evidence-practice gap (3.1). This gap is sub-optimal use of core non-pharmacological and pharmacological approaches recommended by the National Institute for Health and Care Excellence (NICE) (3.1). We have provided definitive evidence for the value of exercise as core management for osteoarthritis (3.1, 3.6), yet shown general practitioners, practice nurses and physiotherapists practice inconsistently when optimising exercise for osteoarthritis (3.1).

Optimising osteoarthritis care

Building on our knowledge of patterns of osteoarthritis symptoms, the social consequences and potential unmet care needs of people with osteoarthritis, we have developed and tested key innovations to transform primary care provision for osteoarthritis. We used internationally recognised NICE recommendations (3.1) as a foundation for our innovations, which were developed to support high quality primary care provision, self-management, and roll-out at study end. The 4 innovations are: a model osteoarthritis consultation (co-designed with patients and practitioners) (3.1); an osteoarthritis patient guidebook co-produced with patients and carers (3.1); an electronic health record template to support delivery and recording of high-quality primary osteoarthritis care (3.1); and a multidisciplinary healthcare professional training programme (3.1).

3. References to the research

3.1. Hay E, Dziedzic K, Foster N, Peat G, van der Windt D, Bartlam B, Blagojevic-Bucknall M, Edwards J, Healey E, Holden M, Hughes R, Jinks C, Jordan K, Jowett S, Lewis M, Mallen C, Morden A, Nicholls E, Ong BN, Porcheret M, Wulff J, Kigozi J, Oppong R, Paskins Z, Croft P. Optimal primary care management of clinical osteoarthritis and joint pain in older people: a mixed-methods programme of systematic reviews, observational and qualitative studies, and randomised controlled trials. DOI: 10.3310/pgfar06040. Programme Grants Appl Res 2018;6(4).

3.2. Theis KA, Murphy L, Hootman JM, Wilkie R. Affiliations expand Social participation restriction among US adults with arthritis: a population-based study using the International Classification of Functioning, Disability and Health Arthritis Care Res (Hoboken). 2013 Jul;65(7):1059-69. DOI: 10.1002/acr.21977. PMID: 23401463 PMCID: PMC4466902

3.3. Yu D, Jordan KP, Bedson J, Englund M, Blyth F, Turkiewicz A, Prieto-Alhambra D, Peat G. Population trends in the incidence and initial management of osteoarthritis: age-period-cohort analysis of the Clinical Practice Research Datalink, 1992-2013. Rheumatology 2017; 56(11):1902-1917. DOI: 10.1093/rheumatology/kex270.

3.4 Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis and Cartilage 2010;(18): 24-33. DOI: 10.1016/j.joca.2009.08.010

3.5 Nicholls E, Thomas E, van der Windt DA, Croft PR, Peat G. Pain trajectory groups in persons with, or at high risk of, knee osteoarthritis: findings from the Knee Clinical Assessment Study and the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2014;22(12):2041-50. DOI: 10.1016/j.joca.2014.09.026. Epub 2014 Oct 8.PMID: 25305072

3.6 Uthman OA, van der Windt D, Jordan J, Dziedzic KS, Healey EL, Peat GM, Foster NE. Exercise for lower limb osteoarthritis: systematic review incorporating trial sequential analysis and network meta-analysis. BMJ 2013;347:f5555. DOI: https://doi.org/10.1136/bmj.f5555

4. Details of the impact

Influencing national and international health policy

We extended understanding of osteoarthritis and influenced international health policy by moving beyond reliance on measures of knee and hip osteoarthritis, as this condition can affect all, and often multiple, joints. Our research on the number of people with osteoarthritis and why people get it (epidemiological estimates) (3.3) have been integrated into The Global Health Data Exchange and Global Burden of Disease models of the burden of osteoarthritis (5.1). The estimates have been used within Public Health England (PHE) burden of disease (5.2), and Versus Arthritis policy reports (5.3). Our active partnerships with Versus Arthritis and PHE, raised awareness of osteoarthritis in the public and political domain, prompting prioritisation of musculoskeletal health by PHE in 2018 (5.3). Our research collaborations recognised osteoarthritis-related social participation disruption (3.2) and shaped the recent National Public Health Agenda for Osteoarthritis in the US: 2020 update for the Center for Disease Control (5.4).

