Rachel Ann Elliott

Aims: NHS England adopted ‘HeLP‐Diabetes’, a web‐based diabetes self‐management and education service, effective in a clinical trial and implemented it across England as ‘Healthy Living for people with type 2 diabetes’ (Healthy Living). This paper aims to narratively synthesise findings from a programme of mixed‐methods evaluations undertaken alongside the national implementation. Methods: Interviews with programme users and NHS staff, content analysis of the website, analysis of anonymised large datasets and calculation of the costs and health benefits. Results: Service users and health professionals welcomed Healthy Living and made suggestions for improvement. The web content had fidelity to HeLP‐Diabetes and was suitable for supporting self‐management. Similar to other online programmes, there was variation in uptake and retention, and many people spent a short time engaging. Despite these challenges, Healthy Living registrants had modestly lower blood glucose at one year (by −1 mmol/mol (95% CI: −2, −1); −0.1% (95% CI: −0.2%; −0.1%)) compared with usual care; results were better in those using the programme more, and it was cost‐effective. Conclusions: We present the first logic model of a UK diabetes self‐management and education programme. The implications for UK diabetes care include a need for clarity on eligibility for different services, the importance of expanding access to people from minority ethnicities and areas of highest deprivation, and the need to improve retention. A future research agenda includes achieving consensus on a roadmap through diabetes services, how and why people choose (or not) to participate in self‐management services, and which components of these services are most strongly associated with positive health benefits.

Aims: The National Health Service (NHS) offers Healthy Living , an online Diabetes Self‐Management Education and Support service, to help people Self Manage Type 2 Diabetes, with modest 1‐year reductions in HbA1c levels, systolic blood pressure and body mass index. We aim to assess the cost‐effectiveness of Healthy Living compared with usual care. Methods: A patient‐level economic simulation model (UKPDS‐OM2.1) was used to conduct an economic analysis from the NHS perspective over a lifetime horizon, discounted at 3.5%. The model translated risk factor reductions to long‐term cost and quality‐adjusted life year (QALY) estimates. Additional analyses estimated intervention and medication cost consequences. Results: The UKPDS‐OM2.1 predicted a modest improvement in health (0.016 QALYs) and a small reduction in lifetime healthcare costs (−£4 per person). Offsetting with intervention costs (£7 per user) and increased medication costs (£212 per user) yielded a net cost of £216 per user. The cost‐per‐QALY of £13,192 was below the lower NICE threshold (£25,000/QALY), indicating that the programme is cost‐effective. Sensitivity analyses largely demonstrated robustness, but the finding was sensitive to structural assumptions about disease progression post‐intervention with the inclusion of medication costs. Conclusion: Healthy Living appears to be a low‐cost, online intervention for self managing type 2 diabetes, generating modest health benefits that are likely to be considered cost‐effective use of NHS resources. While there is some uncertainty in the cost‐effectiveness and the modelling is based on effectiveness estimated from observational data, improvements in uptake and adherence has the potential to improve the value for money to the NHS.

