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- Is this case study continued from a case study submitted in 2014?
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1. Summary of the impact
The QPrediction tools are a set of validated risk prediction tools for identifying individuals at increased risk of conditions such as cardiovascular disease, diabetes, fracture or of having a currently undiagnosed cancer. High risk individuals can then be reviewed for treatments and interventions to reduce risk, or referred for potential earlier diagnosis. The tools have been extensively integrated into clinical practice by incorporation into NHS computer systems, including the major UK GP clinical system (EMIS) used in more than 55% of GP practices nationally, and covering a population in excess of 30,000,000 people. The tools are also recommended in 5 NICE guidelines. The cardiovascular risk tool (QRisk) is used in NHS Health Checks, estimated to prevent approximately 300 premature deaths and result in an additional 1,000 people free of cardiovascular disease, dementia, and lung cancer at age 80 years in England each year. QRisk has extensive public reach through initiatives supporting people to make lifestyle changes to reduce cardiovascular risk, such as the lifetime version of QRisk on the NHS One You website, which has been completed by over 1,200,000 people.
2. Underpinning research
The QPrediction risk tools are a novel set of validated risk prediction tools designed to estimate absolute risks for individuals of future outcomes such as cardiovascular disease, cancer, stroke, diabetes and fracture or an individual’s risk of having an existing undiagnosed disease, such as cancer. The overarching aim of the research has been to develop risk tools in large representative UK populations incorporating contemporaneous information on deprivation, ethnic group and specific clinical risk factors so that valid tools are available to identify high risk people most likely to benefit from treatments and interventions, leading to improved clinical outcomes and more effective targeting of resources.
The underpinning research involved using statistical modelling to derive clinical risk algorithms using routinely recorded electronic health data on patients’ characteristics, symptoms and risk factors in the QResearch database. The QResearch database was founded by Julia Hippisley-Cox in 2002 and contains primary care data linked to hospital, mortality and cancer records; it is one of the largest such databases in the UK and worldwide. The research to develop and validate the algorithms was undertaken by Julia Hippisley-Cox and Carol Coupland between 2007 and 2017.
The first algorithm developed in 2007 was the QRisk tool, designed to estimate cardiovascular risk over 10 years. Prior to this, the Framingham score, developed from a comparatively small cohort in the US, was used to assess cardiovascular risk in the UK and target high risk individuals for treatment. The original QRisk model has been updated to account for time trends and include additional risk factors. QRisk2 (reference 1) was published in 2008, and in 2017, we published a major update - QRisk3 ( www.qrisk.org/three/) (reference 2). QRisk3 is the first cardiovascular risk algorithm to include important risk factors such as serious mental illness, migraine, atypical antipsychotics, corticosteroids and blood pressure variability. A total of 981 general practices across England with 7.89 million patients were used to develop the QRisk3 model and 328 different practices with 2.67 million patients were used to validate the risk scores.
The overarching QPrediction set of risk tools comprises several other risk prediction tools including the following:
QStroke ( www.qstroke.org) . QStroke (reference 3) predicts 10-year absolute risk of stroke to identify high risk patients for whom stroke prevention measures, such as anticoagulation, are likely to be beneficial.
QFracture ( www.qfracture.org). QFracture was originally published in 2009 and was updated with additional predictor variables and an extended age range in 2012 (reference 4). It predicts the 10-year risk of having a fragility fracture of the hip, spine, wrist or shoulder so that high risk patients can have interventions to reduce this risk
QCancer ( www.qcancer.org). This estimates the risk of a patient having an existing but as yet undiagnosed cancer based on symptoms and risk factors for 12 different types of cancer in men and women (references 5, 6). The tool was developed to help GPs identify patients at increased risk of having cancer for referral for investigations, with the intention of aiding earlier diagnosis. Separate cancer risk scores have been developed to estimate cancer risks over 10 years (reference 7).
QDiabetes ( www.qdiabetes.org). The first QDiabetes model was published in 2009, and a new version incorporating additional predictor variables and blood test results was published in 2017 (reference 8). It predicts the 10 year risk of developing type 2 diabetes so that high risk patients can receive interventions to lower their risk.
QAdmissions ( www.qadmissions.org) identifies patients at high risk of unplanned hospital admission so that care packages can be put in place to reduce hospital admissions (reference 9).
QRisk lifetime ( https://qrisk.org/lifetime/) predicts lifetime risk of developing cardiovascular disease to help inform prevention strategies and lifestyle changes (reference 10).
3. References to the research
Key publications for some of the individual algorithms are:
Hippisley-Cox J, Coupland C, Vinogradova Y, Robson J, Minhas R, Sheikh A, Brindle P. Predicting cardiovascular risk in England and Wales: prospective derivation and validation of QRISK2. BMJ 2008; 336:1475. DOI: 10.1136/bmj.39609.449676.25
Hippisley-Cox J, Coupland C, Brindle P. Development and validation of QRISK3 risk prediction algorithms to estimate future risk of cardiovascular disease: prospective cohort study. BMJ 2017;357:j2099. DOI: 10.1136/bmj.j2099
Hippisley-Cox J, Coupland C, Brindle P. Derivation and validation of QStroke score for predicting risk of ischaemic stroke in primary care and comparison with other risk scores: a prospective open cohort study. BMJ 2013;346:f2573. DOI: 10.1136/bmj.f2573 4. Hippisley-Cox J, Coupland C. Derivation and validation of updated QFracture algorithm to predict risk of osteoporotic fracture in primary care in the United Kingdom: prospective open cohort study. BMJ 2012;344:e3427. DOI: 10.1136/bmj.e3427
Hippisley-Cox J, Coupland C. Symptoms and risk factors to identify men with suspected cancer in primary care: derivation and validation of an algorithm. British Journal of General Practice 2013;63:e1-e10. DOI: 10.3399/bjgp13X660724
Hippisley-Cox J, Coupland C. Symptoms and risk factors to identify women with suspected cancer in primary care: derivation and validation of an algorithm. British Journal of General Practice 2013;63:e11-e21. DOI: 10.3399/bjgp13X660733
Hippisley-Cox J, Coupland C. Development and validation of risk prediction algorithms to estimate future risk of common cancers in men and women: prospective cohort study. BMJ Open 2015;5:e007825. DOI: 10.1136/bmjopen-2015-007825
Hippisley-Cox J, Coupland C. Development and validation of QDiabetes-2018 risk prediction algorithm to estimate future risk of type 2 diabetes: cohort study. BMJ 2017;359:j5019. DOI: 10.1136/bmj.j5019
Hippisley-Cox J, Coupland C. Predicting risk of emergency admission to hospital using primary care data: derivation and validation of QAdmissions score. BMJ Open 2013;3:e003482. DOI: 10.1136/bmjopen-2013-003482
Hippisley-Cox J, Coupland C, Robson J, Brindle PM. Derivation, validation and evaluation of a new QRISK model to estimate lifetime risk of cardiovascular disease: cohort study using QResearch database. BMJ 2010;341:c6624 DOI: 10.1136/bmj.c6624
Awards
Publication 2 above was awarded RCGP research paper of the year 2017 (Category 2: CVD, Renal, Respiratory, Oral, ENT & Ophthalmology). https://bjgp.org/content/68/676/536
4. Details of the impact
National health policy and use in clinical practice
Inclusion in national guidelines
Several of the tools have been recommended for use in clinical practice in NICE guidance (Source 1). In 2014 QRisk2 was recommended as the sole risk tool of choice to assess cardiovascular disease risk in the NICE Cardiovascular disease guideline [CG181, 2014] (Source 1.1). New recommendations in the updated NICE guideline on hypertension in adults [NG136, 2019] (Source 1.2) include use of QRisk scores to inform antihypertensive treatment.
QDiabetes is recommended in NICE guidance (Source 1.3) on the prevention of type 2 diabetes [PH38, 2017]. The 2016 NICE guideline on multimorbidity [NG56, 2016] recommends using QAdmissions to identify adults with multimorbidity who are at risk of adverse events such as unplanned hospital admission or admission to care homes (Source 1.4). Other recommendations in guidelines include QFracture in NICE guidance [CG146, 2017] (Source 1.5) and the Scottish Intercollegiate Guideline Network (SIGN) national clinical guideline on osteoporosis management [SIGN 142; 2015] which has a key recommendation that to quantify fracture risk “ Fracture-risk assessment should be carried out, preferably using QFracture”. This assessment is then used to target pharmacological, and non-pharmacological treatments to reduce fracture risk (Source 2).
Implementation into clinical computer systems
All of the tools are publicly accessible, and most including QRisk2, QDiabetes, QFracture, QCancer, QStroke and QAdmissions have been integrated into the major UK GP clinical system (EMIS) (Source 3.1) which supplies computer systems to over 55% of GP practices in England, covering a population in excess of 30,000,000 people (Source 3.2).
