National Health Service Costs Research Articles

‘New Medicine Service’: supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial

ObjectiveTo examine the effectiveness and cost-effectiveness of the community pharmacy New Medicine Service (NMS) at 26 weeks.MethodsPragmatic patient-level parallel randomised controlled trial in 46 English community pharmacies. 504 participants aged...

The Economic Burden of Patients with Eating Disorders to Healthcare Providers: A 27-Year Retrospective Record Linked Electronic Cohort Study

Background: 70 million people worldwide suffer from an eating disorder (ED) and long-term care is often needed. Patients are often young and vulnerable yet ambivalent about recovery. Without specific knowledge of the disease trajectory, patients with ED can evade detection, delaying time to diagnosis and treatment, and influencing long-term outcome and grossly underestimating treatment costs. Aim: The aim of this study was to estimate the healthcare economic burden from 1990 to 2017 of a cohort of patients with a diagnosis of an ED. Methods: The linkage and hosting of data were performed in the Secure Anonymised Information Linkage (SAIL) databank using a retrospective cohort study design. The SAIL databank is a large routine clinical database covering Wales. The data used was from the Patient Episode Database for Wales, Wales Demographics Service and Welsh General Practice datasets between 01/07/1990 and 30/06/2017, which are placed in SAIL by the Welsh National Health Service (NHS) and other data holders. Findings: Between 1990 and 2017, 15,558 individuals had an ED diagnosis. Patients with ED had large costs for inpatient admissions and GP contacts. Interpretation: Routine clinical data can be used effectively to quantify some burden of costs of a mental disorder beyond service use. ED incurred high NHS costs for GP contacts and inpatient admissions. The study included patients across the spectrum of severities, irrespective of whether they are known to specialist services. The scale of costs suggest that suffering from ED is likely to cost the NHS in areas well beyond what specific mental health service provision costs. We suggest that it may be cost-effective to invest in early intervention services that can help patients recover promptly from ED and potentially prevent high long-term costs of treatment and debility. Funding: Health and Care Research Wales (Grant HRA-15-1079). Declaration of Interest: All the authors have no competing interests to declare. Ethical Approval: The study design uses anonymised data and therefore the need for ethical approval and participant consent was waived by the approving IRB (Institutional Review Board), the UK National Health Service Research Ethics Committee. Instead, the SAIL Information Governance Review Panel (IGRP), which contains members from the UK National Health Service Research Ethics Committee, experts in information governance and members of the public, approved the study, IGRP 0487. This study was carried out in Swansea University.

Impact of the Manchester Glaucoma Enhanced Referral Scheme on NHS costs

ObjectivesGlaucoma filtering schemes such as the Manchester Glaucoma Enhanced Referral Scheme (GERS) aim to reduce the number of false positive cases referred to Hospital Eye Services. Such schemes can also...

Suspected adverse drug reactions (ADRs) trends in older Italianpatients: an analysis from the National Pharmacovigilance Network.

The clinical management of older populations is a social and clinical challenge. These subjects are more vulnerable to adverse drug reactions (ADRs) due to multi morbidity, polypharmacy, and physio-pathological changes. We performed a study using data from the National Network of Pharmacovigilance of Italy available from 2001 to 2012, which include all spontaneous reports of suspected ADRs. Our study showed that 29,036 reports of suspected ADRs were recorded in 2012. Those for patients aged ≥ 65years were 11,426 that correspond to a reporting rate of 923.6 reports per million inhabitants. On the contrary, the reporting rate for total population was of 489 reports per million inhabitants. The evaluation of level of severity showed that 37% of reports of suspected ADRs in patients aged ≥ 65years were serious compared to 30% in the general population. Furthermore, 27% of reports recorded for older patients showed that they required more hospitalization or long-term care in comparison with the 21% for the general population, with a relevant impact on National Health Service costs. These data suggest the need to optimize the clinical strategy for older patients due to the multiple factors that increase the susceptibility to ADRs. There is a high need to potentiate clinical trials on older patients to adopt new diagnostic-therapeutic pathways in real life.

Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE)—integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trial

IntroductionPersistent physical symptoms (PPS), also known as medically unexplained symptoms are associated with profound physical disability, psychological distress and high healthcare costs. England’s annual National Health Service costs of attempting...