Background: Hazardous prescribing is an important and expensive preventable cause of patient harm, which can be identified using electronic healthcare records. In our Programme Grant we investigated the large-scale roll-out of a type of clinical decision support called OptimiseRx ^® (First Databank, Hearst Health, Exeter, United Kingdom) (which had not been independently evaluated previously) and two large-scale roll-outs of pharmacist-led IT-based intervention (an intervention that had been shown to reduce hazardous prescribing in a cluster randomised trial). Objectives: To estimate harm and economic impact of specific hazardous prescribing events. To investigate whether a clinical decision support intervention (OptimiseRx) was associated with reduction in hazardous prescribing. To investigate whether a pharmacist-led IT-based intervention was associated with reduction in hazardous prescribing. To undertake economic and process evaluations of both interventions. Design and methods: The harm and economic impact of hazardous prescribing events were investigated using data from published sources to generate estimates of patient outcomes and cost associated with 11 prescribing safety indicators. An incomplete (not randomised) stepped-wedge design study with control groups was used to investigate the effectiveness of OptimiseRx (409 general practices). Incremental cost-effectiveness ratios were generated for OptimiseRx compared with standard care (cost per hazardous prescribing event prevented), subgroup analysis: cost per quality-adjusted life-year. Incomplete stepped-wedge design studies [East Midlands study (343 and 115 general practices); whole of England study (725 and 179 general practices)] investigated the effectiveness of pharmacist-led IT-based intervention. Incremental cost-effectiveness ratios were generated for pharmacist-led IT-based intervention compared with standard care (cost per hazardous prescribing event prevented, cost per quality-adjusted life-year). Data from interviews, focus groups, a survey and stakeholder events were analysed qualitatively to identify factors influencing the sustained implementation and operation of OptimiseRx or pharmacist-led IT-based intervention. Setting and participants: The interventions took place in general practices in England. The process evaluation involved clinicians, patients and other stakeholders in England. Interventions: Clinical decision support intervention (OptimiseRx). Pharmacist-led IT-based intervention. Main outcome measures: Changes in hazardous prescribing rates. Cost per quality-adjusted life-year. Data sources: Clinical Practice Research Datalink. ResearchOne. General practice clinical records. Process evaluation with clinicians, patients and other stakeholders. Results: All the hazardous prescribing events studied were associated with loss of quality-adjusted life-years. The costliest for the National Health Service were prescriptions of antipsychotics to patients with dementia (£1168 per patient) and anticoagulants in combination with nonsteroidal anti-inflammatory drugs (£1020 per patient). Of 409 practices included in the clinical decision support study, 227 (56%) were intervention practices. Deployment of OptimiseRx was associated with a 10% reduction in exposure to hazardous prescribing after 2 years (odds ratio 0.90, 95% confidence interval 0.88 to 0.92). OptimiseRx costs £14–48 per hazardous prescribing event prevented, depending on time point and patient volume. Based on two indicators only, OptimiseRx costs £236 per quality-adjusted life-year gained at 6 months and becomes dominant (quality-adjusted life-year increasing; cost saving) at 24 months. Of 343 general practices included in the East Midlands pharmacist-led IT-based intervention evaluation, we completed further data extraction for 115 (33.5%) of these. Pharmacist-led IT-based intervention was associated with a decrease in hazardous prescribing of 18% (adjusted odds ratio 0.82, 95% confidence interval 0.78 to 0.86) at 6 months, and 22% (adjusted odds ratio 0.78, 95% confidence interval 0.73 to 0.84) at 24 months post intervention. Pharmacist-led IT-based intervention generates approximately 0.15 quality-adjusted life-years per practice extra compared with no intervention. Expected savings do not fully offset delivery costs, so pharmacist-led IT-based intervention costs just over £1000 per practice. Pharmacist-led IT-based intervention was estimated to be £7449. With 12- and 24-month intervention effects, health gains rise to over 0.2 quality-adjusted life-years and net expenditure falls to < £800 per practice; around £3500 per quality-adjusted life-year gained. Of 725 practices that implemented pharmacist-led IT-based intervention nationally, we had usable data for only 179 because of the COVID-19 pandemic. For these practices, pharmacist-led IT-based intervention was associated with a reduction in hazardous prescribing of 11% (adjusted odds ratio 0.89, 95% confidence interval 0.86 to 0.92) at 6 months post intervention. The process evaluation studies demonstrated the importance of collaboration and system-level support for the clinical decision support and pharmacist-led IT-based interventions. Limitations: The main limitation was that we could not robustly evaluate the impact of OptimiseRx on serious harm outcomes and the analysis was limited for pharmacist-led IT-based intervention because of the COVID-19 pandemic. Future work: Further research is needed to determine whether interventions that reduce hazardous prescribing, also reduce serious harm to patients. Conclusions: Large-scale implementation of OptimiseRx was associated with reduced hazardous prescribing, at less than £50 per hazardous prescribing event avoided. Large-scale implementation of pharmacist-led IT-based intervention was also associated with reduced hazardous prescribing with a cost per quality-adjusted life-year of £7449. It should be noted, however, that these were quasi-experimental studies using observational data and so the findings may have been affected by unknown confounding. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1214-20012) and is published in full in Programme Grants for Applied Research ; Vol. 14, No. 15. See the NIHR Funding and Awards website for further award information.