The tools are also available as free open-source software (see links in section 2) to facilitate transparency, further research and use internationally. Google analytics show that since 2014, there have been over 2,000,000 hits to the QPrediction websites, with hits from most countries worldwide (Source 4).
Some tools have also been implemented in other GP clinical systems and by other suppliers including occupational health, pharmacy, secondary care and the private sector. For example, Wellpoint health kiosks which use QRisk3 are currently deployed in many occupational settings throughout the UK including the Ministry of Defence, Department of Health, DVLA, Kent County Council, Scottish Power, Scottish Water (Source 5).
Use and recommendations in clinical practice
QRisk is integral to policy guidance and practice such as currently being used in NHS Health checks, a national programme offering health checks to adults in England aged 40 to 74 (Source 6). It is designed to help prevent and detect early signs of heart disease, kidney disease, Type 2 diabetes and dementia and incorporates assessment of cardiovascular disease risk. Over 6,000,000 people in England received an NHS Health check between 2013 and 2017 (Source 6, p5).
The QRisk lifetime version of the tool is used by Public Health England on its NHS One You website (Source 7) to estimate heart age, with the aim of increasing awareness of heart health and acting as an incentive to make simple lifestyle changes. This was widely publicised by Public Health England in September 2018 . By June 2017 the website had been viewed by approximately 2,900,000 people, with approximately 1,200,000 completions of the tool (Source 8).
QCancer is designed to prompt GPs to think about diagnosis of cancer and refer high risk patients to hospital sooner, with the aim of patients being diagnosed at an earlier stage when there are more treatment options likely to improve survival. The QCancer tool is recommended by Cancer Research UK, and its use is being facilitated by Macmillan which has successfully piloted the tool and is promoting its use as a cancer decision support tool in clinical practice across the country (Source 9).
Evaluations and evidence of benefits
In the NHS Health Check prevention programme in England people with a 10-year QRisk score of 10% or more are considered to be high risk of cardiovascular disease and are offered lifestyle advice, behaviour change support and considered for statin treatment. A microsimulation study by researchers at the University of Cambridge (Source 10) estimated that in England each year the programme is preventing approximately 300 premature deaths (before age 80) and resulting in an additional 1,000 people being free of cardiovascular disease, dementia, and lung cancer at age 80 years. The study also found that the programme has a greater absolute impact on health for people living in the most deprived areas, accordingly the programme as a whole is reducing health inequalities.
An independent study in the Lancet (Source 11) compared four strategies for determining eligibility for blood pressure treatment, including one based solely on blood pressure values, two strategies based on NICE hypertension guidelines (2011 and 2019) which consider a combination of QRisk2 scores, blood pressure measurements and medical conditions, and one based on using a threshold for QRisk2 scores alone. The study estimated that 322,921 cardiovascular events would be avoided in the UK over 10 years using QRisk2 scores alone to determine eligibility for blood pressure-lowering treatment compared with 233,152 events based on the 2011 NICE guideline, and 270,233 for the 2019 NICE guideline. It concluded that a risk-based strategy using QRisk2 scores was the most efficient strategy, and could prevent over a third more cardiovascular disease events than the 2011 NICE guideline and a fifth more than the 2019 NICE guideline.
A Public Health England feasibility review in 2016 of tools for identifying people at high risk of developing diabetes in NHS Health Checks found QDiabetes to be more accurate than the method used in NHS Health Checks at the time based on body mass index and blood pressure (Source 12). For example, the sensitivity was 66% using QDiabetes compared with 57% (Source 12, p6). QDiabetes is now one of the validated risk assessment tools for diabetes included in the NHS Health Check programme (Source 6).
An international guideline panel has proposed using QCancer colorectal cancer scores to identify people with increased risk (15-year risk above 3%) for colorectal cancer screening rather than a strategy of screening all people aged 50 to 79 years (Source 13). This recommendation was based on a modelling study and a linked systematic review of the benefits, harms, and burdens of colorectal screening. The modelling study predicted that in people with a QCancer risk score of 3% an estimated 5 to 6 colorectal cancer deaths would be prevented over 15 years per 1000 people screened. The panel proposed QCancer as it is “ one of the best performing models for both men and women”, and because it has been externally validated, has good calibration, is available as on online calculator and can predict risk over a 15-year time horizon (Source 13, p13).
5. Sources to corroborate the impact
S1 Inclusion of tools in NICE guidance (grouped source of evidence). Includes:
S1.1 Clinical guideline [CG181, 2014] pages 7, 10, 19, 20, 28, 33, 38;
S1.2 NICE guideline [NG136, 2019] pages 8, 26;
S1.3 NICE public health guideline [PH38, 2017] page 35;
S1.4 NICE guideline [NG56, 2016] pages 6, 23;
S1.5 Clinical guideline [CG146, 2017] pages 5, 7, 9-12.
S2 Scottish Intercollegiate Guidelines Network (SIGN). Management of osteoporosis and the prevention of fragility fractures. A national clinical guideline. Edinburgh: SIGN publication no. 142; first published March 2015, revised edition published June 2020. [Pages 5, 14, 25, 32-35, 37, 102, 116, 117, 122, 125]. Weblink
S3 S3.1 EMIS clinical calculators - clinical calculators integrated with EMIS Web
S3.2 Kontopantelis E, et al. Spatial distribution of clinical computer systems in primary care in England in 2016 and implications for primary care electronic medical record databases: a cross-sectional population study. BMJ Open 2018;8:e020738. [Page 3]. Weblink
S4 Analytics for hits on QPrediction tool websites. [Pages 1-4 in pdf].
S5 Wellpoint health kiosks. Weblink
Select CVD risk tab and Heart Age tab to see screens showing QRisk3 is used.
Scroll down to see Clients. [Pages 3-5, 9 in pdf].
S6 NHS Health Check Best practice guidance. Public Health England, October 2017. [Pages 5, 6, 17, 18, 21, 25, 43, 72]. Weblink
S7 Heart age tool. Weblink
For details showing QRisk2 – click on “Find out more about our partners and this tool”, see sections on “NHS Heart Age” and “Risk Model”. [Pages 3 and 4 in pdf].
S8 Public Health England. Action plan for cardiovascular disease prevention, 2017 to 2018. London: Public Health England, 2017. [Pages 5, 13, 14 in pdf]. Weblink
S9 The Macmillan Cancer Decision Support (CDS) tool. [Pages 3, 6-11, 13 in pdf].
S10 Mytton OT, et al. The current and potential health benefits of the National Health Service Health Check cardiovascular disease prevention programme in England: a microsimulation study. PLoS Med 2018; 15: e1002517. DOI: 10.1371/journal.pmed.1002517 [Pages 5-11, 23, 24, 30]. Weblink
S11 Herrett E, et al. Eligibility and subsequent burden of cardiovascular disease of four strategies for blood pressure-lowering treatment: a retrospective cohort study. Lancet 2019;394:663-71. DOI: 10.1016/S0140-6736(19)31359-5. [Pages 663-671]. Weblink
S12 NHS Health Check: Diabetes Filter Consultation. Public Health England. Published: London, September 2016. [Pages 5-11, 13-15 in pdf]. Weblink
S13 Helsingen LM, et al. Colorectal cancer screening with faecal immunochemical testing, sigmoidoscopy or colonoscopy: a clinical practice guideline. BMJ 2019; 367: l5515
DOI: 10.1136/bmj.l5515 [Pages 2, 13, 16]. Weblink
- Submitting institution
- University of Nottingham, The
- Unit of assessment
- 2 - Public Health, Health Services and Primary Care
- Summary impact type
- Health
- Is this case study continued from a case study submitted in 2014?
- No
1. Summary of the impact
Our tobacco control research has contributed to significant reductions in United Kingdom (UK) smoking prevalence and consequent mortality and morbidity, by changing national tobacco control policy and the delivery of stop smoking services. Between 2014 and 2018 there was a decrease from 18% to 15% in smoking prevalence. Our work has underpinned the establishment of the UK as a world leader in using electronic cigarettes for tobacco harm reduction; developed national models for smoking cessation support in pregnancy and in secondary care services; caused English prisons to go smoke-free; enabled legislation prohibiting smoking in cars carrying children; and supported national policy on standardised packaging and preventing media imagery that encourages smoking uptake and continuation, particularly amongst young people.
2. Underpinning research
Original research including systematic reviews, meta-analyses, randomised controlled trials (RCTs), surveys, observational studies and policy development has been a core activity during this REF period, and particularly since 2008 through Britton’s leadership of the UK Centre for Tobacco and Alcohol Studies (UKCTAS), one of five UK Clinical Research Collaboration (UKCRC) Public Health Research Centres of Excellence.
