UK National Health Service Setting Research Articles

Subarachnoid haemorrhage in the emergency department (SHED): a prospective, observational, multicentre cohort study

BackgroundPeople presenting to the ED with acute severe headache often undergo investigation to exclude subarachnoid haemorrhage (SAH). International guidelines propose that brain imaging within 6 hours of headache onset can...

Prevention of postpartum haemorrhage: Economic evaluation of the novel butterfly device in a UK setting

ObjectivesTo explore the cost-effectiveness of a novel PPH device as compared with usual care. DesignA decision analytical model was used to explore the cost-effectiveness of the PPH Butterfly device compared with usual care. This was part of a United Kingdom, UK, clinical trial ISRCTN15452399 using a matched historical cohort who had standard PPH management without the use of the PPH Butterfly device. The economic evaluation was conducted from a UK National Health Service (NHS) perspective. SettingLiverpool Women’s Hospital, UK. Participants57 women with 113 matched controls. InterventionThe PPH Butterfly is a novel device that has been invented and developed in the UK to facilitate bimanual compression of the uterus in the treatment of PPH. Main outcome measuresMain outcome measures included healthcare costs, blood loss, and maternal morbidity events. ResultsMean treatment costs in the Butterfly cohort were £3,459.66 as compared with standard care £3,223.93. Treatment with the Butterfly device resulted in decreased total blood loss in comparison with standard care. The Butterfly device had an incremental cost-effectiveness ratio of £3,795.78 per PPH progression avoided (defined as ≤ 1000 ml additional blood loss from device insertion point). If the NHS is prepared to pay £8,500 per PPH progression avoided, then the Butterfly device is cost-effective with a probability of 87 percent. In the PPH Butterfly treatment arm there were 9% fewer cases of massive obstetric haemorrhage (severe PPH of more than 2000mls or more than 4 units of blood transfusion required) recorded as compared with the standard care historical cohort. As a low-cost device, the PPH Butterfly device is cost-effective but can be cost-saving to the NHS. ConclusionThe PPH pathway can result in high-cost resource use such as blood transfusion or high dependence unit hospital stays. The Butterfly device is a relative low-cost device in a UK NHS setting with a high probability of being cost-effective. The National Institute for Health and Care Excellence (NICE) can use this evidence in considering the adoption of innovative technologies such as the Butterfly device in the NHS. Extrapolation on an international scale to lower and middle-income countries could prevent mortality associated with PPH.

Understanding complexity in psychological services: A modified Delphi study.

The concept of patient or case complexity is relevant-and widely used-at all levels and stages of mental health service provision, but there have been few methodologically robust attempts to define this term. This study aimed to establish a consensus on factors contributing to patient complexity in adult psychological services using Delphi methodology. Applied psychologists in a single urban/suburban UK National Health Service setting took part in a three-round modified Delphi study. Twenty-eight respondents in Round 1gave qualitative data on factors they considered when assessing complexity, which was subject to thematic analysis. Twenty-five respondents in Round 2rated how central/peripheral each theme was to their judgement using Likert scales. In a third round, 20respondents addressed discrepancies and possible utilities of the emerging framework. Thirteen factors contributing to patient/case complexity (active severe/enduring mental health, current coping/functioning, engagement, forensic history, iatrogenic factors, interpersonal functioning, neurocognitive functioning, physical health, problematic substance use, risk, severity/chronicity of presenting problems, systemic and socioeconomic factors and trauma) were identified with a high degree of consensus. All were rated as central to complexity. We conclude that applied psychologists do have a shared understanding of complexity and make recommendations for further research validating, developing and applying this empirically derived framework.

Efficacy and safety data for the Ab interno XEN45 gel stent implant at 3 Years: A retrospective analysis.