Improving international and national clinical guidelines and supporting professional practice

We have underpinned core management guidelines internationally for example in the US and Australia (5.5) and UK, NICE (5.6, 5.7) and guided NHS commissioners (5.7, 5.10). These impacts have been achieved by highlighting modifiable risk factors for the development and progression of osteoarthritis (3.4), providing definitive evidence for the use of exercise (3.6), providing innovations for use in practice (i.e., Osteoarthritis (OA) guidebook) (3.1), and supporting cost and clinically effective care (3.1). Our OA quality indicators (3.1) informed the 2014 NICE osteoarthritis guidelines (5.7) and are reflected in the associated NICE quality indicators. Our resulting OA e-template (3.1) was endorsed by NICE and made available to clinicians to download (5.8). Our four innovations have thus benefitted patients, healthcare organisations and commissioners by supporting provision of more consistent, cost-effective, evidence-based care, aligned with NICE recommendations.

Improving quality and accessibility of osteoarthritis primary care to patients

High quality osteoarthritis written information is a key part of osteoarthritis management. Our co-produced guidebook (led by our patient members) (3.1) combined scientific understanding with lived experiences of osteoarthritis and rectified the variable quality of existing information. This approach was valued, and the guidebook adopted, by the Arthritis and Musculoskeletal Alliance Knowledge Hub (5.9) and recommended as excellent by Red Whale (a national primary care education provider) for use during remote working due to the COVID-19 pandemic (5.11). Over 1,550 hard copies have been disseminated. An electronic version of the guidebook has been incorporated within the Keele Pain Recorder Application (5.9). This App has been adopted by the EMIS App Library and NHS digital library to support patients to record symptoms and consult with painful conditions. Consequently, the reach of the guidebook has been extended to >1,000 downloads across 9 countries (UK, China, USA, Australia, France, Malaysia, UAE, India, Italy).

Uniquely, we have improved access to high quality care by equipping community pharmacies to undertake osteoarthritis care provision. We adapted our model consultation (3.1) and delivered training to equip 44 members across 9 Shropshire Clinical Commissioning Group pharmacies. In Staffordshire, Clinical uptake of the NICE guidelines has been recognised by a NICE Shared Learning Award for physiotherapy (5.10). Additionally, we partnered with industry (Lloyds Pharmacy) and co-wrote information on pharmacological and non-pharmacological management of osteoarthritis provided to patients as part of their seasonal national pain campaign. Company metrics revealed a positive impact on patient engagement, including approximately 12,000 page views on the Lloyds arthritis pain webpage, and projected revenue for pain products was exceeded in the first year of the campaign (5.12).

Equipping healthcare professionals to better manage osteoarthritis

Our research has developed healthcare professional training across Europe to improve knowledge and confidence to deliver high quality osteoarthritis care and has been implemented through face-to-face UK training (n=355), one-off events (i.e., Red Whale in association with Versus Arthritis Webinar (n=500 by December 2019)) (5.11), e-learning packages (i.e., British Medical Journal (BMJ) Learning Osteoarthritis module (completed 13,400 times by February 2020, personal communication)), pharmacists online training (n=153) (5.9), physiotherapist online training (n=104) (5.9) and European League against Rheumatology (EULAR) Training Modules on osteoarthritis for Rheumatologists and healthcare professionals.

Transforming international healthcare service provision

We have transformed international osteoarthritis primary care service provision by implementing our 4 osteoarthritis innovations (3.1) within the Joint Implementation of Guidelines for Osteoarthritis Across Western Europe (JIGSAW-E) project, funded by the West Midlands Academic Health Science Network and the EU (European Institute of Innovation and Technology (EIT)-Health) (5.9). JIGSAW-E supported primary care providers in five European countries to address the unmet needs of adults with osteoarthritis through the systematic implementation of international guidelines for the best care and management of osteoarthritis.