Evidence reviews and RCTs: Britton chaired the Royal College of Physicians (RCP) Tobacco Advisory Group (1996-2018) and commissioned, edited and led Nottingham UKCTAS staff in the production of substantive policy reports including primary research, systematic reviews and meta-analyses, and policy translation. These quantified the burden of passive smoking among children in the UK1i; revealed the extent of the health and economic impact of smoking among individuals with a mental health condition1ii; provided an update on the evidence about the use of e-cigarettes and concluded that promoting e-cigarettes as a substitute for smoking was likely to lead to substantial health gains in the UK 1iii; and demonstrated the harms and costs across the National Health Service (NHS) arising from smoking in NHS patients, setting out an approach for the systematic delivery of smoking cessation interventions within routine care1iv. Based on their collective findings, these recommended diverse policy changes related to passive smoking, mental health, tobacco harm reduction and integrating smoking cessation treatments into routine NHS care.1 Our landmark RCT of Nicotine Replacement Therapy (NRT) in pregnancy (SNAP)2 and related Cochrane Review,3 provided the first conclusive evidence that NRT helps pregnant women stop smoking. Another systematic review demonstrated the strong relationship between stillbirth and smoking in pregnancy.4 We completed the first reported RCT of opt-out smoking cessation service provision for hospital in-patients5 and a non-randomised study of delivering opt-out cessation provision in pregnancy,6 both demonstrating that systematically delivered opt-out referral models double service uptake and quit rates.
Mixed-methods intervention development: We produced the UK’s first cessation practitioners’ consensus on which behavioural techniques can best help pregnant women to stop smoking.7
Research to inform and evaluate policy: With the National Offender Management Service (NOMS), in the first study of its kind, we showed that in English prisons, prisoner and staff exposure to second-hand tobacco smoke was extremely high.8 We have also documented and publicised breaches of UK tobacco and alcohol advertising regulations, by highlighting examples of delivery of tobacco and alcohol imagery to children and young adults, through product use and brand placement in UK broadcast and other media.9,10
3. References to the research
*(University of Nottingham UoA2 researchers in bold)*
Royal College of Physicians reports: i) *Passive smoking and children (*2010, ISBN 978-1-86016-376-0); ii) Smoking and mental health (2013, ISBN 978-1-86016-508-5); iii) Nicotine without smoke - tobacco harm reduction (2016, ISBN 978-1-86016-600-6); iv) Hiding in plain sight: Treating tobacco dependency in the NHS (2018, ISBN 978-1-86016-731-7). https://www.rcplondon.ac.uk ( Britton J, Bogdanovica I, Coleman T, Huang Y, Hubbard RB, Leonardi-Bee J, Lewis S, McKeever TM, Murray RL, Langley TE, Szatkowski L, Tata LJ)
Coleman T, Cooper S, Thornton JG, Grainge MJ, Watts K , Britton J & Lewis S, for the SNAP Trial Team. A randomized trial of nicotine replacement therapy patches in pregnancy. New England Journal of Medicine, 2012; 366(9):808-18. DOI: 10.1056/NEJMoa1109582
Coleman T, Chamberlain C, Davey M-A, Cooper SE, Leonardi-Bee J. Pharmacological interventions for promoting smoking cessation during pregnancy. Cochrane Database of Systematic Reviews. 2015(12):CD010078. https://doi.org/10.1002/14651858.CD010078.pub2
NB: This citation is used to refer to all previous versions of this review; the first was published in 2012.
Marufu TC, Ahankari A, Coleman T, Lewis S. Maternal smoking and the risk of still birth: systematic review and meta-analysis. BMC Public Health, 2015;15:239. DOI:10.1186/s12889-015-1552-5
Murray RL, Leonardi-Bee J, Marsh J, Jayes L, Li J, Parrott S, and Britton J. Systematic identification and treatment of smokers by hospital based cessation practitioners in a secondary care setting: cluster randomised controlled trial. BMJ, 2013; 347: f4004. DOI: 10.1136/bmj.f4004
Campbell KA, Cooper S, Fahy SJ, Bowker K, Leonardi-Bee J, McEwen A, Whitemore R, Coleman T. 'Opt-out' referrals after identifying pregnant smokers using exhaled air carbon monoxide: impact on engagement with smoking cessation support. Tobacco Control, 2017;26:300-6. DOI: 10.1136/tobaccocontrol-2015-052662
Fergie L, Cooper S, Ussher M **, Campbell K, Coleman T . Stop smoking practitioner consensus on barriers and facilitators to smoking cessation in pregnancy and how to address these: A modified Delphi survey.* Addictive Behaviors Reports, 2019; 29;9:100164. https://doi.org/10.1016/j.abrep.2019.100164
Jayes LR, Ratschen E, Murray RL, Dymond-White S, and Britton J. Second-hand smoke in four English prisons: an air quality monitoring study. BMC Public Health, 2016; 16: 1-8. DOI: 10.1186/s12889-016-2757-y
Cranwell J, Murray R, Lewis S, Leonardi-Bee J, Dockrell M and Britton J. Adolescents' exposure to tobacco and alcohol content in YouTube music videos. Addiction, 2015; 110(4), 703-711. DOI: 10.1111/add.12835
Barker AB, Opazo Breton M, Cranwell J, Britton J, and Murray RL. Population exposure to smoking and tobacco branding in the UK reality show ‘Love Island’. Tobacco Control, 2018; 27:709-711. DOI: 10.1136/tobaccocontrol-2017-054125
Grants
*UK Centre for Tobacco Control Studies . Britton et al . UKCRC . Sept 08–Aug 13 . £4,755,464
UK Centre for Tobacco and Alcohol Studies . Britton et al . UKCRC . MR/K023195/1 . Sept 13–Aug 18 . £4,324,095
Smoking: new approaches to the cessation service delivery, prevention of passive smoke exposure in children, and healthcare cost estimation . Britton et al . NIHR Programme Grant . RP-PG-0608-10020. Jan 10 – Jan 15 . £2,002,012
Improving the effectiveness and reach of NHS support for smoking cessation in pregnancy. Coleman et al. NIHR Programme Grant. RP-PG-0109-10020 Jan 11 – Jun 20. £1,909,060
4. Details of the impact
(Superscript=section 3 references, upper case letter=evidence source)
Smoking is the largest avoidable cause of death and disability in the UK, typically reducing life expectancy by ten years. Our work has contributed to a reduction in UK smoking prevalence (from 18% in 2014 to 15% in 2018, equivalent to around 2,000,000 fewer smokers in 2018) larger than in the USA and other rich countries, which has already helped to prevent thousands of premature deaths, cases of morbidity, hundreds of stillbirths and substantial NHS costs. Quitting smoking improves life expectancy, wellbeing, protects children and the unborn child, reduces poverty and improves productivity.
PATHWAYS TO IMPACT
We work closely on evidence translation with the Tobacco Advisory Group of the RCP; the National Institute for Health and Care Excellence (NICE) (Britton chair of PH48 Guideline Development Group 2011-13; Chair of Public Health Advisory Committee (PHAC) D 2013-16; member of PH45 Guideline Group and Quality Standards Committee); the Medicines and Healthcare products Regulatory Agency (MHRA), on e-cigarette safety (Britton member of expert working group 2019-20); on policy advocacy with Action on Smoking and Health (Britton a Board member since 2000) and with the National Centre for Smoking Cessation Training (NCSCT), co-producing research-informed clinician guidance and training.7 Dissemination also occurs through Public Health England (PHE) via their Tobacco Control Implementation Board (Britton chair since 2014).
IMPACT ON POLICY AND LEGISLATION
As described in detail below, and as acknowledged by PHE, our research in a range of policy areas has been extremely valuable in demonstrating policy effectiveness and hence ensuring both the adoption and maintenance of new policies. As described by the Tobacco Control Programme Lead for PHE “It is no exaggeration to say that [research at the University of Nottingham] has had a central role in shaping the tobacco control policy and practice changes promoted by Public Health England” [A]. These impacts include:
The 2017 Tobacco Control Plan for England [B] : This defines policies to reduce smoking prevalence in England and cites two RCP reports as evidence on harms to children, and on the need to help smokers with mental health problems to quit1.i,1.ii [B p10 & ref 31, p13 & ref 47]. It recommends screening for smoking in all women attending antenatal care with routine use of carbon monoxide monitors as part of a new NHS care bundle for reducing stillbirth [B p11], for which our work4 was underpinning evidence [H.1 p13 & ref 7]. It further recommends automatic provision of cessation support for women identified as smokers, requiring women to ‘opt-out,’ citing our work in justification6 [B p10 & ref 36, p30].
The 2019 NHS Long Term Plan [C]: This plan set out commitments for future NHS services and cited the 2018 RCP report, which demonstrated the impact of implementing tobacco dependency treatment in NHS services1.iv, with a statement that the recommended model will be adopted by the NHS [C p35 & ref 29] and thus influence future NHS tobacco dependency treatment. The Tobacco Control Programme Lead at PHE states that “The work of John Britton, who with other Nottingham colleagues led the publication of a series of systematic reviews and economic models supporting this approach in the 2018 Royal College of Physicians Hiding in Plain Sight1.iv report led directly to the adoption of this approach in the 2018 NHS Long Term Plan” [A]. From 2018, Britton advised senior NHS England staff on the design and costs of service provision [A].