To report efficacy and safety measures of the XEN45 gel stent at 36 months in the UK National Health Service setting. Retrospective non-comparative audit of the records of patients who underwent XEN45 implantation between June 2015 and May 2017 was performed. Main outcome measures were intraocular pressure and number of antihypertensive medications used. Failure was defined as need for further surgery or stent removal. Success was defined as a 20% decrease in intraocular pressure without the need for additional glaucoma medications or a reduction in antihypertensive medications without an increase in baseline intraocular pressure. Needling rates and preoperative factors effect were assessed. The cohort included 205 patients (205 eyes) with primary open angle glaucoma (84.4%), angle closure glaucoma (7.8%), or refractory glaucoma (7.8%), 62.9% had a stand-alone procedure and 37.1%, a combined phaco-XEN45 procedure. Mean intraocular pressure was 22.6 ± 7.0 mmHg at baseline compared to 14.7 ± 3.8 mmHg at 24 months and 14.0 ± 2.9 mmHg at 36 months (p < 0.001 for both). Mean number of medications used was 2.6 ± 1.1 at baseline compared to 0.5 ± 0.9 and 0.6 ± 1.0, at 24- and 36-months, respectively (p < 0.001 for both). The failure rate at 36 months was 25%. Needling was required in 36.6%. Evaluation of background factors yielded an increased failure rate in non-Caucasians compared to Caucasians (74% vs 21%, p < 0.001). XEN45 implantation is effective and safe at 36 months' follow-up. Patients should be advised regarding the risk of failure and possible need for bleb revisions. Careful patient selection may be required.

Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness

IntroductionBladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can...

The \u2018Better Conversations with Primary Progressive Aphasia (BCPPA)\u2019 program for people with PPA (Primary Progressive Aphasia): protocol for a randomised controlled pilot study

BackgroundPrimary progressive aphasia is a language-led dementia, often associated with frontotemporal dementia. It presents as insidious deterioration of language skills (e.g. naming objects and understanding complex sentences), with relative sparing of cognitive skills initially. There is little research examining the effectiveness of communication skills training for primary progressive aphasia, yet speech and language therapists (SLTs) report regularly using this in clinical practice. ‘Better Conversations with Primary Progressive Aphasia’ has potential to reduce barriers and increase facilitators to conversation and consequently improve confidence in communication and quality of life for people living with primary progressive aphasia and their conversation partners. The aim of this pilot study is to examine the feasibility of running a trial of the ‘Better Conversations with Primary Progressive Aphasia’ intervention.MethodsA single blind, randomised controlled pilot study will recruit 42 participants with primary progressive aphasia and their conversation partners across seven UK National Health Service Trusts. Participants will be randomised on a 1:1 basis, stratified by site, to receive either the ‘Better Conversations with Primary Progressive Aphasia’ intervention (21 couples) or no speech and language therapy treatment (21 couples). Participants are recruited by SLTs who will conduct pre-intervention assessment (week 1) and deliver the intervention (weeks 2 to 5). Junior researchers, who are blinded to allocation, will complete post-intervention measures (week 6). SLTs complete 9 h of training to prepare them to deliver the intervention. The primary objective of the study is to establish for a phase III effectiveness study whether the program can be delivered as intended in a UK National Health Service setting. Specifically, it will establish (1) the acceptability of randomisation, (2) an assessment of treatment fidelity to determine necessary levels of SLT training, (3) the most appropriate primary outcome measure, (4) sample size requirements, (5) predicted patient recruitment and retention rates and (6) refined inclusion criteria.DiscussionInsights from this study will be of relevance to guide development of future research and in particular, trials of therapeutic interventions in PPA, as well as for clinical care for this population.Trial registrationRetrospectively registered 28/02/2018 ISRCTN10148247

Discrepancies in central review re-testing of patients with ER-positive and HER2-negative breast cancer in the OPTIMA prelim randomised clinical trial

Background:There is limited data on results of central re-testing of samples from patients with invasive breast cancer categorised in their local hospital laboratories as oestrogen receptor (ER) positive and human epidermal growth factor receptor homologue 2 (HER2) negative.Methods:The Optimal Personalised Treatment of early breast cancer usIng Multiparameter Analysis preliminary study (OPTIMA prelim) was the feasibility phase of a randomised controlled trial to validate the use of multiparameter assay-directed chemotherapy decisions in the UK National Health Service (NHS). Eligibility criteria included ER positivity and HER2 negativity. Central re-testing of receptor status was mandatory.Results:Of the 431 patients tested centrally, discrepant results between central and local laboratory results were identified in only 19 (4.4%; 95% confidence interval 2.5–6.3%) patients (with 21 tumours). On central review, seven patients had cancers that were ER-negative (1.6%) and 13 (3.0%) patients with 15 tumours had HER2-positive disease, including one tumour discrepant for both biomarkers.Conclusions:Central re-testing of receptor status of invasive breast cancers in the UK NHS setting shows a high level of reproducibility in categorising tumours as ER-positive and HER2-negative, and raises questions regarding the cost effectiveness and clinical value of central re-testing in this sub-group of breast cancers in this setting.