Internationally we have trained 195 multi-disciplinary healthcare professionals in 5 countries (UK, Netherlands, Denmark, Portugal, Norway). Led by our patient and public involvement (PPI) members who worked with colleagues internationally, we culturally adapted and translated our OA guidebook into four other languages (5.9). In the Netherlands the new guidebook was endorsed by the patient organisation Poly-Artrose Lotgenoten Vereniging (5.9). International relevance and value of our research implementation was recognised by the Osteoarthritis Research International (OARSI) Joint Effort Initiative, when it featured among seven remote osteoarthritis management programmes recommended in the COVID response (5.9). The EIT also adopted our implementation research to provide help to “ some 40 million EU citizens who would benefit from osteoarthritis Healthcare Transformation (5.9). Patients also valued improved osteoarthritis care: “…pain relief and increased mobility are possible. Take the first positive step to achieving your goals with the help of your GP or Practice Nurse – you won’t regret it!” (JIGSAW-E Patient) (5.9).

The Care and Management of Gout in Primary Care

Submitting institution: University of Keele
Unit of assessment: 3 - Allied Health Professions, Dentistry, Nursing and Pharmacy
Summary impact type: Health
Is this case study continued from a case study submitted in 2014?: No

Download case study PDF

1. Summary of the impact

Our world-leading multidisciplinary research has raised the profile of the impact of gout on patients and the public, influenced national and international clinical guidelines and resources to allow practitioners to improve clinical management. It has increased understanding of people’s experiences of living with gout, shaped policy and practice, nationally and internationally, and influenced training in primary care and rheumatology. Our research has transformed clinical care through the creation of public-facing resources, such as our module for healthtalk.org, which provides patients with online information about gout and how it affects people’s lives.

2. Underpinning research

Gout is the most common inflammatory arthritis. Its prevalence and incidence are increasing, owing to population ageing and rising rates of comorbidity and obesity. Gout causes excruciating flares of joint pain and swelling, long-term joint damage and impaired health-related quality of life (HRQOL). It is well-understood, yet management is frequently suboptimal.

Based in Keele’s Primary Care Centre Versus Arthritis, our gout research group was established in 2008 and published its first research paper in 2010. Led by Roddy (rheumatologist) our multidisciplinary team combines expertise in general practice (Mallen, Clarson), nursing (Finney), dietetics (Watson), quantitative (Muller, Bucknall, Bajpai, Whittle) and qualitative (Richardson, Liddle) methods, and the patient and public’s perspective, to undertake high-quality randomised trials, epidemiological and qualitative studies with the aim of improving the management of gout in primary care. Patients and members of the public have helped us to prioritise research questions, design studies (informing, for example, recruitment methods, eligibility criteria, choice of outcomes), and oversee research through Trial Steering Committee membership.

We described rising prevalence and incidence of gout in the UK between 1997 and 2012 ( 3.1). Prevalence peaked at 2.5% in 2012 but suboptimal management persisted, with only 40% of patients receiving definitive treatment with allopurinol throughout this period.

We undertook a qualitative interview study to explore people’s experience of having gout and identify the issues relating to the causes, diagnosis, and treatment that are important to them. We found that patients’ lack of confidence in and resistance to the diagnosis of gout occurred in response to their misconceptions about its causes and perceived characteristics of gout sufferers ( 3.2). Patients and the public may be unaware that gout is a chronic condition requiring long-term treatment, perpetuating suboptimal management.

Using data from the Clinical Practice Research Datalink (CPRD), we have identified novel, important associations between gout and comorbidities such as vascular disease, sleep disorders, venous thromboembolism and sexual dysfunction. We undertook a large cohort study in CPRD, finding that both men and women with gout are at increased risk of vascular events but risk is greater in women than men ( 3.3). We have shown the burden of chronic kidney disease (CKD) in patients with gout, 24% of people with gout have CKD and the risk of CKD in people with gout is over twice that of the general population ( 3.4). This has led to work demonstrating distinct comorbidity clusters in people with gout.