Tobacco harm reduction: The use of electronic cigarettes to reduce tobacco-related harm through partial or complete substitution for smoking is controversial and has met strong opposition in the UK, USA, Australia, and other countries. However, the UK has adopted the internationally ground-breaking policy of promoting electronic cigarettes as a tobacco harm reduction strategy, a policy substantially underpinned by our research1.iii [A; D pp1, 4 & ref 2; E pp5, 7 & ref 4]. The Tobacco Control Programme Lead for PHE states that “The research and evidence synthesis carried out by the Nottingham group has been fundamental to the adoption and endorsement by PHE of vaping as a reduced harm substitute for smoking” [A]. The 2016 RCP report1.iii advocated promotion of electronic cigarettes to replace smoking and was quoted verbatim in the Introduction section of the 2018 House of Commons Science and Technology Committee report on e-cigarettes [E p5 & ref 4]. The UKCTAS submission to the Committee, led by Britton, which cites our research, commissioned by PHE and the RCP, was also quoted verbatim [E pp7, 18] and cited extensively throughout the report [E], which concluded, as our reports and submissions advocated, that e-cigarette use should be promoted as a harm reduction strategy. The UK is now a world leader in encouraging vaping instead of smoking and has seen greater annual reductions in smoking prevalence than the USA (where vaping is not medically endorsed) or Australia (where vaping nicotine is prohibited).
Smoking in English prisons: Our 2015 report on indoor air quality for the National Offender Management Service (NOMS) (which was subsequently published as a peer-reviewed article8), demonstrated high levels of tobacco smoke exposure in prisons. This led to NOMS commissioning an independent organisation to repeat and corroborate our findings and to cite both sources as evidence to justify English prisons becoming smoke free since March 2016 [A, F.1, F.2a, F.2b].
Legislation prohibiting smoking in cars carrying children: The 2010 RCP report Passive smoking in children1.i was cited by the Department of Health in their consultation on this legislation [G p4 & ref 2], which was enacted in 2015.
IMPACT ON NHS SMOKING CESSATION PRACTICE
NHS stillbirth care bundle: Our review of smoking in pregnancy and stillbirth risk4 was underpinning evidence for the 2016 introduction of ‘opt-out’ smoking cessation provision as routine within NHS antenatal care (as a core element of the ‘Saving Babies’ Lives Care Bundle’ for reducing stillbirth) [H.1 p13 & ref 7]. An independent ‘care bundle’ evaluation found that implementation across England resulted in a decrease of 20% in stillbirths per year (approximately 600 fewer) again citing our review [H.2 p34 & ref 17]. Our review was further cited as core rationale for reducing smoking in pregnancy in version two of the care bundle (2019), designed to reduce perinatal mortality [H.3 p24 & refs 25 & 27, p68].
Changes in guidelines on NRT use globally: In 2012, the World Health Organisation (WHO) asked us to share findings from our, then unpublished, Cochrane systematic review on NRT in pregnancy3 which we were conducting. This featured prominently in WHO Recommendations for the prevention and management of tobacco use and second-hand smoke exposure in pregnancy [I.1] which concluded there was insufficient evidence for recommending NRT in pregnancy and called for further research. We updated the review with new trials and showed NRT is effective (published 2015).3 The impact of this work continues; our updated review now justifies pregnant women’s NRT use in European guidelines as well as those from the United Kingdom, Australia, New Zealand and Canada [I.2-8]. In the UK, in 2015 before the updated review was finalised, influenced by efficacy data from our major NRT trial2, NICE proposed an update to UK guidance on NRT in pregnancy [I.9]; this update is ongoing (due 2021).
Design and delivery of smoking cessation support in secondary care settings: Service design and costing proposals for cessation services, summarised in the 2018 RCP report1.iv, drawing on our 2013 trial5 and similar models developed in Ottawa were cited in the 2018 NHS Long Term Plan [A, C p35 & ref 29]. Our work on provision of cessation services in mental health settings and the March 2013 RCP report Smoking and mental health1.ii were heavily cited in PHE implementation 2015 guidance for commissioners and providers of mental health services [J p7, refs 3&7]. Our Cochrane review of NRT in pregnancy3 and NRT trial2 feature prominently in two evidence reviews [K.1, K.2] for the Nov 2013 NICE guidance PH48 [K] and justify the recommendation to offer NRT to pregnant women who are unable to stop smoking with the aim of reducing cravings for cigarettes during hospital stays [K recommendation 6, p13].
NHS health professional training and development of the first Standard Treatment Programme tailored to pregnant women: Our impact on NHS training is detailed in the evidence letter from the Chief Executive of the National Centre for Smoking Cessation Training (NCSCT) [L.1]. Our consensus on how to support pregnant women to stop smoking7, produced in the Supporting Smokefree Pregnancies (SSP) project with the NCSCT, was used to formulate the first ever NHS Standard Treatment Programme (STP) for smoking in pregnancy [L.2] and to update NHS staff training for treating patients according to this [L.3]. NCSCT used emergent project findings to underpin the STP and changed 3 NHS online training packages and a face-to-face training course by incorporating key consensus recommendations7. Before being permitted to support pregnant smokers, UK health professionals must successfully complete NCSCT training modules or courses and follow the STP, hence, our work substantially underpins current NHS clinical practice. The Chief Executive of the NCSCT states “The SSP project findings have substantially helped the NCSCT to improve the quality of stop smoking support for pregnant women. […] the NCSCT guidance for standard treatments and interventions delivered to pregnant women have been significantly improved based on the evidence-base developed by the SSP project. […] the SSP project findings will continue to impact on pregnant women who are helped to stop smoking by the NHS for years to come.” Training modules were revised by November 2018; before then, 33,751 NHS professionals had completed these and, by October 2020 10,208 had completed new versions [L.1]. Similarly, prior to course curriculum changes around 1,500 health professionals completed interpersonal training courses and between November 2018 and October 2020, 390 have done so [L.1].
Awards/prizes
Britton listed in Health Services Journal top 100 clinical leaders for innovation, 2015
Coleman, 5-year Senior Investigator Award from National Institute for Health Research, 2017
5. Sources to corroborate the impact
A) PHE letter of support from Tobacco Control Programme Lead, Public Health England, 2020
B) Towards a Smokefree Generation: A Tobacco Control Plan for England. Department of Health, 2017
D) E-cigarettes: a new foundation for evidence-based policy and practice. Public Health England, 2015
E) House of Commons Science and Technology Committee Report on E-cigarettes, 2018
F) Letter from Prisons Minister Andrew Selous to Robert Neill MP, Chairman of the Justice Select Committee regarding smoking in prisons, 2015 (F.1) (Letter includes link to Air quality reports (F.2a), one of which is the ‘Nottingham AQM Report,’ our air quality monitoring study (F.2b)
G) Smoking in private vehicles carrying children: consultation doc. Department of Health, 2014
H.1) Saving Babies’ Lives - A care bundle for reducing stillbirth, 2016
H.2) Evaluation of the implementation of the Saving Babies’ Lives Care Bundle in early adopter NHS Trusts in England. University of Manchester, SPiRE and Tommy’s, 2018 and press release
H.3) Saving Babies’ Lives Version 2 - A care bundle for reducing perinatal mortality, 2019
I) International and national guidelines that include smoking cessation recommendations for NRT use in pregnancy, 2013-2018 (I.1-I.9 detailed within)
J) Smoking cessation in secure mental health settings: Guidance for commissioners. PHE, 2015
K) Smoking: acute, maternity and mental health services. Public health guideline PH48, 2013 ( K.1, K.2)
L.1) NCSCT Director Letter, 2020
L.2) NCSCT Standard Treatment Programme for Pregnant Women, 2019
L.3) NCSCT Supporting Smokefree Pregnancies (SSP) Project – Changes made to NCSCT online training modules, face-to-face courses and resources, 2018
M) Draft Standardised Packaging of Tobacco Products Regulations, 2015 N) News articles documenting the removal of smoking from ‘Love Island’, 2018 ( N.1 Huffington Post, N.2 The Guardian)
- Submitting institution
- University of Nottingham, The
- Unit of assessment
- 2 - Public Health, Health Services and Primary Care
- Summary impact type
- Health
- Is this case study continued from a case study submitted in 2014?
- No
1. Summary of the impact
University of Nottingham researchers developed PINCER, a pharmacist-led IT-based i ntervention to reduce clinically important medication errors in primary care, which has been proven to substantially reduce hazardous prescribing in its widespread implementation in general practices across England. PINCER is recommended in NICE guidance (2015) and included in 5 National Health Service (NHS) guidance documents. PINCER has extensive reach, having been rolled out to 39% of English general practices, covering 40% of England’s population. By December 2020: 2,032 health care professionals had been trained to deliver PINCER; 2,688 general practices in 104 Clinical Commissioning Groups (77% of CCGs) had implemented PINCER and 25,545,538 patient records had been searched for prescribing errors. Analysis of follow-up data from 1,060 practices that implemented the PINCER intervention (between December 2018 and March 2020) shows a decrease of 14% in the number of patients at risk of at least one medication error and a decrease of 26% in errors associated with gastrointestinal bleeding, a common cause of medication-related hospital admissions.