Cost impact of a non-invasive, portable device for patient self-administration of chronic migraine in a UK National Health Service setting.

BackgroundChronic migraine (CM) is a neurological disorder associated with substantial disability. Botulinum toxin type A (Botox) is an approved and effective preventive treatment option for adult patients with CM. Transcranial magnetic stimulation (TMS) is an alternative treatment device delivering a brief pre-set magnetic pulse used for self-administration by the patient at home. Despite being available in a risk share scheme TMS is perceived to be more costly in the UK. The objective of this study was to analyse the incremental costs of TMS compared to Botox in refractory CM patients both for a UK individual funding request setting as well as for an average UK specialist center setting.MethodsCost impact results were derived from a decision-tree model simulating treatment pathways over 1 year. Costs were applied from the most recently available UK data sources. Sensitivity analysis was performed for all variables.ResultsBased on published utilisation data 45.5 % of CM patients would continuously receive Botox over 1 year, whereas 53.7 % of TMS patients would be still on treatment at the end of year one. Total costs of Botox treatment accrue to £2923 in an individual funding request NHS cost setting, whereas TMS treatment results in £1466 in the first year. Applying a time-based NHS cost setting expenditures accrue to £1747 for the Botox treatment and to £1361 for the TMS treatment. In both cost settings variation of cost assumptions did have a minor impact on the cost increment from Botox to TMS.ConclusionThe current risk share based remuneration model of TMS allows the UK NHS to reimburse only the cost of those patients experiencing reduction in migraine days resulting in lower costs for treating migraine attacks. Treatment of chronic refractory migraine using TMS implies a substantial cost reduction potential for the management of chronic treatment of refractory migraine patients compared to conventional Botox treatment.

Experiences with developing and implementing a virtual clinic for glaucoma care in an NHS setting.

BackgroundThis article describes the development of a virtual glaucoma clinic, whereby technicians collect information for remote review by a consultant specialist.Design and MethodsThis was a hospital-based service evaluation study. Patients suitable for the stable monitoring service (SMS) were low-risk patients with “suspect”, “early”-to-“moderate” glaucoma who were deemed stable by their consultant care team. Three technicians and one health care assistant ran the service. Patients underwent tests in a streamlined manner in a dedicated clinical facility, with virtual review of data by a consultant specialist through an electronic patient record.Main outcome measureFeasibility of developing a novel service within a UK National Health Service setting and improvement of patient journey time within the service were studied.ResultsChallenges to implementation of virtual clinic include staffing issues and use of information technology. Patient journey time within the SMS averaged 51 minutes, compared with 92 minutes in the glaucoma outpatient department. Patient satisfaction with the new service was high.ConclusionImplementing innovation into existing services of the National Health Service is challenging. However, the virtual clinic showed an improved patient journey time compared with that experienced within the general glaucoma outpatient department. There exists a discrepancy between patient management decisions of reviewers, suggesting that some may be more risk averse than others when managing patients seen within this model. Future work will assess the ability to detect progression of disease in this model compared with the general outpatient model of care.

Cost-effectiveness of the implantable HeartMate II left ventricular assist device for patients awaiting heart transplantation

Left ventricular assist devices (LVADs) are being proposed as a life-saving therapeutic alternative to conventional medical management for people with end-stage heart failure awaiting transplantation. However, cost-effectiveness assessments of first-generation LVADs have not been encouraging. The cost-effectiveness of the enhanced second-generation LVAD HeartMate II (Thoratec, Pleasanton, CA) is estimated here. A probabilistic Markov model was developed to extrapolate survival, utility, and resource use over the total lifetime of a hypothetic cohort of patients with end-stage heart failure under the 2 competing therapeutic strategies, using the most robust and recently published evidence about their performance. Cost data are based on UK activity to consider reimbursement in the UK National Health Service setting. HeartMate II had a mean cost per quality-adjusted life-year (QALY) of £258,922 ($414,275). The sensitivity analysis showed that 2 factors mainly explain why HeartMate II is not a cost-effectiveness strategy as a bridge-to-transplant: (1) the survival of heart transplant candidates treated conventionally while on the waiting list has significantly improved in recent years, and (2) the high acquisition cost of the device, £94,200 ($150,720). Although HeartMate II LVAD implantation significantly increases survival compared with conventional medical management, it does not provide good value for the money spent according to established thresholds of cost-effectiveness in the UK. HeartMate II is unlikely to become cost-effective unless the additional survival gained by its use raises and/or the device is given free of charge. Therefore, its implantation to transplant candidates lacks justification in terms of cost-effectiveness.