Introduction: Glucocorticoid (GC) bridging therapy is recommended in patients with rheumatoid arthritis commencing a disease-modifying anti-rheumatic drug (DMARD). It is not clear whether GC therapy is better administered intramuscularly or orally and at what dose level. The aim of the LEADER trial is to identify the most effective and safest way of using steroids in patients with uncontrolled RA who are starting a DMARD. Methods and analysis: A multicentre, randomised, open-label, four-arm, parallel-group clinical trial with an internal pilot phase, economic evaluation and qualitative study of acceptability. Participants will be randomised to one of four arms: arm A, 30 mg oral prednisolone tapering over 6 weeks; arm B, 15 mg oral prednisolone tapering over 4 weeks; arm C, Intramuscularly 120 mg methylprednisolone; and arm D, Intramuscularly 80 mg methylprednisolone. Participants will be assessed at baseline (pre-GC intervention), 4, 12 and 24 weeks. The primary outcome measure is the mean DAS(CRP)−28 over 12 weeks. The primary comparison will be according to route of administration (oral vs intramuscular GC treatment) with secondary comparisons within route of administration to provide evidence of dose effectiveness. Toxicity will be measured using the Glucocorticoid Toxicity Index, a clinical outcome assessment and early morning cortisol level. LEADER will be conducted in ~30 sites delivering NHS care, recruiting a sample size of 448. Economic evaluation will compare cost-effectiveness within a trial and over a lifetime horizon from the English National Health Service perspective. Ethics and dissemination: The LEADER trial received MHRA and Leicester Central Research Ethics Committee ethics approval (REC reference: 24/EM/0277, IRAS 1010280), opened to recruitment on Protocol Version 4.0 and is currently recruiting on Protocol Version 5.0. Participants will provide written informed consent in accordance with the Declaration of Helsinki and applicable regulatory requirements. Trial results will be disseminated via presentations at national and international meetings, published in open-access journals and to patients. Trial registration number: ISRCTN32090559 .

Background: Suicide is a leading cause of death worldwide, particularly in people with severe mental health problems, including schizophrenia. The development, and testing, of suicide-focused psychological interventions which can combat suicidal experiences is an unrealised necessity. However, it is vital that suicide-focused therapies are derived from robust, evidence-based mechanistic suicide theories. The Schematic Appraisals Model of Suicide is one such theory. Objective(s): The Cognitive AppRoaches to coMbatting Suicidality project had two objectives. First, based on the Schematic Appraisals Model of Suicide, to test psychological pathways underlying suicidal thoughts, plans and attempts. Second, to test the efficacy of Cognitive–Behavioural Suicide Prevention for psychosis, a suicide-focused intervention developed by our team. Design: The randomised controlled trial had two groups: our suicide-focused therapy, Cognitive–Behavioural Suicide Prevention adapted Cognitive–Behavioural Suicide Prevention for psychosis, plus treatment as usual (treatment) versus treatment as usual only (control). There were three assessment time points of baseline, 6 and 12 months, with the 6-month time point being the critical point for the main primary outcome. Four qualitative methods workstreams were nested within the randomised controlled trial design. Settings: Four National Health Service Trust sites in the North West of England, United Kingdom: Greater Manchester Mental Health NHS Foundation Trust, Pennine Care NHS Foundation Trust, Lancashire and South Cumbria NHS Foundation Trust, and the former North West Boroughs Healthcare NHS Foundation Trust. Participants: Main inclusion criteria: (1) non-affective psychosis (e.g. schizophrenia), (2) suicidal experiences in the 3 months prior to recruitment; (3) under the care of an National Health Service mental health services team and (iv) aged 18 or over. Main outcome measures: The primary outcome measure was the Adult Suicidal Ideation Questionnaire, which measures suicidal ideation severity over the past month using 25 self-report items. The 6-month follow-up assessment point was the critical time point. There were two secondary suicide measures. Mechanism measures captured six appraisals of emotional difficulties, lack of social support, interpersonal problem-solving difficulties, defeat, entrapment and hopelessness. Results: Recruitment ensued from on 21 June 2017 and lasted until 25 November 2020. The last 12-month follow-up assessment was completed on 10 January 2022. Two hundred and ninety-two participants were randomly allocated to the treatment ( N = 149) and control ( N = 143) groups. Reductions in suicidal ideation severity were not significantly greater in the treatment compared to the control group ( p = 0.07; 95% confidence interval −15.41 to 0.68) at month 6. There