Unplanned admissions for patients with myeloma in the UK: Low frequency but high costs

BackgroundMultiple myeloma (MM) is associated with high healthcare resource utilisation and increasing hospitalisation rates. The aim of this study was to characterise the hospital use by patients with MM in the English National Health Service (NHS). MethodsRoutinely-collected aggregate data about all NHS-funded hospital admissions of patients with MM were analysed. Data were obtained from the English Hospital Episodes Statistics on admissions between 1 April 2014 and 31 March 2018. ResultsA total of 754,345 admissions were reported over four years, equivalent to a mean of 188,586 admissions per year. Of the 41,845 patients admitted during this period, 42% were women and 58% men. From the total admissions, 90% were elective and 10% unplanned. Mean annual estimated costs over the period were £46 million for elective and £56 million for unplanned admissions. The number of elective admissions increased by 4.5% with costs increasing 1.5% per year; for unplanned admissions, these figures were 4.1% and 9.0%, respectively. ConclusionsMM is associated with a significant number of hospital admissions and NHS costs. The majority of the hospital admissions are elective, but the highest burden in terms of costs relates to unplanned admissions, with numbers increasing over time.

Cost-effectiveness of using an extensively hydrolyzed casein formula supplemented with Lactobacillus rhamnosus GG in managing IgE-mediated cow’s milk protein allergy in the UK

Objective: To estimate the cost-effectiveness of using an extensively hydrolyzed casein formula (eHCF) plus the probiotic Lactobacillus rhamnosus GG (eHCF plus LGG; Nutramigen* LGG®) compared to an eHCF alone as first-line dietary management for Immunoglobulin E (IgE)-mediated cow’s milk protein allergy (CMPA) in the UK.Methods: Decision modelling was undertaken to estimate the probability of IgE-mediated cow’s milk allergic infants being symptom free (i.e. not experiencing urticaria, eczema, asthma or rhinoconjunctivitis) and developing tolerance to cow’s milk by 5 years. The model also estimated the cost (at 2016/2017 prices) of healthcare resource use funded by the UK’s National Health Service (NHS) over 5 years after starting a formula, as well as the relative cost-effectiveness of the two dietary formulae.Results: At 5 years after the start of a formula the probability of being symptom free was estimated to be 0.97 and 0.76 among infants who were originally fed eHCF plus LGG and an eHCF alone, respectively. This encompassed the probability of children being asthma free at 5 years after the start of treatment, which was 0.99 and 0.91 in the eHCF plus LGG and eHCF alone groups, respectively. Additionally, the probability of acquiring tolerance to cow’s milk was estimated to be 0.94 and 0.66 among infants who were originally fed eHCF plus LGG and an eHCF alone, respectively. The estimated total healthcare cost over 5 years of initially feeding infants with eHCF plus LGG was less than that of feeding infants with an eHCF alone (£4229 versus £5136 per patient).Conclusions: First-line management of newly diagnosed infants with IgE-mediated CMPA with eHCF plus LGG instead of an eHCF alone improves outcome, releases healthcare resources for alternative use, reduces the NHS cost of patient management and thereby affords a cost-effective dietetic strategy to the NHS.

Excess winter mortality and morbidity before, during, and after the Great Recession: the Portuguese case.

Although winter mortality and morbidity are phenomena common to most European countries, their magnitude varies significantly from country to country. The geographical disparities among regions with similar climates are the result of several social, economic, demographic, and biological conditions that influence an individual's vulnerability to winter conditions. The impact of poor socioeconomic conditions may be of such magnitude that an economic recession may aggravate the seasonal mortality pattern. This paper aims to measure the seasonal winter mortality, morbidity, and their related costs during the Great Recession (2009-2012) in mainland Portugal and its Regional Health Administrations (RHAs) and to compare it with the periods preceding and following it. Monthly mortality and morbidity data were collected and clustered into three periods: Great Recession (2009-2012), Pre-Recession (2005-2008), and Post-Recession (2013-2016). The impact of seasonal winter mortality and morbidity during the Great Recession in Portugal and its Regional Health Administrations was measured through the assessment of age-standardized excess winter (EW) death and hospital admissions rate and index, expected life expectancy gains without EW deaths, EW rate of potential years of life lost, and EW rate of emergency hospital admission costs. Important increases of winter deaths and hospital admissions were identified, resulting in an important number of potential years of life lost (87years of life lost per 100,000 inhabitants in 2009-2012), life expectancy loss (1year in 2009-2012), and National Health Service costs with explicit temporal and spatial variations. These human and economic costs have decreased consistently during the analyzed periods, while no significant increase was found during the Great Recession. Despite its reduction, the winter excess morbidity and mortality highlight that Portugal still faces substantial challenges related to a highly vulnerable population, calling for investments in better social and health protection.

