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OBJECTIVES: Standard medical management of spontaneous intracerebral haemorrhage (ICH) and surgical hematoma evacuation starkly differ, and whilst landmark randomised control trials report no clinical benefit of early surgical evacuation compared with medical treatment in supratentorial ICH, minimally invasive surgery (MIS) with thrombolysis has been neglected within these studies. However, recent technological advancements in MIS have renewed interest in the surgical treatment of ICH. Several economic evaluations have focused on the benefits of MIS in ischaemic stroke management, but no economic evaluations have yet been performed comparing MIS to standard medical treatment for ICH.MATERIALS AND METHOD: All costs were sourced from the UK in GBP. Where possible, the 2019/2020 NHS reference costs were used. The MISTIE III study was used to analyse the outcomes of patients undergoing either MIS or standard medical treatment in this economic evaluation.RESULTS: The incremental cost-effectiveness ratio (ICER) for MIS was £485,240.26 for every quality-adjusted life year (QALY) gained. Although MIS resulted in a higher QALY compared to medical treatment, the gain was insignificant at 0.011 QALY. Four sensitivity analyses based on combinations of alternative EQ-5D values and categorisation of MIS outcomes, alongside alterations to the cost of significant adverse events, were performed to check the robustness of the ICER calculation. The most realistic sensitivity analysis showed a potential increase in cost effectiveness when clot size is reduced to DISCUSSION: From the perspective of the NHS, MIS with thrombolysis is not cost-effective compared to optimal medical treatment. ICER shows that intention-to-treat MIS would require a cost of £485,240.26 to gain one extra QALY, which is significantly above the NHS threshold of £30,000. Further UK studies with ICH survivor utilities, more replicable surgical technique, and the reporting of clot size reduction are indicated as the present sensitivity analysis suggests that MIS is promising. Greater detail about outcomes and complications would ensure improved cost-benefit analyses and support valid and efficient allocation of resources by the NHS.

Background The majority of people do not achieve recommended levels of physical activity. There is a need for effective, scalable interventions to promote activity. Self-monitoring by pedometer is a potentially suitable strategy. We assessed the effectiveness and cost-effectiveness of a very brief (5-minute) pedometer-based intervention (‘Step It Up’) delivered as part of National Health Service (NHS) Health Checks in primary care. Methods and findings The Very Brief Intervention (VBI) Trial was a two parallel-group, randomised controlled trial (RCT) with 3-month follow-up, conducted in 23 primary care practices in the East of England. Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check. They were randomly allocated (1:1) using a web-based tool between October 1, 2014, and December 31, 2015, to either intervention (505) or control group (502), stratified by primary care practice. Participants were aware of study group allocation. Control participants received the NHS Health Check only. Intervention participants additionally received Step It Up: a 5-minute face-to-face discussion, written materials, pedometer, and step chart. The primary outcome was accelerometer-based physical activity volume at 3-month follow-up adjusted for sex, 5-year age group, and general practice. Secondary outcomes included time spent in different intensities of physical activity, self-reported physical activity, and economic measures. We conducted an in-depth fidelity assessment on a subsample of Health Check consultations. Participants’ mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment. The primary outcome was available in 859 (85.3%) participants. There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI −18.7 to 36.3; p = 0.53). We found no significant between-group differences in the secondary outcomes of step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables). Of the 505 intervention participants, 491 (97%) received the Step it Up intervention. Analysis of 37 intervention consultations showed that 60% of Step it Up components were delivered faithfully. The intervention cost £18.04 per participant. Incremental cost to the NHS per 1,000-step increase per day was £96 and to society was £239. Adverse events were reported by 5 intervention participants (of which 2 were serious) and 5 control participants (of which 2 were serious). The study’s limitations include a participation rate of 16% and low return of audiotapes by practices for fidelity assessment. Conclusions In this large well-conducted trial, we found no evidence of effect of a plausible very brief pedometer intervention embedded in NHS Health Checks on objectively measured activity at 3-month follow-up. Trial registration Current Controlled Trials (ISRCTN72691150)., Wendy Hardeman and colleagues investigate a short physical activity intervention in a randomized controlled trial., Author summary Why was this study done? Systematic reviews support the effectiveness and cost-effectiveness of brief (up to 30 minutes) physical activity interventions in primary care and the effectiveness of intensive pedometer interventions. There is a need for briefer interventions in primary care, where time is limited but potential reach is large. However, the reviews show uncertainty about the effectiveness and cost-effectiveness of very brief (up to 5 minutes) interventions in primary care. Until now, there have been no randomised controlled trials (RCTs) of a very brief pedometer-based intervention to increase physical activity in primary care. What did the researchers do and find? We randomly assigned participants who attended preventive health checks in primary care (National Health Service [NHS] Health Checks) to the health check alone or additionally a very brief pedometer-based physical activity intervention delivered by practice nurses or healthcare assistants. We measured physical activity objectively at 3 months after the intervention. Our large trial found no benefit of a very brief physical activity intervention in the context of preventive health checks in primary care. Despite the intervention being apparently simple and very brief, fidelity of delivery was suboptimal. Trial participants were more active than might have been expected. The economic evaluation shows a small added cost for a small and uncertain benefit. What do these findings mean? The absence of a positive effect of a very brief physical activity intervention challenges the commissioning of such interventions in this context. Primary care practitioners should continue to opportunistically provide very brief advice about physical activity.