were, similarly, no significant treatment effects for the secondary suicide outcomes. A therapy ‘dose–response’ showed that each therapy session reduced the suicidal ideation severity score by 0.46, but this effect was also not significant ( p = 0.056; 95% confidence interval −0.94 to 0.01), nor was a compliance-adjusted analysis in which only participants who attended at least one session of therapy were included ( p = 0.052; 95% confidence interval −0.39 to 0.00). However, a predicted mediation pathway was statistically significant for one of the six mechanism measures, in which the therapy group relative to the control group improved social support appraisals, which, in turn, reduced suicidal ideation severity at month 6 (effect = −2.85, 95% confidence interval −7.00 to −0.23). Qualitative and mixed-methods findings showed that (1) feelings of not mattering, disconnection and irrelevance were central to suicidal thoughts, (2) it is vital to develop better ways of communicating about suicide, (3) our suicide-focused therapy was acceptable and feasible and (4) that being part of suicide work in a trial was largely a positive experience. Limitations: The sample was predominantly White/Caucasian and conducted in one geographical United Kingdom location, the primary outcome measure captured only suicidal thought severity, and there were only two follow-up time points. Conclusions: This suicide-focused psychological intervention did not demonstrate a treatment effect in the primary suicide outcome measure at month 6 at the 5% significance threshold. There was also no significant treatment effect for secondary suicide outcomes. Future work: Research programmes founded on convergent methods, and evidenced-based psychological suicide models are needed to examine how to bolster appraisals of poor social support, disconnection, and not mattering in the context of suicidal mind-sets, and in tandem with the development of creative and inclusive communication tools to relay suicidal experiences. In addition, exploration of the role of ‘dose’ of therapy is crucial for further treatment development. Trial registration: This trial is registered as ClinicalTrials.gov NCT03114917 and ISRCTN17776666. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 13/161/25) and is published in full in Efficacy and Mechanism Evaluation ; Vol. 13, No. 3. See the NIHR Funding and Awards website for further award information.

Objectives Most medication errors occur in primary and long-term care, and a wide range of medication safety interventions have been implemented, but these are often expensive, with little evidence around cost-effectiveness. We report a systematic review of economic evaluations of these interventions within primary and long-term healthcare settings. Methods A comprehensive search was conducted in databases (Medline, Embase, Econlit and PsycINFO) for full economic evaluations of primary care interventions targeting all errors in the medication use process (January 2004 to September 2025). Methodological and reporting qualities were assessed using standard tools. Results From 8523 records, 44 studies evaluating interventions in general/family practice (22), community pharmacy (11) and nursing/care/residential homes (11) met the inclusion criteria, 24 of which were either pharmacy led (19) or multidisciplinary medication reviews (5). All but one study looked at prescribing or monitoring interventions only. A total of 12 studies included all patients, with 24 focusing on older adults (> 65 years) and 3 focusing on condition-specific groups. Most studies only included costs from a healthcare perspective (39). Outcomes ranged from prescribing errors (9), hospital utilisation (13) and health-related quality of life (15) to falls (6) and adverse drug events (6). In total, 21 studies carried out an incremental cost-effectiveness analysis (16 including the incremental cost per quality-adjusted life year gained), and 14 reported the intervention cost-effectiveness. Remaining studies were cost–consequence (18) and cost–benefit analyses (5). Study reporting quality varied considerably, with lack of transparency in the design of the decision-analytic model, varied reporting of costs, little consideration of indirect costs or the impact of loss of trust on future use of healthcare, limitations in handling of uncertainty or discounting and very little patient involvement around targeting patients or designing interventions. Of the ten studies using decision models, all scored poorly for model validation. The quality of studies has not improved over time. Conclusions While some interventions demonstrated cost-effectiveness, study quality was variable, with generally poorly validated models. Study heterogeneity precluded meaningful direct comparison between studies. Significant research gaps remain as studies focused mainly on prescribing and monitoring errors, there was little or no investigation of technology-based interventions and there was inadequate targeting of patients most vulnerable to harm.