2. Underpinning research
Prescribing errors in general practice are an important and expensive preventable cause of safety incidents, illness, hospitalisations and deaths. This is a significant quality and safety issue that is widely relevant to all health care systems. To address this, we conducted a study to determine the prevalence and nature of prescribing and monitoring errors in general practices in England and found that prescribing errors were identified in 5% of prescription items, with 1 in 550 items containing a severe (potentially life threatening) error; this equates to approximately 2,000,000 serious prescribing errors in English general practices each year.1 A further study showed hazardous prescribing in general practices to be a contributory cause of around 1 in 25 hospital admissions,2 and a recent Department of Health and Social Care (DHSC) commissioned report into the prevalence and cost of medication errors estimated the annual hospital admission costs for primary care avoidable adverse drug events to be GBP83,700,000 resulting in 627 deaths in England each year
In a systematic review, we identified 12 drug groups which account for 80% of hospital admissions that are medication-related and preventable.2 We showed that three groups of drugs are responsible for over a third of these admissions; anticoagulants, antiplatelets and non-steroidal anti-inflammatory drugs (which all cause gastrointestinal (GI) bleeding). An important implication from this study is that reducing hazardous prescribing (medication errors) in general practice associated with specific groups of drugs could prevent most medication-related hospital admissions. Therefore, we developed a set of ‘prescribing safety indicators’3 to identify patients exposed to medication errors in general practice, and the PINCER intervention is designed to ameliorate risk from these errors.
Informed by the Medical Research Council's framework for complex interventions, we developed and tested a pharmacist-led, IT-based intervention to reduce medication error in primary care (PINCER). It involves searching GP clinical systems using computerised prescribing safety indicators to identify patients at risk from their prescriptions, and then acting to correct the problems with pharmacist support. Findings from our cluster-randomised controlled trial of 72 general practices,4,5 demonstrated that PINCER is an effective and cost-effective method for reducing a range of clinically important and commonly made medication errors in primary care. For example, at 6 months' follow-up, patients in the PINCER group were significantly less likely to have been prescribed an oral non-steroidal anti-inflammatory drug (NSAID) if they had a history of peptic ulcer without gastroprotection (Odds Ratio (OR): 0·58; 95% Confidence Interval (CI): 0·38–0·89), thereby reducing their risk of hospital admission with GI bleeding. Economic analysis suggested that PINCER had a 95% probability of being cost effective if the decision-maker's ceiling willingness to pay reached GBP75 per error avoided (at 6 months) or GPB85 per error avoided (at 12 months).
With funding obtained from The Health Foundation (through their Scaling Up Improvement Programme) and East Midlands Academic Health Science Network (AHSN), PINCER was “scaled up” to 370 (94%) general practices across 12 East Midlands CCGs between September 2015 and April 2017 using an updated set of 11 prescribing safety indicators.6 Findings from the evaluation of this rollout identified 22,105 instances of potentially hazardous prescribing in a patient population of 2,970,000 and demonstrated statistically significant reductions in the number of patients at risk of at least one medication error at six-months follow-up (OR: 0.83; CI: 0.81-0.86), particularly in relation to prescribing safety indicators associated with risk of GI bleeding (OR: 0.76; 95%CI: 0.73-0.79).7
3. References to the research
*(University of Nottingham UoA2 researchers in bold)*
Avery AJ, Ghaleb M, Barber N et al (including Armstrong SJ and Serumaga B). The prevalence and nature of prescribing and monitoring errors in English general practice: a retrospective case note review. BJGP 2013;63(11):543-553. https://doi.org/10.3399/bjgp13X670679
Howard RL, Avery AJ, Slavenburg S et al (including Royal S). Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol 2007;63(2):136-147. https://doi.org/10.1111/j.1365-2125.2006.02698.x
Spencer R, Bell B, Avery AJ et al. Identification of an updated set of prescribing-safety indicators for GPs. BJGP 2014; 64(621):e181-e190. https://doi.org/10.3399/bjgp14X677806
Avery AJ, Rodgers S, Cantrill JA et al (including Armstrong S). A pharmacist-led information technology intervention for medication errors (PINCER): A multicentre, cluster randomised, controlled trial and cost-effectiveness analysis. Lancet 2012;379(9823): 1310-1319. https://doi.org/10.1016/S0140-6736(11)61817-5
Elliott RA, Putman KD, Franklin M et al (including Rodgers S and Avery AJ). Cost effectiveness of a pharmacist-led information technology intervention for reducing rates of clinically important errors in medicines management in general practices (PINCER). PharmacoEconomics 2014; 32(6):1-18. https://doi.org/10.1007/s40273-014-0148-8
Stocks SJ, Kontopantelis E, Akbarov A et al (including Rodgers S and Avery AJ). Examining variations in prescribing safety in UK general practice: a cross-sectional study using the Clinical Practice Research Datalink. BMJ 2015;351:h5501. https://doi.org/10.1136/bmj.h5501
Rodgers S, Salema N, Waring J et al (including Armstrong S, Mehta R, Bell B and Avery T). Improving medication safety in general practices in the East Midlands through the PINCER intervention: Scaling Up PINCER. Report to the Health Foundation, August 2018. Available on request
Key Research Grants
Oliver K, Rodgers S, Panayiotidis T, Fensome L, Johnson J, Barrett J, Evans D. Scale up, replication and licensing of the PINCER intervention. Health Foundation Exploring Social Franchising and Licensing Programme. Amount awarded GBP145,000 (with additional funding of GBP120,000 awarded May 2019). Award period: February 2018 to January 2021.
Avery AJ, Elliott RA, Rodgers S et al. Avoiding patient harm through the application of prescribing safety indicators in English general practices (acronym: PRoTeCT). NIHR Programme Grant for Applied Research. Amount awarded GBP2,430,144. Award period: March 2017 to August 2021.
Siriwardena N, Avery AJ, Rodgers S et al. Improving prescribing safety in general practices in the East Midlands through the PINCER intervention. Health Foundation Scaling Up Improvement. Amount awarded GBP500,000 (with a further GBP250,000 awarded by East Midlands AHSN). Award period: March 2015 to August 2017.
Rodgers S, Avery AJ, Silcock N et al. (including Bell B, and Salema N). Preparing for a Phase IV implementation trial using PINCER methodology aimed at reducing the incidence of serious hospital admissions. NIHR Research Capability Funding to develop an NIHR Programme Grant for Applied Research, January 2014. Amount awarded GBP49,878. Award period: March 2014 to February 2015.
Rodgers S, Avery AJ, Elliott R et al (including Bell B). Modelling the cost effectiveness of prescribing safety indicators to identify those that are likely to be most cost-effective for inclusion in a rollout of the PINCER trial intervention. NIHR SPCR Round 7. Amount awarded GBP29,973. Award period: June 2013 to May 2014.
Rodgers S. Development of prescribing safety indicators and data extraction methods in UK general practice. NIHR SPCR Fellowship, June 2012. Amount awarded GBP243,600. Award period: October 2012 to September 2015.
4. Details of the impact
(E = evidence source)**
Summary: We have developed and tested a pharmacist-led IT-based i ntervention to reduce clinically important medication errors in primary care (PINCER). PINCER has been widely implemented in general practices across England with reductions in hazardous prescribing, particularly prescribing associated with increased risk of gastrointestinal bleeding. PINCER’s impact in making primary care prescribing safer for patients has been demonstrated in its rollout to 39% of general practices in England. Its expansion continues, maintaining comparable reductions in medication errors to the original research study,4 which we have managed to replicate at scale and pace.
a. Development of a PINCER replication model (E1): Since 2017, PRIMIS at the University of Nottingham ( https://www.nottingham.ac.uk/primis/) has been funded by the Health Foundation to work with Spring Impact ( https://www.springimpact.org/), a non-profit global leader in social replication, to implement their systematic five-stage process to design a replication model for the scale and spread of PINCER using a social franchising approach
( https://www.health.org.uk/funding-and-partnerships/programmes/exploring-social-franchising) (E1). Social franchising involves enabling another team or organisation to deliver a proven intervention to agreed standards under a franchise agreement, with the primary aim of maximising social benefit. As a result of this work, in 2018 PINCER was selected by the AHSN Network for national adoption and spread ( https://www.ahsnnetwork.com/about-academic-health-science-networks/national-programmes-priorities) whereby PRIMIS acts as “Franchisor” and the 15 AHSNs in England act as “Franchisees”.
b. Organisational and clinical impact of PINCER (E2-E7): As of 7 December 2020, the scale and scope of the national rollout of PINCER was as follows:
104 (77%) CCGs in England had participated (E2).
