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Background: Community First Responders are trained volunteers dispatched by ambulance services to potentially life-threatening emergencies such as cardiac arrest in the first vital minutes to provide care until highly skilled ambulance staff arrive. Community First Responder schemes were first introduced to support ambulance services in rural communities, where access to prehospital emergency care is more likely to be delayed. Evidence is lacking on their contribution to rural healthcare provision, how care is provided and how this might be improved., Objectives: We aimed to describe Community First Responder activities, organisation, costs of provision and outcomes of care together with perceptions and views of patients, public, Community First Responders, ambulance service staff and commissioners of their current and future role including innovations in the rural health and care workforce., Design: We used a mixed-methods design, using a lens of pragmatism and the 'actor', 'behaviour change' and 'causal pathway' framework to integrate quantitative routine and qualitative (policy, guideline and protocol documents with stakeholder interview) data from 6 of 10 English ambulance services. We identified potential innovations in Community First Responder provision and prioritised these using a modified nominal group technique. Patients and public were involved throughout the study., Results: In 4.5 million incidents from six English regional ambulance services during 2019, pre COVID-19 pandemic, Community First Responders attended first a higher proportion of calls in rural areas (almost 4% of calls) than in urban areas (around 1.5%). They were significantly more likely to be called out to rural (vs. urban) areas and to attend older (vs. younger), white (vs. minority ethnic) people in more affluent (vs. deprived) areas with cardiorespiratory and neurological (vs. other emergency) conditions for higher-priority emergency or urgent (category 1 and 2 compared with category 3, 4 or 5) calls but did also attend lower-category calls for conditions such as falls. We examined 10 documents from seven ambulance services. Ambulance policies and protocols integrated Community First Responders into ambulance service structures to achieve the safe and effective operation of volunteers. Costs, mainly for training, equipment and support, varied widely but were not always clearly delineated. Community First Responders enabled a faster prehospital response time. There was no clear benefit in out-of-hospital cardiac arrest outcomes. A specific Community First Responder falls response reduced ambulance attendances and was potentially cost saving. We conducted semistructured interviews with 47 different stakeholders engaged in Community First Responder functions. This showed the trajectory of becoming a Community First Responder, the Community First Responder role, governance and practice, and the positive views of Community First Responders from stakeholders despite public lack of understanding of their role. Community First Responders' scope of practice varied between ambulance services and had developed into new areas. Innovations prioritised at the consensus workshop were changes in processes and structures and an expanded scope of practice supported by training, which included counselling, peer support, better communication with the control room, navigation and communication technology, and specific mandatory and standardised training for Community First Responders., Limitations: Missing data and small numbers of interviews in some stakeholder groups (patients, commissioners) are sources of bias., Future Research: Future research should include a robust evaluation of innovations involving Community First Responders., Trial Registration: This trial is registered as ClinicalTrials.gov, NCT04279262., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR127920) and is published in full in Health and Social Care Delivery Research ; Vol. 12, No. 18. See the NIHR Funding and Awards website for further award information.

"'Hypos' can strike twice" (HS2) is a pragmatic, leaflet-based referral intervention designed for administration by clinicians of the emergency medical services (EMS) to people they have attended and successfully treated for hypoglycaemia. Its main purpose is to encourage the recipient to engage with their general practitioner or diabetic nurse in order that improvements in medical management of their diabetes may be made, thereby reducing their risk of recurrent hypoglycaemia. Herein we build a de novo economic model for purposes of incremental analyses to compare, in 2018-19 prices, HS2 against standard care for recurrent hypoglycaemia in the fortnight following the initial attack from the perspective of the UK National Health Service (NHS). We found that per patient NHS costs incurred by people receiving the HS2 intervention over the fortnight following an initial hypoglycaemia average £49.79, and under standard care costs average £40.50. Target patient benefit assessed over that same period finds the probability of no recurrence of hypoglycaemia averaging 42.4% under HS2 and 39.4% under standard care, a 7.6% reduction in relative risk. We find that implementing