Costs and outcomes in evaluating management of unhealed surgical wounds in the community in clinical practice in the UK: a cohort study

ObjectiveTo evaluate the patient pathways and associated health outcomes, resource use and corresponding costs attributable to managing unhealed surgical wounds in clinical practice, from initial presentation in the community in...

Open randomised trial of the (Arabin) pessary to prevent preterm birth in twin pregnancy with health economics and acceptability: STOPPIT-2—a study protocol

IntroductionThe STOPPIT-2 study aims to determine the clinical utility of the Arabin cervical pessary in preventing preterm birth in women with a twin pregnancy and a short cervix, about which...

Elective Vs Non-Elective Hospital Admissions By Patients with Multiple Myeloma in England 2014 - 2018

Introduction: Multiple myeloma (MM) is associated with high healthcare resource utilisation. Better understanding of the hospital use by patients with MM is needed to plan future resource allocation to care for these patients. The aim of this study was to characterise the hospital use by patients with MM in the English National Health Service (NHS).Methods: Routinely-collected aggregate hospital admissions data from patients with MM were used from all 451 hospital trusts in the English NHS. This included elective and non-elective hospital admissions from April 1st 2014 to March 31st 2018. Patients were identified using the ICD-10 code for MM (C90.0) as either primary or secondary diagnosis. The number of admissions, number of patients, procedures, and total NHS hospital costs (based on Healthcare Resource Groups and NHS national tariff) were extracted alongside data to identify what percentage of the total NHS admissions are related to MM. Elective admissions were defined as admissions where the decision to admit preceded the time of the actual admission.Results: There were 754,345 admission records reported during the period of analysis from 17,555 women and 24,290 men. Of these, 675,400 (89%) were elective and 78,945 non-elective admissions. The total cost during the period analysed was £183,389,143 for elective and £227,650,088 for non-elective admissions. For elective admissions, 65% of the costs were for day-cases. Despite non-elective admissions constituting only 11% of all admissions, they accounted for 55% of the total hospitalisation costs. Over the period of analysis, elective admissions increased in average by 4.5% per year whilst the average yearly increase in costs was 1.5%; for non-elective hospitalisations, these figures were 4.1% and 9.0%, respectively (Figure). Of the total number of non-elective admissions over the study period, 58% were by men. Most of the procedures for elective admissions were related to chemotherapy and for non-elective ones the majority regarded radiology.While only 0.2% of all patients admitted to the NHS between April 2014 and March 2018 had a MM code, they accounted for 1% of all admission records and 0.5% of all inpatient NHS costs. During this period, patients with MM had on average 19 elective and 3 non-elective admissions per year, compared to 3 elective and 2 non-elective admissions per year per person for all patients admitted to the NHS.Conclusions: MM is associated with a large number of hospital admissions in the English NHS, relative to the low incidence of the disease. While the majority of the hospital admissions are elective, non-elective admissions accounted for the majority of costs. The impact of non-elective admissions should be included when assessing the economic burden of MM and the benefits from novel therapies. Further research is needed to understand the timing of non-elective admissions in the natural history of MM. DisclosuresRamasamy:Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Nador:Amgen: Research Funding. Kishore:Celgene: Honoraria; Takeda: Honoraria, Other: travel support. Rabin:Novartis: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Janssen: Consultancy, Other: Travel support, Speakers Bureau; Takeda: Consultancy, Other: Travel support , Speakers Bureau; Celgene: Speakers Bureau. Yong:Janssen: Honoraria, Speakers Bureau; Amgen: Honoraria, Research Funding, Speakers Bureau; Takeda: Speakers Bureau; Celgene: Honoraria. Ashcroft:Amgen: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau; Celgene Corporation: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Amaris Medical: Consultancy, Honoraria. Bowcock:Janssen: Honoraria; Takeda: Honoraria; Amgen: Honoraria; Takeda: Consultancy. Drayson:Abingdon Health: Equity Ownership, Membership on an entity's Board of Directors or advisory committees.