25,545,538 individual patient records had been searched to identify those at risk of medication error using 13 prescribing safety indicators (E3).
2,688 (39%) general practices had implemented PINCER and had uploaded anonymised aggregate baseline data to the PINCER CHART Online comparative analysis service (E3).
206,109 patients had been identified as being at risk of at least one medication error prior to PINCER implementation (baseline) giving an overall prevalence of 8.07 patients at risk of medication error per 1,000 registered patients (E3).
In terms of clinical impact (as documented in our PINCER progress report: E4), analysis of follow-up data over a 15-month period (between December 2018 and March 2020) relative to baseline from 1,060 practices showed (pp 4-5, 59-65; E4):
A decrease of 13,387 (14%) in the number of patients at risk of at least one medication error (92,762 patients at baseline; 79,375 patients at follow-up).
Greatest reductions for errors associated with GI bleeding, which showed a decrease of 10,559 (26%) patients (40,720 patients at baseline; 30,161 patients at follow-up).
Given that PINCER focuses on ameliorating some of the most important prescribing errors, it is likely (based on the evidence presented in section 2) that the intervention will have reduced medication-related hospital admissions and patient harm. Indeed, the Deputy Chief Pharmaceutical Officer for NHS England states: “I am in no doubt that PINCER will have prevented hospital admissions and patient harm in England” (E5).
One of the key strengths of the national rollout of PINCER has been the ability for general practices, pharmacists and named individuals at CCGs to access comparative views of numbers of at-risk patients using the PRIMIS CHART Online comparative analysis service, including time-trended analyses ( E6). Over time, as more and more practices have been participating in the national rollout of PINCER and uploading their summative data to CHART Online, the facility has been providing a national picture of medication safety thus enabling localities to prioritise areas for their own improvement as well as evaluating the impact of the PINCER implementation. For example, in Wessex AHSN, PINCER was implemented in 236 (94%) general practices. The Clinical Lead Medicines Optimisation (MO) with Wessex AHSN and Clinical Lead for National MO Programme says: “This has given us a robust baseline measure of medication safety but more importantly, when practices implemented the PINCER intervention, we had 3,441 fewer patients at risk from clinically significant medication errors compared to baseline” (E7).
c. Upskilling the primary care pharmacy workforce (E8): As part of the national rollout, PRIMIS has been providing a comprehensive training package to support pharmacists to deliver the PINCER intervention, based on the training materials developed as part of the PINCER trial.4 To date, a total of 2,032 health care professionals (1,505 primary care pharmacists, 153 primary care pharmacy technicians, 176 GPs, 48 practice managers and 150 CCG/other primary care staff) have been trained to deliver the PINCER intervention through a combination of eLearning tools, online resources, live webinars and face-to-face action learning set sessions (E8). To meet demand for training, we have developed a Train-the-Trainer model to enable 8 AHSN Training Partners and 5 University of Nottingham contracted Training Associates to deliver training on our behalf.
d. Integration of PINCER indicators into third party software solutions (E9): In response to findings from the evaluation of the Health Foundation Scaling Up PINCER project in the East Midlands,7 PRIMIS has produced system searches that are embedded within the major GP clinical systems used in England such as EMIS WEB and The Phoenix Partnership (TPP) SystmOne. PRIMIS has developed a process for other IT system providers to embed the national PINCER indicators in their computer software. As a result, the University of Nottingham has licensed the national PINCER prescribing safety indicators to 4 major third-party suppliers for the purposes of implementing the PINCER indicators via their own software (E9). For example, the PINCER prescribing indicators are now embedded in First Databank’s clinical decision support software ‘Optimise Rx’ to improve patient safety by alerting clinicians to potential medication error at the point of prescribing
( https://www.fdbhealth.co.uk/company/press-releases/2020-02-11-fdb-partner-with-primis). Optimise Rx software has been rolled out to over 4,000 general practices in England covering more than 38,000,000 patients ( https://www.fdbhealth.co.uk/solutions/optimiserx).
e. Incorporation of PINCER into national Medicines Optimisation policy and guidance (E10-E16): Since 2015, PINCER has been incorporated into the NICE ‘Medicines Optimisation Clinical Guideline’ published 04 March 2015 (pp13,15; E10). This means that general practices throughout the country are encouraged to use the intervention. In 2017, the World Health Organisation identified ‘Medication Without Harm’ as the theme for their third Global Patient Safety Challenge which aims to reduce severe avoidable medication-related harm by 50% globally in the next 5 years. In response to this challenge, the NHS Business Services Authority produced a Medication Safety Dashboard incorporating the PINCER indicators for GI bleed (p44; E11). The Dashboard links prescribing data in primary care to hospital admissions to help the NHS monitor and prevent errors.
In January 2019, NHS England published “Investment and evolution: A five-year framework for GP Contract Reform to implement the NHS Long Term Plan”. Prescribing safety was a new quality improvement (QI) domain in the contract, with practices incentivised to demonstrate continuous quality improvement in relation to prescribing safety. The Framework stated (pp22, 103, 106; E12) “the nationally-backed rollout of the pharmacist-led information technology intervention for medical errors (PINCER or equivalent) by the AHSNs” as 1 of 4 key areas for Quality Improvement. As highlighted in the 2019/20 GMC Contract Quality and Outcomes Framework (QOF) Guidance (p101; E13) practices were encouraged to engage AHSN support for PINCER implementation to improve prescribing safety and achieve the QOF points for this domain.
PINCER has also been identified as an evidence-based approach to reducing a range of medication errors as part of the mandatory quality improvement project in the new General Medical Services (GMS) Contract Wales: QI Framework 2019-20 (pp22-23; E14). In July 2019, the NHS Patient Safety Strategy (pp17, 51; E15) highlighted PINCER as one of its Medicines Safety Improvement Programmes to “support work to reduce prescribing error rates by 50%, improving safety and reducing costs” and stated that “AHSN-supported national roll-out will reach at least 40% of GP practices [in England] by 2020.” In September 2020, the Network Contract Directed Enhanced Service Structured Medication Reviews and Medicines Optimisation Guidance cited PINCER as “an evidence-based intervention that reduces the risk of harm from clinically significant medication errors” and highlighted PINCER as a tool to help clinicians to identify patients who would benefit most from receiving a Structured Medication Review (pp5,17; E16).
f. National awards (E17): In recognition of our work, the team was shortlisted from 800 teams across the NHS Midlands and East and selected as regional winner in “The Excellence in Primary Care Award” category of the 2018 NHS70 Parliamentary Awards ( E17.1). The team was also shortlisted for the HSJ Patient Safety Awards 2020 in the category of Patient Safety Team of the Year, recognising our “outstanding contribution to healthcare through the national rollout of PINCER” ( E17.2; p61; E17.3).
5. Sources to corroborate the impact
PINCER Replication Model Design Report (July 2018)
PRIMIS CHART Online Comparative Analysis Service (8 December 2020)
PINCER Baseline Summary Datasheet (7 December 2020)
PINCER Progress Report (July 2020) Weblink
Letter of support from Deputy Chief Pharmaceutical Officer for NHS England
PRIMIS CHART Online Time Trend Data
Letter of support from Clinical Lead Medicines Optimisation with Wessex AHSN
PINCER Training Delegates Summary Datasheet (8 December 2020)
PINCER Delivery Partners (7 December 2020)
NICE Medicines Optimisation Guidance (March 2015) Weblink
NHS Medication Safety Dashboard Indicators Specification (August 2019)
NHS England. Investment and evolution: A five-year framework for GP Contract Reform to implement the NHS Long Term Plan (January 2019) Weblink
NHS England. 2019/20 General Medical Services (GMS) contract Quality and Outcomes Framework (QOF) (April 2019) Weblink
Welsh Government. Quality Assurance and Improvement Framework Guidance for the GMS Contract Wales 2019/20 (September 2019) Weblink
The NHS Patient Safety Strategy (July 2019) Weblink
NHS England. Network Contract DES Structured Medication Reviews and Medicines Optimisation: Guidance (September 2020) Weblink
Evidence for PINCER National Awards
- Submitting institution
- University of Nottingham, The
- Unit of assessment
- 2 - Public Health, Health Services and Primary Care
- Summary impact type
- Societal
- Is this case study continued from a case study submitted in 2014?
- No
1. Summary of the impact
Hospital admissions for child home injuries in England decreased by 18% between 2013/14 and 2019/20 and our research played a major part in this reduction. A 17-year body of randomised controlled trials (RCTs), systematic reviews, meta-analyses and decision analyses by the Injury Epidemiology and Prevention Research Group at the University of Nottingham provides most of the evidence underpinning the introduction of UK home safety equipment schemes for preventing child unintentional (accidental) injuries. These schemes have been shown to significantly reduce hospital admission rates and have been provided by 43% of local authorities in England and Wales, nationally across Scotland and internationally. Our unique RCT and cost-effectiveness analysis of thermostatic mixer valves (TMVs) to prevent scalds, underpins their fitting in 400 social housing homes each year in Scotland. Our systematic reviews show home visiting programmes reduce child injuries, with programmes now delivered internationally to numerous families each year. Our research has made major contributions to national and international injury prevention strategies and guidelines on reducing child injuries and led to production of implementation resources, extensively used in the UK. Training based on our implementation resources has been provided to more than 550 health and social care practitioners across England, resulting in 90% of practitioners increasing knowledge, 87% increasing confidence and a demonstrated increase in home safety promotion following training.