HS2 will cost the NHS an additional £309.36 per episode of recurrent hypoglycaemia avoided. Contrary to the favourable support offered in Botan et al., we conclude that in its current form the HS2 intervention is not a cost-effective use of NHS resources when compared to standard NHS care in reducing the risk of hypoglycaemia recurring within a fortnight of an initial attack that was resolved at-scene by EMS ambulance clinicians., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Smith et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Aim: To model optimum proportions of dual-crewed ambulances (DCAs) and rapid-response vehicles (RRVs) in Ambulance Trusts with a view to generating a policy brief for one Ambulance Trust and a modelling tool for other Trusts on the strategic procurement and allocation of emergency vehicle (EV) resources., Methods: Historical EV assignments for 12 months of emergency calls in 2019 were provided by an NHS Ambulance Trust and analysed for backup, see and treat, and patient to hospital conveyance. Unit costs were derived for paramedics and technicians using Agenda for Change pay rates. Time cycles were assigned for RRV and DCA attendances and unit costs assigned to these. Information was put into a decision analytical model to estimate the costs and numbers of vehicles attending incidents based on relative proportions of available RRVs and DCAs., Results: Of 711 992 calls attended by 837 107 EVs, 514 766 (72.3%) required at least one emergency department conveyance. The rate of conveyance was significantly lower when RRVs arrived first on the scene. 27 883 out of 529 693 (5.3%) DCAs first arriving at an incident required some backup, and this was also factored into the model. Modelling demonstrated high conveyance rates were counterproductive when increasing the relative proportions of RRVs to DCAs. For example, with conveyance rates of 65%, increasing the RRVs increased the cost and numbers of vehicles attending per incident. At lower conveyance rates, however, there was a levelling around 30% where it could become cost-effective to increase the relative proportions of RRVs to DCAs., Conclusion: At current overall conveyance rates, there is no benefit in increasing the relative proportions of RRVs to DCAs unless additional benefits can be realised that bring the conveyance rates down., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: We aimed to investigate the effect of an intervention in which ambulance personnel provided advice supported by a booklet-'Hypos can strike twice'-issued following a hypoglycaemic event to prevent future ambulance attendances., Methods: We used a non-randomised stepped wedge-controlled design. The intervention was introduced at different times (steps) in different areas (clusters) of operation within East Midlands Ambulance Service NHS Trust (EMAS). During the first step (T0), no clusters were exposed to the intervention, and during the last step (T3), all clusters were exposed. Data were analysed using a general linear mixed model (GLMM) and an interrupted-time series analysis (ITSA)., Results: The study included 4825 patients (mean age 65.42 years, SD 19.42; 2,166 females) experiencing hypoglycaemic events attended by EMAS. GLMM indicated a reduction in the number of unsuccessful attendances (i.e., attendance followed by a repeat attendance) in the final step of the intervention when compared to the first (odds ratio OR: 0.50, 95%CI: 0.33-0.76, p = 0.001). ITSA indicated a significant decrease in repeat ambulance attendances for hypoglycaemia-relative to the pre-intervention trend (p = 0.008). Furthermore, the hypoglycaemia care bundle was delivered in 66% of attendances during the intervention period, demonstrating a significant level of practice change (p < 0.001)., Conclusion: The 'Hypos can strike twice' intervention had a positive effect on reducing numbers of repeat attendances for hypoglycaemia and in achieving the care bundle. The study supports the use of information booklets by ambulance clinicians to prevent future attendances for recurrent hypoglycaemic events., (© 2021 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

Objectives: Health economics analysis plans (HEAPs) currently lack consistency, with uncertainty surrounding appropriate content. We aimed to develop a list of essential items that should be included in HEAPs for economic evaluations conducted alongside randomized trials., Methods: A list of potential items for inclusion was developed by examining existing HEAPs. An electronic Delphi survey was conducted among professional health economists. Respondents were asked to rate potential items from 1 (least important) to 9 (most important), suggest additional items, and comment on proposed items (round 1). A second survey (round 2) was emailed to participants, including the participant's own scores from round 1 along with summary results from the whole panel; participants were asked to rerate each item. Consensus criteria for inclusion in the final list were predefined as >70% of participants rating an item 7-9 and <15% rating it 1-3 after round 2. A final item selection meeting was held to scrutinize the results and adjudicate on items lacking consensus., Results: 62 participants completed round 1 of the survey. The initial list included 72 potential items; all 72 were carried forward to round 2, and no new items were added. 