We performed a systematic review to describe the impact of gout on HRQOL ( 3.5). We found that although both gout and coexisting health conditions contribute to poor HRQOL; gout is associated with impaired HRQOL even after adjusting for these other conditions.

We led the CONTACT trial which is the largest-ever gout flare trial undertaken in primary care (399 participants from 100 general practices) and the first direct head-to-head comparison of a non-steroidal anti-inflammatory drug (naproxen) and colchicine, the most common drug treatments for gout flares ( 3.6). We showed no difference between naproxen and colchicine for pain, but found naproxen was associated with less use of analgesics, fewer side-effects and was more cost-effective.

4. Details of the impact

Impact on updated national and international gout management guidelines

Our research features in national and international guidelines ( 5.1, 5.2, 5.3). The rising prevalence and incidence of gout ( 3.1) was cited as key justification for the updated 2016 European League Against Rheumatism (EULAR) recommendations (co-author Mallen) and 2017 British Society for Rheumatology (BSR) guidelines (lead Roddy, co-author Mallen) ( 5.1, 5.2). Our work demonstrating increased cardiovascular risk in people with gout ( 3.3) underpinned the EULAR recommendations’ overarching principle that every person with gout should be screened for associated comorbidities and cardiovascular risk ( 5.1). Our systematic review highlighting the prevalence of chronic kidney disease (CKD) in people with gout ( 3.4) was cited in the BSR guideline to support including a specific section dedicated to treating gout in patients with CKD, given the challenges of managing these patients ( 5.2). A key change in these guidelines from earlier versions was a shift to recommend earlier commencement of definitive pharmacological urate-lowering therapy ( 5.1, 5.2). Both guidelines cited our systematic review of the impact of gout on quality of life ( 3.5) as key evidence underpinning this shift. The CONTACT trial ( 3.6) was included in the systematic review and network meta-analysis which informed the recommendation in the American College of Rheumatology 2020 guideline that NSAIDs and colchicine are appropriate first-line therapy for gout flares ( 5.3).

The updated EULAR recommendations and BSR guidelines were both cited in the National Institute for Health and Care Excellence (NICE) Gout Clinical Knowledge Summary 2018 ( 5.4). The BSR guideline was accredited by NICE and endorsed by the Royal College of General Practitioners ( 5.2). It was included in the journal Rheumatology’s “Best of 2017” as one its five most downloaded papers in 2017 (viewed online >5200 times in the first 12 months following publication) ( 5.5) and voted the 4^th most useful, interesting, or practice-changing paper from 2017 by Red Whale, a leading provider of UK primary care medical education ( 5.6).

Impact on international expert consensus on gout terminology and disease labels

Lack of clarity regarding the communication of disease-related concepts in clinical settings identified by our qualitative study ( 3.2) was cited as key justification for a recent international consensus exercise involving 79 experts in gout from 22 countries, led by the international, multidisciplinary, collaborative Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN) network to agree terminology for gout disease states, published in 2019 ( 5.7).

Understanding patients’ experiences of gout

Prior to merging with Arthritis Research UK to form Versus Arthritis, Arthritis Care was the UK’s largest organisation working with and for people with arthritis. In 2014, it undertook a large survey of people’s experiences of having gout (co-authors Roddy, Mallen). Our research ( 3.1) was cited prominently in the resulting Gout Nation report ( 5.8), inspiring Arthritis Care’s Gout Awareness month in 2015.

Developing freely accessible patient-facing material

We worked with patients and members of the public to develop patient-facing educational materials about gout to support patients, carers and healthcare professionals. Healthtalk.org is managed by Oxford-based Dipex Charity, whose mission is to help and inform patients, carers and healthcare professionals by sharing freely accessible, personal, real-life health experiences. Published in 2014, the content of our online healthtalk gout resource arose directly from our qualitative research ( 3.2) and has been viewed 428,016 times since going live in 2014 with positive public comments and feedback through the webpages (personal correspondence from Dipex, June 2020). The gout videos are viewed around 4,000 times per month ( 5.9).