2. Underpinning research
(Superscript=section 3 references, E=evidence source)
This case study is based on a 17-year body of work building the evidence base for the prevention of unintentional (accidental) injuries at home in the under-fives. Unintentional injury is a leading cause of child death in many countries including the UK. National data shows it results in an average of 55 deaths each year in the under-fives, approximately 40,000 hospital admissions and 370,000 emergency department attendances. Childhood injuries can result in long-term health, educational and social consequences and there are much higher rates of death and serious injury among children from the most deprived areas. Most unintentional injuries are preventable.
Five of our randomised controlled trials(e.g. 1,3) and 10 of our systematic reviews(e.g. 2,6) show home safety education and provision of safety equipment to families with children aged under 5 significantly improves uptake and use of home safety equipment (e.g. smoke alarms, stair gates, cupboard locks, socket covers) and home safety behaviours (e.g. safe storage of poisons, reducing hot water temperature, reducing use of hazardous nursery items such as baby walkers). Our network meta-analyses6 show that more intensive interventions (e.g. education, plus home safety assessment, provision and fitting of safety equipment) are the most effective in improving safety equipment uptake and use and home safety behaviours. Our decision analyses6 show interventions provided to disadvantaged families to reduce hot tap water temperature, promote smoke alarm use and safe storage of medicines are cost effective. Our unique RCT3,4 evaluating the effectiveness and cost-effectiveness of TMVs (devices to reduce hot tap water temperature and scald risk), demonstrated a significant reduction in hot water temperature, acceptability to families and a saving of GBP1.41 for every GBP1 spent. These findings provide much of the evidence underpinning home safety equipment schemes that are now widely implemented nationally and internationally.
We have also shown that improving uptake and use of safety equipment and safety behaviours reduced the burden of child injuries at a population level. Using a controlled interrupted time series analysis, we evaluated England’s national home safety equipment scheme showing a 12.1% reduction in hospital admissions for child injury in scheme areas compared to a 6.7% reduction in areas without the scheme (p=0.001 for difference in trends) over the 4 years after the scheme ended. (See our independent evaluation of the national scheme, E6). Importantly, our research also shows that, unlike many health promotion interventions, these interventions are not more effective amongst advantaged populations and are therefore unlikely to widen health inequalities2. Three of our systematic reviews(e.g. 5) also show other approaches are effective, e.g. parenting interventions and home visiting programmes improve home safety behaviours and reduce child injuries by 17%. These are multicomponent interventions aimed at improving a range of maternal and child health outcomes, including child injury. Such programmes are widely implemented nationally and internationally.
From 2009 to 2014 we received NIHR programme grant funding (GBP 2.1 million) for “Keeping children safe at home: a multicentre collaborative research programme to reduce childhood injuries”6. Outputs included evidence-based implementation tools ( Injury Prevention Briefing (IPB) (2014) and a Commissioners Guide (2016)).
3. References to the research
(University of Nottingham UOA2 researchers in bold)
Watson M, Kendrick D, Coupland C et al. Providing child safety equipment for the prevention of injuries: a randomised controlled trial. BMJ 2005; 330: 178-181. doi:10.1136/bmj.38309.664444.8F
Kendrick D, Young B, Mason-Jones AJ et al ( Coupland C is an author). Home safety education and provision of safety equipment for injury prevention. Cochrane Database of Systematic Reviews 2012, Issue 9. Art. No.: CD005014. doi: 10.1002/14651858.CD005014.pub3.
Kendrick D, Stewart J, Smith S et al. ( Coupland C is an author). Randomised controlled trial of thermostatic mixer valves in reducing bath hot tap water temperature in families with young children in social housing. Arch Dis Child 2011 Mar;96(3):232-9. doi:10.1136/adc.2009.175059
Phillips CJ, Humphreys I, Kendrick D et al ( Coupland C is an author). Preventing bath water scalds: a cost-effectiveness analysis of introducing bath thermostatic mixer valves in social housing. Inj Prev. 2011 Aug;17(4):238-43. doi:10.1136/ip.2010.031393
Kendrick D, Mulvaney CA, Ye L et al. Parenting interventions for the prevention of unintentional injuries in childhood. Cochrane Database Syst Rev. 2013 Mar 28;3:CD006020. doi:10.1002/14651858.CD006020.pub3.
Kendrick D, Ablewhite J, Achana F et al. ( Coupland C is an author). Keeping Children Safe: a multicentre programme of research to increase the evidence base for preventing unintentional injuries in the home in the under-fives. Southampton (UK): NIHR Journals Library; 2017 Jul. doi:10.3310/pgfar05140 (Lists 36 publications arising from Keeping Children Safe; see pp 358-361. These are all referenced with 6 in the text of section 4)
Grants: (Chief Investigator (ChI); Principal Investigator (PI))
a. National Institute for Health Research £2,124,754. Programme grant. “Keeping children safe at home: a multicentre collaborative research programme to reduce childhood injuries”. 2009-2014. Kendrick (ChI), Coupland (PI).
b. Department of Health £69,368. “Does the effect of home safety counselling or education with or without the provision of safety equipment differ between social groups? A systematic review and meta-analysis.” 2004–2005. Kendrick (ChI); Coupland (PI).
c. Department of Health £651,155. “Moving From Observation to Intervention” (2 RCTs evaluating interventions to reduce child injuries and a cohort study to measure the injury related disability. 2004-2008. Kendrick (ChI on one trial and PI on other studies), Coupland (PI).
d. NHS Executive Trent £145,047. “Randomised controlled trial of the effectiveness of health visitor advice plus access to a low cost safety equipment scheme in reducing unintentional injury in childhood.” 1999-2002. Kendrick (ChI), Coupland (PI).
e. NHS Executive Trent £102,864. “Cluster randomised controlled trial of the effectiveness of an educational package in reducing baby walker use.” 1999-2002. Kendrick (ChI).
f. NIHR School for Primary Care Research (NSPCR) £62,211. “Evaluation of the impact of the national ‘Safe At Home’ scheme on injury rates in children under 5 using secondary care data.” 2017–2019. Orton (ChI), Kendrick , Coupland (PIs)
g. Nottingham Citycare (Big Lottery funding) £225,126. “The Stay One Step Ahead Home Safety Project.” 2017–2021. Kendrick and Orton (Co-ChIs), Coupland (PI).
Awards: Kendrick (2001-2006): Department of Health. National Public Health Career Scientist Award (£480,100) for a 5-year research programme into inequalities in childhood unintentional injuries . Kendrick (2008): Royal Society for the Prevention of Accidents Distinguished Service Award for Academic Achievement for services to home safety.
4. Details of the impact
(Superscript=section 3 references, E=evidence source)
a. Influencing national policy on provision of home safety equipment (E1-5)
Our research on the effectiveness of home safety education and safety equipment provision had a major impact on recommendations about home safety assessment and safety equipment provision across several national policy documents (see below). Our 2015 survey shows wide use of these documents by local authorities: 75% using National Institute for Health and Care Excellence (NICE) PH29/30 and 57% using Public Health England (PHE) guidance in decision making about child injury prevention work.
The evidence underpinning NICE PH29/30 2010 was updated in 2015, citing 14 new papers(6), all from our research group ( E1 pp5-10). For example, our TMV study3 strengthened evidence supporting existing recommendations on their installation: “This study [reference 3] provides new evidence of specific interventions to prevent scalds in children. This evidence supports PH29 recommendation 9 and PH30 recommendation 3 on installation of TMVs in social and rented dwellings” ( E1 pg6).
Public Health England’s (PHE) 2018 local authority guidance “Reducing unintentional injuries in and around the home among children under five years” cites 14 of our papers2,6 and our implementation resources6 ( E2 pp4-7,13,14,18,19,26, 28-32), e.g. our Cochrane review demonstrating effectiveness2: “ Research [reference 2] shows that providing safety education and free or low-cost safety equipment is effective in improving home safety and can reduce inequalities in some home safety practices” ( E2 pg19).