Gathering momentum for the way ahead: fifth report of the Lancet Standing Commission on Liver Disease in the UK

This report presents further evidence on the escalating alcohol consumption in the UK and the burden of liver disease associated with this major risk factor, as well as the effects on hospital and primary care. We reiterate the need for fiscal regulation by the UK Government if overall alcohol consumption is to be reduced sufficiently to improve health outcomes. We also draw attention to the effects of drastic cuts in public services for alcohol treatment, the repeated failures of voluntary agreements with the drinks industry, and the influence of the industry through its lobbying activities. We continue to press for reintroduction of the alcohol duty escalator, which was highly effective during the 5 years it was in place, and the introduction of minimum unit pricing in England, targeted at the heaviest drinkers. Results from the introduction of minimum unit pricing in Scotland, with results from Wales to follow, are likely to seriously expose the weakness of England's position. The increasing prevalence of obesity-related liver disease, the rising number of people diagnosed with type 2 diabetes and its complications, and increasing number of cases of end-stage liver disease and primary liver cancers from non-alcoholic fatty liver disease make apparent the need for an obesity strategy for adults. We also discuss the important effects of obesity and alcohol on disease progression, and the increased risk of the ten most common cancers (including breast and colon cancers). A new in-depth analysis of the UK National Health Service (NHS) and total societal costs shows the extraordinarily large expenditures that could be saved or redeployed elsewhere in the NHS. Excellent results have been reported for new antiviral drugs for hepatitis C virus infection, making elimination of chronic infection a real possibility ahead of the WHO 2030 target. However, the extent of unidentified cases remains a problem, and will also apply when new curative drugs for hepatitis B virus become available. We also describe efforts to improve standards of hospital care for liver disease with better understanding of current service deficiencies and a new accreditation process for hospitals providing liver services. New commissioning arrangements for primary and community care represent progress, in terms of effective screening of high-risk subjects and the early detection of liver disease.

Exploring the impact of public health teams on alcohol premises\xa0licensing in England and Scotland (ExILEnS):\xa0procotol for a mixed methods natural experiment evaluation

BackgroundRecent regulatory changes in the system by which premises are licensed to sell alcohol, have given health representatives a formal role in the process in England and Scotland. The degree to which local public health teams engage with this process varies by locality in both nations, which have different licensing regimes. This study aims to critically assess the impact on alcohol-related harms - and mechanisms - of public health stakeholders’ engagement in alcohol premises licensing from 2012 to 2018, comparing local areas with differing types and intensities of engagement, and examining practice in Scotland and England.MethodsThe study will recruit 20 local authority areas where public health stakeholders have actively engaged with the alcohol premises licensing system (the ‘intervention’) and match them to a group of 20 lower activity areas using genetic matching. Four work packages are included: (1) Structured interviews and documentary analysis will examine the type and level of intervention activity from 2012 to 2018, creating a novel composite measure of the intensity of such activity and will assess the local licensing system and potential confounding activities over the same period. In-depth interviews with public health, licensing, police and others will explore perceived mechanisms of change, acceptability, and impact. (2) Using longitudinal growth models and time series analyses, the study will evaluate the impact of high and low levels of activity on alcohol-related harms using routine data from baseline 2009 to 2018. (3) Intervention costs, estimated National Health Service cost savings and health gains will be evaluated using the Sheffield Alcohol Policy Model to estimate impact on alcohol consumption and health inequalities. (4) The study will engage public health teams to create a new theory of change for public health involvement in the licensing process using our data. We will share findings with local, national and international stakeholders.DiscussionThis interdisciplinary study examines, for the first time, whether and how public health stakeholders’ involvement in alcohol licensing impacts on alcohol harms. Using mixed methods and drawing on complex systems thinking, it will make an important contribution to an expanding literature evaluating interventions not suited to traditional epidemiological research.

Effects and costs of implementing predictive risk stratification in primary care: a randomised stepped wedge trial

AimWe evaluated the introduction of a predictive risk stratification model (PRISM) into primary care. Contemporaneously National Health Service (NHS) Wales introduced Quality and Outcomes Framework payments to general practices to...