Developing the Multidisciplinary Workforce Internationally

As lead author of the Crystal Arthropathy module of the EULAR on-line course, Roddy has implemented our research describing gout’s rising prevalence and incidence: its impact on quality of life was cited to emphasise the burden posed by gout ( 3.1, 3.5). The module targets knowledge and skills to suit the final years of rheumatology training ( 5.10) and has been accessed by 1540 students since 2016.

Inspired by our paper describing suboptimal management of gout ( 3.1), our local Clinical Commissioning Group’s Practice Nurse evidence-based practice group investigated the benefits of nurse-led gout consultations as a Critically Appraised Topic and audited management of gout across six local practices. After identifying sub-optimal practice, current guidelines were circulated to over 200 practice nurses at 134 practices across North Staffordshire and South Cheshire. The BSR guidelines were also shared on a dedicated website for the group. Subsequently, 30 primary care nurses have opted for additional gout training to improve their practice and expressed interest in participating in a randomised trial of nurse-led gout care.

5. Sources to corroborate the impact

5.1 Richette P, Doherty M, Pascual E, Barskova V, Becce F, Castaneda-Sanabria J, et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis 2016;76(1):29-42. doi: 10.1136/annrheumdis-2016-209707. Epub 2016 Jul 25. [International Guideline]

5.2 Hui M, Carr A, Cameron S, Davenport G, Doherty M, Forrester H, et al (2017). The British Society for Rheumatology Guideline for the Management of Gout. Rheumatology 2017;56(7):1246. doi: 10.1093/rheumatology/kex250. [National Guideline]

5.3 FitzGerald JD, Dalbeth N, Mikuls T, Brignardello-Petersen R, Guyatt G, Abeles AM, Gelber AC, Harrold LR, Khanna D, King C, Levy G, Libbey C, Mount D, Pillinger MH, Rosenthal A, Singh JA, Sims JE, Smith BJ, Wenger NS, Bae SS, Danve A, Khanna PP, Kim SC, Lenert A, Poon S, Qasim A, Sehra ST, Sharma TSK, Toprover M, Turgunbaev M, Zeng L, Zhang MA, Turner AS, Neogi T. 2020 American College of Rheumatology Guideline for the Management of Gout. Arthritis Care Res (Hoboken) 2020;72(6):744-760. doi: 10.1002/acr.24180. Epub 2020 May 11. [International Guideline] Appendix 7, Roddy (CONTACT) listed pg 1 and 43.

5.4 National Institute for Health and Care Excellence (NICE) Clinical Knowledge Summaries. Gout. https://cks.nice.org.uk/gout

5.5 Rheumatology journal, Oxford University Press. Best of 2017: https://academic.oup.com/rheumatology/pages/best\_of\_2017 ( Weblink no longer available but screen shot provided through Keele repository)

5.6 Red Whale. Red Whale's Top 10 from 2017. https://www.gp-update.co.uk/_enewsletter/2018/February/WLOGPs%20Top%20Ten%20from%202017?platform=hootsuite [national education. Red Whale is a leading primary care medical education provider (conferences attended by 15,000 primary care practitioners per year)]

5.7 Bursill D, Taylor WJ, Terkeltaub R, Abhishek A, So AK, Vargas-Santos AB, Gaffo A, Rosenthal A, Tausche AK, Reginato AM, Manger B, Scirè CA, Pineda C, van Durme C, Lin CT, Yin C, Albert DA, Biernat-Kaluza E, Roddy E, Pascual E, Becce F, Perez-Ruiz F, Sivera F, Lioté F, Schett G, Nuki G, Filippou G, McCarthy GM, Da Rocha Castelar-Pinheiro G, Ea HK, De Almeida Tupinambá H, Yamanaka H, Choi HK, Mackay JM, O’Dell JR, Vázquez-Mellado J, Singh JA, Fitzgerald JD, Jacobsson LTH, Joosten LAB, Harrold LR, Stamp LK, Andrés M, Gutierrez M, Kuwabara M, Dehlin M, Janssen M, Doherty M, Hershfield MS, Pillinger MH, Edwards NL, Schlesinger N, Kumar N, Slot O, Ottaviani S, Richette P, MacMullan P, Chapman P, Lipsky PE, Robinson PC, Khanna PP, Gancheva RN, Grainger R, Johnson RJ, Te Kampe R, Keenan RT, Tedeschi SK, Kim SC, Choi S, Fields TR, Bardin T, Uhlig T, Jansen TL, Merriman TR, Pascart T, Neogi T, Klück V, Louthrenoo W, Dalbeth N. Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN) consensus statement regarding labels and definitions of disease states of gout . Ann Rheum Dis 2019 Nov;78(11):1592-1600. doi: 10.1136/annrheumdis-2019-215933. Epub 2019 Sep 9.