Background Eighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Methods The Cessation in Pregnancy Incentives Trial (CPIT) III is a pragmatic, 42-month, multi-centre, parallel-group, individually randomised controlled superiority trial of the effect on smoking status of adding to usual Stop Smoking Services (SSS) support, the offer of up to £400 of financial voucher incentives, compared with usual support alone, to quit smoking during pregnancy. Participants (n = 940) are pregnant smokers (age > 16 years, The primary outcome is cotinine/anabasine-validated abstinence from smoking in late pregnancy. Secondary outcomes include engagement with SSS, quit rates at 4 weeks from agreed quit date and 6 months after birth, and birth weight. Outcomes will be analysed by intention to treat, and regression models will be used to compare treatment effects on outcomes. A meta-analysis will include data from the feasibility study in Glasgow. An economic evaluation will assess cost-effectiveness from a UK NHS perspective. Process evaluation using a case-study approach will identify opportunities to improve recruitment and learning for future implementation. Research questions include: what is the therapeutic efficacy of incentives; are incentives cost-effective; and what are the potential facilitators and barriers to implementing incentives in different parts of the UK? Discussion This phase III trial in Scotland, England and Northern Ireland follows a successful phase II trial in Glasgow, UK. The participating sites have diverse SSS that represent most cessation services in the UK and serve demographically varied populations. If found to be acceptable and cost-effective, this trial could demonstrate that financial incentives are effective and transferable to most UK SSS for pregnant women. Trial registration Current Controlled Trials, ISRCTN15236311. Registered on 9 October 2017.

Background This study aimed to assess whether there are potential areas for efficiency improvements in the National Health Service (NHS) orthodontic service in North West England and to assess the socioeconomic status (SES)-related equity of the outcomes achieved by the NHS. Methods The study involved a retrospective analysis of 2008–2012 administrative data, and the study population comprised patients aged ≥10 who started NHS primary care orthodontic treatment in North West England in 2008. The proportions of treatments that were discontinued early and ended with residual need (based on post-treatment Index of Orthodontic Treatment Need [IOTN] scores that met or exceeded the NHS eligibility threshold of 3.6) and the associated NHS expenditure were calculated. In addition, the associations with SES were investigated using linear probability models. Results We found that 7.6% of treatments resulted in discontinuation (which was associated with an NHS annual expenditure of £2.3 m), and a further 19.4% (£5.9 m) had a missing outcome record. Furthermore, 5.2% of treatments resulted in residual need (£1.6 m), and a further 38.3% (£11.6 m) had missing IOTN data (due to either a missing outcome record or an incomplete IOTN outcome field in the record), which led to an annual NHS expenditure of £13.2 m (44% of the total expenditure) on treatments that are a potential source of inefficiency. Compared to the patients in the highest SES group, those in the lower SES groups were more likely both to discontinue treatment and to have residual need on treatment completion. Conclusions Substantial inefficiencies were evident in the NHS orthodontic service, with 7.6% of treatments ending in discontinuation (£2.3 m) and 5.2% ending with residual need (£1.6 m). Over a third of cases had unreported IOTN outcome scores, which highlights the need to improve the outcome monitoring systems. In addition, the SES gradients indicate inequity in the orthodontic outcomes, with children from disadvantaged communities having poorer outcomes compared to their more affluent peers. Electronic supplementary material The online version of this article (10.1186/s12903-017-0414-1) contains supplementary material, which is available to authorized users.