Family-based behavioural treatment of childhood obesity in a UK national health service setting: randomized controlled trial

BackgroundThe best outcomes for treating childhood obesity have come from comprehensive family-based programmes. However there are questions over their generalisability.ObjectiveTo examine the acceptability and effectiveness of ‘family-based behavioural treatment’ (FBBT) for childhood obesity in an ethnically and socially diverse sample of families in a UK National Health Service (NHS) setting.MethodsIn this parallel group, randomised controlled trial, 72 obese children were randomised to FBBT or waiting list control. Primary outcomes were body mass index (BMI) and BMI standard deviation scores (SDS). Secondary outcomes were weight, weight SDS, height, height SDS, waist, waist SDS, fat mass index, fat free mass index, blood pressure, and psychosocial measures. Outcomes were assessed at baseline and post-treatment, with analyses on the 6 month data done on an intent-to-treat (ITT) basis. Follow-up anthropometric data were collected at twelve months for the treatment group.ResultsITT analyses included all children with baseline data (n=60). There were significant BMI SDS changes (p<0.01) for the treatment and control groups of −0.11 (0.16) and −0.10 (1.6). The treatment group showed a significant reduction in systolic blood pressure (−0.24 (0.7), p<0.05) and improvements in quality of life and eating attitudes (p<0.05), with no significant changes for the control group. However the between-group treatment effects for BMI, body composition, blood pressure and psychosocial outcomes were not significant. There was no overall change in BMI or BMI SDS from 0-12 months for the treatment group. No adverse effects were reported.ConclusionsBoth treatment and control groups experienced significant reductions in level of overweight, but with no significant difference between them. There were no significant group differences for any of the secondary outcomes.

Comparative clinical- and cost-effectiveness of candesartan and losartan in the management of hypertension and heart failure: a systematic review, meta- and cost-utility analysis

The UK National Health Service (NHS) currently spends in excess of £250 million per annum on angiotensin II receptor blockers (ARBs) for the treatment of hypertension and heart failure; with candesartan currently dominating the market. With the recent introduction of generic losartan, we set out to directly compare the branded market leader to its now cheaper alternative. The primary objectives were to compare the blood pressure (BP) lowering efficacy and cardiovascular outcomes of candesartan and losartan in the treatment of essential hypertension and chronic heart failure, respectively. The secondary objective was to model their comparative incremental cost-effectiveness in a UK NHS setting. The Cochrane Central Register of Controlled Trials (Cochrane Library 2009, issue 2), which contains the Hypertension and Heart Group's specialist register, Medline (1950-February 2010), and Embase (1980-February 2010) were included in the search strategy. Selection criteria were randomised studies of candesartan versus losartan in adults (> 18 years). The main outcome measures were as follows: Hypertension: mean change from baseline in trough (24 h postdose) systolic and diastolic BP. Heart failure: composite of cardiovascular death and hospital admission for management of heart failure. Two reviewers applied inclusion criteria, assessed trial quality, and extracted data. Eight (three of which met inclusion criteria) and zero trials compared candesartan directly with losartan in the treatment of hypertension and heart failure, respectively. A between-treatment difference of -1.96 mmHg [95% confidence interval (CI) -2.40 to -1.51] for trough diastolic BP and -3.00 mmHg (95% CI -3.79 to -2.22) for trough systolic BP in favour of candesartan was observed. Based on this differential, a 10-year Markov model estimates the cost per quality-adjusted life-year gained to exceed £40,000 for using candesartan in place of generic losartan. Candesartan reduces BP to a slightly greater extent when compared with losartan, however, such difference is unlikely to be cost-effective based on current acquisition costs, perceived NHS affordability thresholds and use of combination regimens. We could find no robust evidence supporting the superiority of candesartan over losartan in the treatment of heart failure. We therefore recommend using generic losartan as the ARB of choice which could save the UK NHS approximately £200 million per annum in drug costs.