5.8 Arthritis Care. Gout Nation Report. 2014. https://www.prnewswire.co.uk/news-releases/suffering-in-silence-new-statistics-prove-that-gout-is-no-laughing-matter-278341521.html. ( Report no longer publicly available download held within Keele’s repository).

5.9 Healthtalk.org Gout is a National Online Patient Resource. Available at: http://healthtalk.org/peoples-experiences/bones-joints/gout/topics. Advisory Panel led by Liddle J, Richardson J.

5.10 European League Against Rheumatism (EULAR) Online Course on Rheumatic Diseases (2 year course, current course 16th) and Faculty list. https://esor.eular.org/enrol/index.php?id=224

Transforming musculoskeletal therapies and services in primary care

Submitting institution: University of Keele
Unit of assessment: 3 - Allied Health Professions, Dentistry, Nursing and Pharmacy
Summary impact type: Health
Is this case study continued from a case study submitted in 2014?: No

Download case study PDF

1. Summary of the impact

Our programme of musculoskeletal (MSK) pain research has transformed services and care for those with common muscle and joint pain presenting to primary care. Our research has enhanced the information available to patients, supporting self-management and guiding those with MSK pain in seeking help, accessing treatment, and staying well. We have developed interventions, innovations and training to improve the way healthcare professionals help patients with MSK pain. These include new models of care and health service changes that have demonstrated return on investment and have impacted on policy, nationally and internationally, including being recommended by NICE and Public Health England.

2. Underpinning research

Our musculoskeletal (MSK) pain research (2.1-2.6), developed with patients and the public through our Research Users Group, investigates the impact of common aches and pains, promotes pro-active approaches to seeking help, accessing treatment, and staying well; with our research in health literacy forming our guiding principles. We have used knowledge gained from our research to stimulate action providing benefits for patients affected by MSK pain, influence policy, drive health service change, and underpin measures of the impact of MSK pain.

Seeking help

Seeking help is the first step in receiving healthcare for MSK conditions. However, our research has identified that in some regions >50% of the population have low health literacy, leading to challenges in seeking help, accessing support and self-management (2.1, 2.2). Patient information leaflets are routinely used to “signpost” health services and provide health information; they have been shown to affect patient health outcomes: however, many are poorly written. Our research across 17 general practices found that leaflets do not meet health literacy guidelines, therefore information is only accessible to higher skilled patients, leading to inequalities in healthcare (2.1). Our research has demonstrated that simplified MSK health communication, more time to process health information and supportive social networks help people understand and manage their MSK health on a day-to-day basis (2.2).

Accessing treatment

After patients have sought help for their MSK conditions they need to be able to access the best evidence-based treatments. We conducted one of the largest studies of occupational therapist-led treatment for MSK pain and demonstrated the clinical- and cost-effectiveness of their treatment approaches (2.3). The SMOOTH trial, with 257 participants, found that occupational therapists effectively supported self-management by patients with hand pain and osteoarthritis (OA). Patients receiving education about joint protection were more likely to respond to treatment than those that did not (33% versus 20% at 6 months, p=0.03), and hand exercises were cost-effective over 12 months (cost-per-QALY £64.51) (2.3).

We have also shown that a new model of primary care that involves direct access to physiotherapists for MSK pain is both clinically- and cost-effective (2.4). The STepping up the Evidence for Musculoskeletal Services (STEMS) trial, included 978 patients with MSK pain, set in general practice, 90% of patients needing physiotherapy used the service, with no safety issues. STEMS achieved similar clinical and cost outcomes as usual GP-led primary care and did not increase waiting times for physiotherapy, this work has resulted in policy-led service changes across the UK.