Novel pharmacist-led intervention secures the minimally important difference (MID) in Asthma Control Test (ACT) score: better outcomes for patients and the healthcare provider

IntroductionA key priority in asthma management is achieving control. The Asthma Control Test (ACT) is a validated tool showing a numerical indicator which has the potential to provide a target...

Estimating the costs of air pollution to the National Health Service and social care: An assessment and forecast up to 2035.

BackgroundAir pollution damages health by promoting the onset of some non-communicable diseases (NCDs), putting additional strain on the National Health Service (NHS) and social care. This study quantifies the total health and related NHS and social care cost burden due to fine particulate matter (PM2.5) and nitrogen dioxide (NO2) in England.Method and findingsAir pollutant concentration surfaces from land use regression models and cost data from hospital admissions data and a literature review were fed into a microsimulation model, that was run from 2015 to 2035. Different scenarios were modelled: (1) baseline ‘no change’ scenario; (2) individuals’ pollutant exposure is reduced to natural (non-anthropogenic) levels to compute the disease cases attributable to PM2.5 and NO2; (3) PM2.5 and NO2 concentrations reduced by 1 μg/m3; and (4) NO2 annual European Union limit values reached (40 μg/m3). For the 18 years after baseline, the total cumulative cost to the NHS and social care is estimated at £5.37 billion for PM2.5 and NO2 combined, rising to £18.57 billion when costs for diseases for which there is less robust evidence are included. These costs are due to the cumulative incidence of air-pollution-related NCDs, such as 348,878 coronary heart disease cases estimated to be attributable to PM2.5 and 573,363 diabetes cases estimated to be attributable to NO2 by 2035. Findings from modelling studies are limited by the conceptual model, assumptions, and the availability and quality of input data.ConclusionsApproximately 2.5 million cases of NCDs attributable to air pollution are predicted by 2035 if PM2.5 and NO2 stay at current levels, making air pollution an important public health priority. In future work, the modelling framework should be updated to include multi-pollutant exposure–response functions, as well as to disaggregate results by socioeconomic status.

Cohort study evaluating pressure ulcer management in clinical practice in the UK following initial presentation in the community: costs and outcomes

ObjectivesThe aim of this study was to estimate the patterns of care and annual levels of healthcare resource use attributable to managing pressure ulcers (PUs) in clinical practice in the...

Cost-utility analysis of interventions to improve effectiveness of exercise therapy for adults with knee osteoarthritis: the BEEP trial.

ObjectivesEvidence regarding the cost-effectiveness of enhancing physical therapy exercise programmes in order to improve outcomes for patients with knee OA remains unclear. This study investigates the cost-effectiveness of two enhanced physical therapy interventions compared with usual physical therapy care (UC) for adults with knee OA.MethodsA trial-based cost–utility analysis of individually tailored exercise (ITE) or targeted exercise adherence (TEA) compared with UC was undertaken over a period of 18 months. Patient-level costs were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a base-case UK health-care perspective.ResultsThe UC group was associated with lower National Health Service (NHS) costs [ITE-UC: £273.30, 95% CI: £−62.10 to £562.60; TEA-UC: £141.80, 95% CI: £−135.60 to £408.10)] and slightly higher QALY gains (ITE-UC: −0.015, 95% CI: −0.057 to 0.026; TEA-UC: −0.003, 95% CI: −0.045 to 0.038). In the base case, UC was the most likely cost-effective option (probability <40% of ITE or TEA cost-effective at £20 000/QALY). Differences in total costs were attributable to intervention costs, number of visits to NHS consultants and knee surgery, which were higher in both ITE and TEA groups.ConclusionThis is the first economic evaluation comparing usual physical therapy care vs enhanced exercise interventions for knee OA that involves greater exercise individualization, supervision and progression or that focuses on exercise and physical activity adherence over the longer term. Our findings show that UC is likely to be the most cost-effective option.Trial registrationCurrent Controlled Trials ISRCTN 93634563.Trial protocolFull details of the trial protocol can be found in the Supplementary Appendix, available with the full text of this article at http://www.biomedcentral.com/1471-2474/15/254 doi: 10.1186/1471-2474-15-254

Supervised exercise training as an adjunct therapy for venous leg ulcers: a randomized controlled feasibility trial.