BackgroundBehavioural counselling with intensive follow-up for obesity is effective, but in resource-constrained primary care settings briefer approaches are needed.ObjectivesTo estimate the clinical effectiveness and cost-effectiveness of an internet-based behavioural intervention with regular face-to-face or remote support in primary care, compared with brief advice.DesignIndividually randomised three-arm parallel trial with health economic evaluation and nested qualitative interviews.SettingPrimary care general practices in the UK.ParticipantsPatients with a body mass index of ≥ 30 kg/m2(or ≥ 28 kg/m2with risk factors) identified from general practice records, recruited by postal invitation.InterventionsPositive Online Weight Reduction (POWeR+) is a 24-session, web-based weight management intervention completed over 6 months. Following online registration, the website randomly allocated participants using computer-generated random numbers to (1) the control intervention (n = 279), which had previously been demonstrated to be clinically effective (brief web-based information that minimised pressure to cut down foods, instead encouraging swaps to healthier choices and increasing fruit and vegetables, plus 6-monthly nurse weighing); (2) POWeR+F (n = 269), POWeR+ supplemented by face-to-face nurse support (up to seven contacts); or (3) POWeR+R (n = 270), POWeR+ supplemented by remote nurse support (up to five e-mails or brief telephone calls).Main outcome measuresThe primary outcome was a modelled estimate of average weight reduction over 12 months, assessed blind to group where possible, using multiple imputation for missing data. The secondary outcome was the number of participants maintaining a 5% weight reduction at 12 months.ResultsA total of 818 eligible individuals were randomised using computer-generated random numbers. Weight change, averaged over 12 months, was documented in 666 out of 818 participants (81%; control,n = 227; POWeR+F,n = 221; POWeR+R,n = 218). The control group maintained nearly 3 kg of weight loss per person (mean weight per person: baseline, 104.4 kg; 6 months, 101.9 kg; 12 months, 101.7 kg). Compared with the control group, the estimated additional weight reduction with POWeR+F was 1.5 kg [95% confidence interval (CI) 0.6 to 2.4 kg;p = 0.001] and with POWeR+R was 1.3 kg (95% CI 0.34 to 2.2 kg;p = 0.007). By 12 months the mean weight loss was not statistically significantly different between groups, but 20.8% of control participants, 29.2% of POWeR+F participants (risk ratio 1.56, 95% CI 0.96 to 2.51;p = 0.070) and 32.4% of POWeR+R participants (risk ratio 1.82, 95% CI 1.31 to 2.74;p = 0.004) maintained a clinically significant 5% weight reduction. The POWeR+R group had fewer individuals who reported doing another activity to help lose weight [control, 47.1% (64/136); POWeR+F, 37.2% (51/137); POWeR+R, 26.7% (40/150)]. The incremental cost to the health service per kilogram weight lost, compared with the control group, was £18 (95% CI –£129 to £195) for POWeR+F and –£25 (95% CI –£268 to £157) for POWeR+R. The probability of being cost-effective at a threshold of £100 per kilogram was 88% and 98% for POWeR+F and POWeR+R, respectively. POWeR+R was dominant compared with the control group. No harms were reported and participants using POWeR+ felt more enabled in managing their weight. The qualitative studies documented that POWeR+ was viewed positively by patients and that health-care professionals generally enjoyed supporting patients using POWeR+.Study limitationsMaintenance of weight loss after 1 year is unknown.Future workIdentifying strategies for longer-term engagement, impact in community settings and increasing physical activity.ConclusionClinically valuable weight loss (> 5%) is maintained in 20% of individuals using novel written materials with brief follow-up. A web-based behavioural programme and brief support results in greater mean weight loss and 10% more participants maintain valuable weight loss; it achieves greater enablement and fewer participants undertaking other weight-loss activities; and it is likely to be cost-effective.Trial registrationCurrent Controlled Trials ISRCTN21244703.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 4. See the NIHR Journals Library website for further project information.

Objectives It is increasingly recognized that the design characteristics of pay-for-performance schemes are important in determining their impact. One important but under-studied design aspect is the extent to which pay-for-performance schemes reflect local priorities. The English Department of Health White Paper High Quality Care for All introduced a Commissioning for Quality and Innovation (CQUIN) Framework from April 2009, under which local commissioners and providers were required to negotiate and implement an annual pay-for-performance scheme. In 2010/2011, these schemes covered 1.5% (£1.0bn) of NHS expenditure. Local design was intended to offer flexibility to local priorities and generate local enthusiasm, while retaining good design properties of focusing on outcomes and processes with a clear link to quality, using established indicators where possible, and covering three key domains of quality (safety; effectiveness; patient experience) and innovation. We assess the extent to which local design achieved these objectives. Methods Quantitative analysis of 337 locally negotiated CQUIN schemes in 2010/2011, along with qualitative analysis of 373 meetings (comprising 800 hours of observation) and 230 formal interviews (audio-recorded and transcribed verbatim) with NHS staff in 12 case study sites. Results The local development process was successful in identifying variation in local needs and priorities for quality improvement but the involvement of frontline clinical staff was insufficient to generate local enthusiasm around the schemes. The schemes did not in general live up to the requirements set by the Department of Health to ensure that local schemes addressed the original objectives for the CQUIN framework. Conclusions While there is clearly an important case for local strategic and clinical input into the design of pay-for-performance schemes, this should be kept separate from the technical design process, which involves defining indicators, agreeing thresholds, and setting prices. These tasks require expertise that is unlikely to exist in each locality. The CQUIN framework potentially offered an opportunity to learn how technical design influenced outcome but due to the high degree of local experimentation and little systematic collection of key variables, it is difficult to derive lessons from this unstructured experiment about the impact and importance of different technical design factors on the effectiveness of pay-for-performance. Balancing the policy goal of localism with the objective of improving patient outcomes leads us to conclude that a somewhat firmer national framework would be preferable to a fully locally designed framework.