Staying well

Having sought help and accessed treatments it is important that patients are supported to continue their daily lives including work and monitoring of their MSK condition. We have developed, tested, and implemented a vocational advice intervention delivered in primary care that can reduce days lost from work due to MSK pain. The Study of Work And Pain (SWAP) trial (2.5), with 338 patients, demonstrated that adding a brief vocational advice service in primary care led to fewer days off work (mean 5 days less absence over 4 months), yielded net societal savings of £733 per person (£748 work absence gain at a healthcare cost of £15), with a return-on-investment of £49 for every £1 invested. This vocational advice service supported patients to self-manage their MSK pain and work, demonstrating significant improvements in self-efficacy to return-to-work. SWAP intervention training materials were developed to support scaled-up online learning and the vocational advice service has been implemented across 2 First Contact Practitioner (FCPs) services (I-SWAP study).

To support monitoring of MSK conditions, we have developed and tested new outcome measures for use with patients with MSK pain. The Musculoskeletal Health Questionnaire (MSK-HQ) provides clinicians and patients with an innovative tool to assess and monitor the impact of MSK pain (2.6). It was co-produced with healthcare professionals, academics, and patients to ensure it considers the outcomes most important to them. A validation study, with 570 patients, found high completion rates, excellent test-retest reliability, good validity when compared with reference standards, and high levels of acceptability to patients (2.6).

3. References to the research

2.1 Protheroe J, Estacio EV, Saidy-Khan S. Patient information materials in general practices and promotion of health literacy: an observational study of their effectiveness. Br J Gen Pract. 2015 Mar;65(632): e192-7. doi:10.3399/bjgp15X684013.

2.2 Adams J, Lowe W, Protheroe J, Lueddeke J, Armstrong R, Russell C, Nutbeam D, Ballinger C. Self-management of a musculoskeletal condition for people from harder to reach groups: a qualitative patient interview study. Disabil Rehabil. 2018, Oct (28):1-9. doi: 10.1080/09638288.2018.1485182.

2.3 Dziedzic K, Nicholls E, Hill S, Hammond A, Handy J, Thomas E, Hay E. Self-management approaches for osteoarthritis in the hand: A 2x2 factorial randomised trial. Annals of Rheumatic Diseases, 2015, 74(1):108-118, doi10.1136/annrheumdis-2013-203938

2.4 Bishop A, Ogollah RO, Jowett S, Kigozi J, Tooth S, Protheroe J, Hay EM, Salisbury C, Foster NE; STEMS study team. STEMS pilot trial: a pilot cluster randomised controlled trial to investigate the addition of patient direct access to physiotherapy to usual GP-led primary care for adults with musculoskeletal pain. BMJ Open. 2017 Mar 12;7(3): e012987. doi: 10.1136/bmjopen-2016-012987.

2.5 Wynne-Jones G, Artus M, Bishop A, Lawton SA, Lewis M, Jowett S, Kigozi J, Main C, Sowden G, Wathall S, Burton AK, van der Windt D, Hay EM, Foster NE. Effectiveness and costs of a vocational advice service to improve work outcomes in patients with musculoskeletal pain in primary care: a cluster randomised trial (SWAP trial ISRCTN 52269669). Pain. 2018;159(1):128–38.

2.6 Hill J, Kang S, Benedetto E, Myers H, Blackburn S, Smith S, Dunn KM, Hay E, Rees J, Beard D, Glyn-Jones S, Barker K, Ellis B, Fitzpatrick R, Price A. Development and initial cohort validation of the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways. BMJ Open. 2016;6: e012331.

4. Details of the impact

Patient information

To support self-management of hand pain and OA, we have worked with patients to produce patient information that has been implemented internationally through the European League Against Rheumatism (EULAR)’s Rheumatology Academy, with over 32,000 views of the informational video (5.1). Our work in health literacy has been cited as a national exemplar and ‘pioneering’ in the All Party Parliamentary Group Primary Care report (5 year Forward View, 2016) (5.2) and the Public Health England (PHE) report Health Literacy and Health Inequalities (2015) (5.3).