48 round 1 respondents (77.4%) completed round 2 and reached consensus on 53 items. At the final meeting, the expert panel (n = 9) agreed that 58 items should be included in the essential list, moved 9 items to an optional list, and dropped 5 items., Conclusions: Via expert consensus opinion, this study identified 58 items that are considered essential in a HEAP., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: The risk of developing long-term complications of type 1 diabetes (T1D) is related to glycaemic control and is reduced by the use of intensive insulin treatment regimens: multiple daily injections (MDI) (≥ 4) and continuous subcutaneous insulin infusion (CSII). Despite a lack of evidence that the more expensive treatment with CSII is superior to MDI, both treatments are used widely within the NHS., Objectives: (1) To compare glycaemic control during treatment with CSII and MDI and (2) to determine safety and cost-effectiveness of the treatment, and quality of life (QoL) of the patients., Design: A pragmatic, open-label randomised controlled trial with an internal pilot and 12-month follow-up with 1 : 1 web-based block randomisation stratified by age and centre., Setting: Fifteen diabetes clinics in hospitals in England and Wales., Participants: Patients aged 7 months to 15 years., Interventions: Continuous subsutaneous insulin infusion or MDI initiated within 14 days of diagnosis of T1D., Data Sources: Data were collected at baseline and at 3, 6, 9 and 12 months using paper forms and were entered centrally. Data from glucometers and CSII were downloaded. The Health Utilities Index Mark 2 was completed at each visit and the Pediatric Quality of Life Inventory (PedsQL, diabetes module) was completed at 6 and 12 months. Costs were estimated from hospital patient administration system data., Outcomes: The primary outcome was glycosylated haemoglobin (HbA 1c ) concentration at 12 months. The secondary outcomes were (1) HbA 1c concentrations of < 48 mmol/mol, (2) severe hypoglycaemia, (3) diabetic ketoacidosis (DKA), (4) T1D- or treatment-related adverse events (AEs), (5) change in body mass index and height standard deviation score, (6) insulin requirements, (7) QoL and (8) partial remission rate. The economic outcome was the incremental cost per quality-adjusted life-year (QALY) gained., Results: A total of 293 participants, with a median age of 9.8 years (minimum 0.7 years, maximum 16 years), were randomised (CSII, n  = 149; MDI, n  = 144) between May 2011 and January 2015. Primary outcome data were available for 97% of participants (CSII, n  = 143; MDI, n  = 142). At 12 months, age-adjusted least mean squares HbA 1c concentrations were comparable between groups: CSII, 60.9 mmol/mol [95% confidence interval (CI) 58.5 to 63.3 mmol/mol]; MDI, 58.5 mmol/mol (95% CI 56.1 to 60.9 mmol/mol); and the difference of CSII - MDI, 2.4 mmol/mol (95% CI -0.4 to 5.3 mmol/mol). For HbA 1c concentrations of < 48 mmol/mol (CSII, 22/143 participants; MDI, 29/142 participants), the relative risk was 0.75 (95% CI 0.46 to 1.25), and for partial remission rates (CSII, 21/86 participants; MDI, 21/64), the relative risk was 0.74 (95% CI 0.45 to 1.24). The incidences of severe hypoglycaemia (CSII, 6/144; MDI, 2/149 participants) and DKA (CSII, 2/144 participants; MDI, 0/149 participants) were low. In total, 68 AEs (14 serious) were reported during CSII treatment and 25 AEs (eight serious) were reported during MDI treatment. Growth outcomes did not differ. The reported insulin use was higher with CSII (mean difference 0.1 unit/kg/day, 95% CI 0.0 to 0.2 unit/kg/day; p  = 0.01). QoL was slightly higher for those randomised to CSII. From a NHS perspective, CSII was more expensive than MDI mean total cost (£1863, 95% CI £1620 to £2137) with no additional QALY gains (-0.006 QALYs, 95% CI -0.031 to 0.018 QALYs)., Limitations: Generalisability beyond 12 months is uncertain., Conclusions: No clinical benefit of CSII over MDI was identified. CSII is not a cost-effective treatment in patients representative of the study population., Future Work: Longer-term follow-up is required to determine if clinical outcomes diverge after 1 year. A qualitative exploration of patient and professional experiences of MDI and CSII should be considered., Trial Registration: Current Controlled Trials ISRCTN29255275 and EudraCT 2010-023792-25., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 42. See the NIHR Journals Library website for further project information. The cost of insulin pumps and consumables supplied by F. Hoffman-La Roche AG (Basel, Switzerland) for the purpose of the study were subject to a 25% discount on standard NHS costs., Competing Interests: Joanne Blair undertakes paid advisory work for, and has received funding for research, to attend academic meetings and to support a nursing salary from, Novo Nordisk Ltd (Gatwick, UK), a pharmaceutical company that manufactures some of the insulins used in the SubCutaneous Insulin: Pumps or Injections? (SCIPI) study. The work undertaken by Joanne Blair for Novo Nordisk Ltd relates to growth hormone therapy and not diabetes. Mohammed Didi has received payment for