SummaryBackgroundVenous leg ulcers (VLUs) are typically painful and heal slowly. Compression therapy offers high healing rates; however, improvements are not usually sustained. Exercise is a low‐cost, low‐risk and effective strategy for improving physical and mental health. Little is known about the feasibility and efficacy of supervised exercise training used in combination with compression therapy patients with VLUs.ObjectivesTo assess the feasibility of a 12‐week supervised exercise programme as an adjunct therapy to compression in patients with VLUs.MethodsThis was a two‐centre, two‐arm, parallel‐group, randomized feasibility trial. Thirty‐nine patients with venous ulcers were recruited and randomized 1 : 1 either to exercise (three sessions weekly) plus compression therapy or compression only. Progress/success criteria included exercise attendance rate, loss to follow‐up and patient preference. Baseline assessments were repeated at 12 weeks, 6 months and 1 year, with healing rate and time, ulcer recurrence and infection incidents documented. Intervention and healthcare utilization costs were calculated. Qualitative data were collected to assess participants’ experiences.ResultsSeventy‐two per cent of the exercise group participants attended all scheduled exercise sessions. No serious adverse events and only two exercise‐related adverse events (both increased ulcer discharge) were reported. Loss to follow‐up was 5%. At 12 months, median ulcer healing time was lower in the exercise group (13 vs. 34·7 weeks). Mean National Health Service costs were £813·27 for the exercise and £2298·57 for the control group.ConclusionsThe feasibility and acceptability of both the supervised exercise programme in conjunction with compression therapy and the study procedures is supported.

Rationale and design of the SMaRT trial: A randomised, prospective, parallel, non-blinded, one-centre trial to evaluate the use of magnetic resonance imaging in acute setting in patients presenting with suspected scaphoid fracture.

Background Wrist injury is a common presentation to the Emergency Department in the United Kingdom. Among these injuries, the scaphoid is the most common fractured carpal bone. However, given the limited ability of conventional radiography to accurately diagnose a suspected scaphoid fracture on presentation, its diagnosis and management remain challenging. Despite the vast clinical evidence supporting the superior accuracy of magnetic resonance imaging, there is little to no evidence around the real-world clinical and economic impact of immediate magnetic resonance imaging in the management of suspected scaphoid fractures. Methods Review of design and implementation challenges associated with the identification and subsequent recruitment of eligible patients, implementation of a novel clinical pathway in an acute setting, rationale behind the primary and secondary outcomes selected and measurement of the primary outcome. Results The Scaphoid Magnetic Resonance Imaging in Trauma trial is a single-site prospective, randomised, non-blinded, parallel design trial that aims to evaluate the use of immediate magnetic resonance imaging in the management of patients presenting to the acute setting with suspected scaphoid fractures. The primary outcome is the total 3-month cost per patient associated with the diagnosis and treatment of suspected scaphoid fractures. It is hypothesised that the immediate use of magnetic resonance imaging, a more accurate but expensive imaging modality, in patients with negative findings in the initial four-view radiography, will reduce the overall National Health Service costs by promoting definitive care and avoiding unnecessary diagnostic and treatment procedures. Other rationale design considerations in the recruitment, randomisation, data acquisition and intervention implementation are also discussed. Several of these challenges derive from real-world operational issues associated with the provision of magnetic resonance imaging in an intrinsically complex acute setting. Staff engagement during the trial's planning phase, combined with an extensive training programme rolled out prior to the trial's launch, were essential to raise staff awareness and engagement. Given the acute nature of the clinical condition, the latter was deemed essential as the eligibility assessment, recruitment, randomisation and treatment allocation processes all need to happen in a very tight time frame. Limitations Findings from the Scaphoid Magnetic Resonance Imaging in Trauma trial might not be generalisable to other National Health Service hospitals, foreign healthcare systems nor patient presentations outside normal magnetic resonance imaging working hours. Conclusion The Scaphoid Magnetic Resonance Imaging in Trauma trial was designed to evaluate the costs, patient satisfaction and clinical outcomes around the management of suspected scaphoid fractures and ultimately provide solid evidence on which to base the United Kingdom and international clinical practice. This article discusses the steps considered in the design of this novel trial, with particular emphasis on the issues and lessons learned during the planning and implementation stages.