Transformed models of care and influenced policy

Our new models of primary care have been shown to have good return-on-investment (ROI) and are recommended by PHE (5.4), with STEMS (2.4) (patient self-referral) reporting a societal level ROI of £98.54 and SWAP (patient vocational advice) reporting an ROI of £11.14 (5.4).

Our work on improving access to physiotherapy has influenced the First Contact Practitioner (FCP) direction of policy in NHS England, with the new MSK pathway including self-referral to FCP services being rolled out across England’s Clinical Commissioning Groups and the devolved administrations (5.5). Recommendations by Versus Arthritis and the Royal College of General Practitioners that patients should be able to self-refer to MSK services have been supported by our research, which has evaluated NHS England’s FCP pilot and national roll-out (5.5).

The SWAP trial was highlighted as a key case study by PHE in its call for action to support healthy productive later life, which sets out the commitments to promote MSK health and prevent MSK conditions, aiming to achieving impact by 2023 (5.6). It was also included in the National Institute for Health Research (NIHR) Moving Forward document, showcasing the most high-quality evidence based MSK interventions with a direct call to implement these interventions in practice (5.7). SWAP intervention training materials were developed to support scaled-up online learning and the vocational advice service has been implemented among FCPs (I-SWAP study funded by the Joint Health and Work Department). This intervention is now being adapted and tested in a new research study, an NIHR funded randomised controlled trial (WAVE), with primary care patients also receiving fit-notes for time off work due to any health condition.

Influencing clinical guidelines and professional practice

The findings from our MSK pain research are embedded in national and international clinical guidelines and used to guide commissioners in planning and managing services to support patients (i.e., EULAR Guidelines for hand OA) (5.9). Our SMOOTH trial demonstrated that an occupational therapist (OT)-led joint protection intervention programme is effective. This was highlighted in a debate in Parliament during National Arthritis Week in 2016 (5.8) and incorporated in the European (5.9) and Canadian guidelines on the management of hand OA.

Furthermore, the intervention from our trial is now advocated internationally by healthcare professional organisations (i.e., Royal Australian College of General Practitioners) (5.10) and nationally (i.e., Royal College of General Practitioners). Video materials have been developed as part of the EULAR training programme for non-medical health professionals and have received over 28,000 views (24/12/20). A recent twitter campaign has led to 25,738 views of the OA hand exercises (4/12/20).

Evaluating MSK Health Status

Our MSK-HQ is fast becoming the preferred Patient Reported Outcome Measure (PROM) for use with patients with MSK pain. This measure seeks to better understand the impact of MSK pain and the effectiveness of interventions. The MSK-HQ is now recommended by NHS England [ https://www.england.nhs.uk/ourwork/clinical-policy/ltc/our-work-on-long-term-conditions/musculoskeletal/], and is available to licence from NHS Digital’s National Clinical Content Repository for collection of data into National datasets. It is recommended by the National MSK Health Data Group (5.11) and National Rheumatology Register ( https://www.rheumatology.org.uk/practice-quality/audits/neia-audit) to evaluate the performance and value for money of a wide range of interventions, and to improve the quality of healthcare services at a national level. It has been endorsed by the Chartered Society of Physiotherapy to improve monitoring of the progress of patients treated by physiotherapists, and it is the recommended MSK pain outcome of choice for Versus Arthritis (5.12). Individual licenses to 440 healthcare organisations (with the majority of licences allowing use with up to 1,000 patients) have been issued since 2017, supporting academic studies and healthcare organisations throughout the world (150 of the 440 licences are to UK NHS Trusts). The MSK-HQ has been translated into 8 languages, with 9 further translations in development. Completed translations are; Arabic, Chinese, Danish, Hungarian, Italian, Norwegian, Swedish and Turkish. Under development are; Bengali, German, Malay, Maori, Nepalese, Portuguese, Russian, Tamil and Welsh.

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