advisory work and funding to attend academic meetings and to support a nursing salary from Novo Nordisk Ltd. The work undertaken by Mohammed Didi for Novo Nordisk Ltd relates to growth hormone therapy and not diabetes. Mohammed Didi has received expenses from Merck Serono Ltd (Feltham, UK) to attend educational meetings. Carrol Gamble is a member of the Efficacy and Mechanism Evaluation Programme Board of the National Institute for Health Research. Dyfrig Hughes is a member of the Health Technology Assessment (HTA) Clinical Trials Board (2010–16), the HTA Funding Teleconference (2015–16) and the Pharmaceuticals Panel (2008–12). John W Gregory reports grants from Cardiff University during the conduct of the study, and membership of the HTA Commissioning Board (2010–14). John W Gregory received speaker fees from Pfizer Inc. and Eli Lilly and Company (Basingstoke, UK), fees for attending an advisory board for Eli Lilly and Company and financial assistance to attend annual meetings of the European Society for Paediatric Endocrinology from Sanofi Genzyme (Guildford, UK), Merck Serono Ltd, Ipsen and Novo Nordisk Ltd.

Background: Resource use measurement by patient recall is characterized by inconsistent methods and a lack of validation. A validated standardized resource use measure could increase data quality, improve comparability between studies, and reduce research burden., Objectives: To identify a minimum set of core resource use items that should be included in a standardized adult instrument for UK health economic evaluation from a provider perspective., Methods: Health economists with experience of UK-based economic evaluations were recruited to participate in an electronic Delphi survey. Respondents were asked to rate 60 resource use items (e.g., medication names) on a scale of 1 to 9 according to the importance of the item in a generic context. Items considered less important according to predefined consensus criteria were dropped and a second survey was developed. In the second round, respondents received the median score and their own score from round 1 for each item alongside summarized comments and were asked to rerate items. A final project team meeting was held to determine the recommended core set., Results: Forty-five participants completed round 1. Twenty-six items were considered less important and were dropped, 34 items were retained for the second round, and no new items were added. Forty-two respondents (93.3%) completed round 2, and greater consensus was observed. After the final meeting, 10 core items were selected, with further items identified as suitable for "bolt-on" questionnaire modules., Conclusions: The consensus on 10 items considered important in a generic context suggests that a standardized instrument for core resource use items is feasible., (Copyright © 2018. Published by Elsevier Inc.)

Trial-based economic evaluations are an important aspect of health technology assessment. The availability of patient-level data coupled with unbiased estimates of clinical outcomes means that randomised controlled trials are effective vehicles for the generation of economic data. However there are methodological challenges to trial-based evaluations, including the collection of reliable data on resource use and cost, choice of health outcome measure, calculating minimally important differences, dealing with missing data, extrapolating outcomes and costs over time and the analysis of multinational trials. This review focuses on the state of the art of selective elements regarding the design, conduct, analysis and reporting of trial-based economic evaluations. The limitations of existing approaches are detailed and novel methods introduced. The review is internationally relevant but with a focus towards practice in the UK.

Accurate resource-use measurement is challenging within an economic evaluation, but is a fundamental requirement for estimating efficiency. Considerable research effort has been concentrated on the appropriate measurement of outcomes and the policy implications of economic evaluation, while methods for resource-use measurement have been relatively neglected. Recently, the Database of Instruments for Resource Use Measurement (DIRUM) was set up at http://www.dirum.org to provide a repository where researchers can share resource-use measures and methods. A workshop to discuss the issues was held at the University of Birmingham in October 2011. Based on material presented at the workshop, this article highlights the state of the art of UK instruments for resource-use data collection based on patient recall. We consider methodological issues in the design and analysis of resource-use instruments, and the challenges associated with designing new questionnaires. We suggest a method of developing a good practice guideline, and identify some areas for future research. Consensus amongst health economists has yet to be reached on many aspects of resource-use measurement. We argue that researchers should now afford costing methodologies the same attention as outcome measurement, and we hope that this Current Opinion article will stimulate a debate on methods of resource-use data collection and establish a research agenda to improve the precision and accuracy of resource-use estimates.