The 2018 English National Accident Prevention Strategy cites 6 of our papers2,6 ( E3 pp15,19,26,27,59,60); e.g. our Cochrane review2: “E vidence [reference 2] has shown that the most effective interventions are those that provide education alongside home safety checks and the provision and fitting of various items of safety equipment in the home” ( E3 pg19). In addition, DK/EO were members of the National Accident Prevention Strategy Advisory Group. Our Cochrane review was also cited in NHS Health Scotland’s 2017 Unintentional injuries and home safety guidance2 ( E4 pp4,11). In 2013 the Chief Medical Officer ( E5 ch3 pp13,40; ch6 pp4,11) cited our research2,4 as evidence of effectiveness and cost-effectiveness of education and safety equipment provision, making a new policy recommendation for implementing home safety recommendations in NICE PH29/30.
b. Influencing national and international provision of home safety equipment (E6-9)
English Hospital Episode Statistics show a decrease of 18% in hospital admissions nationally for child home injuries between 2013/14 (unable to disaggregate; n=46,895) and 2019/20 (n=38,571). Home safety equipment schemes contributed substantially to this reduction, as shown by our independent evaluation of the national scheme which demonstrated a significant reduction in hospital admission rates following the scheme ( E6, pg 5). Our survey of local authorities shows these schemes are widely implemented, with 43% of local authorities in England and Wales having a scheme in 2015. Many schemes cite our research as underpinning evidence, e.g. the Scottish home safety equipment scheme. The Royal Society for the Prevention of Accidents (RoSPA) confirmed *“research carried out by Nottingham University on home safety education, home safety checks and home safety equipment provided much of the UK evidence on which the Scottish home safety equipment scheme was based.” ( E7.1)**. Between April 2013 and June 2014 (unable to disaggregate), 900 families benefitted from the scheme ( E7.2 pg23). A similar scheme in Ontario, Canada provided equipment to 3,458 families, from April 2013 to March 2015 (unable to disaggregate), resulting in a significant reduction in emergency department attendances for home injuries (p=0.01) ( E8 pp535-6). This ongoing programme was explicitly based on our Cochrane systematic reviews2,5: “interventions providing safety equipment seem to be more effective in improving some safety practices than those not doing so.[ references 2,5] Based on these findings…. we developed a home safety program*” ( E8 pp533,540). Our TMV trial3,4 was a research collaboration with Glasgow Housing Association (GHA), who subsequently fitted 24,000 homes with TMVs in 2011. GHA has been taken over by the Wheatley Group, who manage 93,7000 affordable homes in Scotland and have fitted TMVs in bathroom refurbishments in a further 1,929 homes between April 2015 and March 2020 ( E9).
c. Influencing international policy and provision of parenting and home visiting programmes (E10)
Our systematic reviews of parenting and home visiting interventions demonstrating significant reductions in child injuries5 provide evidence underpinning Israel’s injury prevention programme in 9 hospitals reaching more than 3,000 families between April 2013 and December 2014 (unable to disaggregate) ( E10.1 pp2,10, E10.2 p10), and Maternal, Infant, and Early Childhood Home Visiting Programs in the USA, e.g. 4,587 families in New Mexico in 2017 ( E10.3 pp1,24) and 1,184 families in Utah in 2016 ( E10.4 pg1; E10.5).
d. Informing national and international practitioner guides (E11,12)
Our research, Injury Prevention Briefing (IPB) and commissioners’ guide have informed home safety recommendations in international and national practitioner guides. DK made a substantial contribution to PHE’s 2017 “Preventing unintentional injuries: A guide for all staff working with children under five years” which cites 3 of our papers6 ( E11.1 pp3,17,19,20) as evidenced by the Child Accident Prevention Trust (CAPT) stating “Nottingham had extensive input into the evidence-based safety advice and safety messages, drawing on findings from the Keeping Children Safe Programme.[reference 6] Members of the Keeping Children Safe team also attended each of the four launch events, setting out the evidence base for the safety advice and safety messages in the guide. When we promoted the PHE guide in a recent CAPT e-bulletin, there were 428 unique views of the article by a range of professionals” ( E12).
Our research informed the Institute of Health Visiting Local Authority Child Public Health Briefing: The Health Visiting contribution to Child Accident Prevention in 2016 which cites 6 of our papers,2,6 ( E11.2 pp1-6) and the New Zealand’s Ministry of Health “Well Child Practitioner Handbook” in 2014 which cites our Cochrane parenting review5 as good evidence stating “ See Kendrick et al 2013 [reference 5] for good evidence that injury prevention activity reduces unintentional injury in children and can improve home safety” ( E11.3 pp151,155). Our research also informed the Canadian Injury Prevention Resource in 2015 which cites 6 of our papers1,5,6 ( E11.4 pp52,54,268,278,377,383,400,404,405,408) and the US Children’s Safety Network Resource Guide for Preventing Unintentional Medication Poisoning in Children in 2016 which cites 3 of our papers6 ( E11.5 pp5,6,9).
e. Informing international injury prevention strategies (E13)
Our research informed international strategies including Child Unintentional Deaths and Injuries in New Zealand and Prevention Strategies in 2015 which cites 4 of our papers2 ( E13.1 pp47,59,71,77,90-93); the New South Wales Child Safety Good Practice Guide: Good investments in unintentional child injury prevention and safety promotion in 2016 which cites 14 of our papers1,2,5 ( E13.2 pp23,41,42,44-46,48,52,53,55,60,61,114,116) and the European Child Safety Alliance’s Child Safety Reference Frameworks for evidence-based injury prevention strategies in 2014 which cites 5 of our papers2,5( E13.3 pp6-8,14,15).
f. Developing resources for practitioner use (E11.1, 12, 14)
As a result of our research6 we produced: (i) a 75-page IPB in 2014 for practitioners, including 11 evidence-based home safety activities for use with families, which has been endorsed by NICE; (ii) a 32-page guide for commissioners of children’s services in 2016 distributed to local authorities in England and health boards in Wales and by CAPT via targeted mailing to their subscribers; and (iii) evidence-based home safety checklists, monthly safety messages and safety sessions at Children’s Centres for families in disadvantaged areas in Nottingham: Between October 2017 and June 2020, 4,451 families completed checklists, 24,400 home safety messages were distributed, 440 families attended safety sessions and 950 received home safety visits from family mentors using our evidence-based resources ( E14).
The IPB and commissioners’ guide are extensively cited by PHE’s 2017 practitioner guide ( E11.1 pp19,20) and promoted by the Institute of Health Visiting where they are the first 2 resources on their accident prevention resources page and the commissioners’ guide is described as “the first of its kind”. Their usefulness is evidenced by CAPT stating in 2017: “ This has been Nottingham University’s strength: disseminating findings with clear implications for practice through a range of formats and channels, including working in partnership to extend the reach of your work” and “Our links with public health, health visiting and early years services… show that all three of the outputs mentioned above [IPB, commissioners guide and PHE practitioners guide] are useful to practitioners and commissioners, enabling them to easily integrate evidence-based approaches into their work. We continue to promote them as key resources to support child injury prevention in the UK” ( E12).
g. Training health and social care professionals (E14-16)
We developed and delivered child home safety training focussing on use of the IPB (resulting from6) for 550 health and social care practitioners and family mentors in 4 sites in England (Nottingham, Bristol, Newcastle, Norwich) between 2014 and 2020 ( E14-16). The 2015 Nottingham evaluation shows 90% of practitioners increased knowledge and 87% increased confidence in home safety promotion. Three months later, practitioners had used each of the 11 home safety activities with between 100 and 250 families and at least 96% of practitioners found each activity to be useful/very useful ( E15 pp3-5). The 2016 Bristol evaluation showed using the IPB enabled discussions with parents about home safety ( E16 pg6), e.g. *“nice easily adaptable activities and guidance which get parents to think about dangers through the eyes of a child” and “encouraging parents to be aware of child development…promoting parental observation and encouraging them to be one step ahead” and increased practitioner confidence, e.g. “it has filled me with confidence in advising parents and families on how to prevent injury/accidents”. Our IPB is also extensively cited in module 2 of the Institute of Health Visiting 2015 online accident prevention training package.
5. Sources to corroborate the impact
E1. NICE Guidance: PH 29 & 30 Evidence Review 2015
E2. PHE Guidance: Reducing Unintentional Injuries in the under 5s 2018
E3. RoSPA National Accident Prevention Strategy 2018
E4. NHS Scotland Guidance: Unintentional injuries 2017
E5. CMO Report. Prevention Pays - Our Children Deserve Better 2013
E6. Final Report National Equipment Scheme Evaluation 2020
E7. Letter from RoSPA 2017 (E7.1), Evaluation of Scotland’s Home Safety Equipment Scheme 2014 (E7.2)
E8. Stewart et al J Trauma Acute Care Surg 2016. doi: 10.1097/TA.0000000000001148
E9. Emails from Wheatley Group re TMVs 2017 to 2020
E10. List of international parenting and home visiting programmes (Israel, USA)
E11. List of national and international practitioner guides (UK, New Zealand, Canada, USA)
E12. Child Accident Prevention Trust letter 2017
E13. List of international injury prevention strategies (New Zealand, Australia, Europe)
E14. Nottingham CityCare Letter 2020
E15. Nottingham practitioner training evaluation report 2015
E16. Bristol practitioner training evaluation report 2016 weblink