Background Pharmacy First, a national community pharmacy service, launched in January 2024 to improve access to primary care for patients with minor conditions facing backlogs caused by the COVID-19 pandemic. Pharmacies are required to share details about their consultations with general practices. We aimed to describe how and what clinical activity was recorded in general practice during the first year of the service. Methods With the approval of NHS England, we conducted a retrospective cohort study using OpenSAFELY-TPP including Pharmacy First consultations between 31 January 2024 and 30 January 2025. We described patient demographics, consultation trends, and the clinical conditions and medications coded with Pharmacy First consultations. Results A total of 402,165 Pharmacy First consultations were recorded for 340,710 patients from a general population of 26,142,380 registered patients in OpenSAFELY-TPP. Acute pharyngitis (28.9%) and uncomplicated urinary tract infection (28%) were the most frequently recorded conditions. By January 2025, 36.3% of Pharmacy First consultations were recorded with a clinical condition, medication, or both. Females, younger adults and those living in more deprived areas were observed more often in Pharmacy First records compared to the general population. Conclusion Increasing recording of the Pharmacy First community pharmacy service was observed in general practice records during its first year, particularly among younger and more deprived populations. However, structured recording of consultation details remains incomplete, limiting evaluation and integration of the service into routine general practice workflows.

Background: Personal narratives describing recovery from mental health problems are widely available to the public. We developed theory on the characteristics and impact of recovery narratives, developed curation procedures for the NEON Collection of 659 recovery narratives and developed and evaluated the NEON Intervention, a theory-informed web application providing access to the NEON Collection. Objectives: To evaluate the effectiveness and cost-effectiveness of the NEON Intervention as compared to usual care and whether this varies by prior health service usage. Design: Three pragmatic parallel-group randomised controlled trials of the NEON Intervention. Intervention arm participants received immediate access. Control arm participants received access after a 52-week follow-up. The effectiveness analysis was a linear regression model of outcome at 52 weeks. The cost-effectiveness analysis compared the incremental cost-effectiveness ratio to the £20,000–30,000 threshold defined in the National Institute for Health and Care Excellence reference case. All analyses were intention-to-treat and baseline-adjusted, with multiple imputation for missing data. Setting: England. Participants: All trials recruited people who were aged 18+ years, resident in England, capable of accessing or being supported to access the internet, able to understand written and spoken English and capable of providing online informed consent. NEON Trial participants also had experience of mental health-related distress in the last 6 months, and psychosis in the previous 5 years. NEON-O (i.e. non-psychosis) Trial participants also had experience of mental health-related distress in the last 6 months, but with no psychosis in the previous 5 years. People identifying as informal carers for people affected by mental health problems but not eligible for the NEON Trial or NEON-O Trial were recruited to the NEON-C feasibility trial. All inclusion criteria were self-rated. Recruitment was from March 2020 to March 2021, through public communications by the central study team, and the work of clinical support officers at 11 secondary care research sites. Interventions: The NEON Intervention has four narrative access mechanisms: theory-informed algorithmic recommendation, random selection, self-selection by narrative category and return to impactful narratives. Participants used the NEON Intervention as much as they wished. Main outcome measures: Primary outcome: quality of life (Manchester Short Assessment). Secondary outcomes: distress, hope, self-efficacy, meaning in life and health status. Results: For the NEON-O (i.e. non-psychosis) Trial, we found a significant baseline-adjusted difference of 0.13 (95% confidence interval 0.01 to 0.26, p = 0.041) in the Manchester Short Assessment score between intervention and control, and a significant baseline-adjusted difference of 0.22 (95% confidence interval 0.05 to 0.40, p = 0.014) in the presence subscale of the Meaning in Life Questionnaire. The incremental cost-effectiveness ratio was £12,526 per quality-adjusted life-year, lower than a threshold of £30,000 per quality-adjusted life-year used for health service commissioning in England. For participants who had used specialist mental health services at baseline, the intervention appeared to reduce cost, although confidence intervals were wide and results were not statistically significant (–£98, 95% credible interval –£606 to £309). It also improved quality-adjusted life-years (0.0165, 95% credible interval 0.0057 to 0.0273) per participant. Hence, for this subgroup of participants, it dominated usual care. For the NEON Trial, no significant baseline-adjusted differences in outcome were found. An incremental cost-effectiveness ratio of £110,501 was found for the NEON Intervention. A subgroup analysis provided preliminary evidence for greater cost-effectiveness for current mental health service users, with an incremental cost-effectiveness ratio of £35,013. The NEON-C Trial showed acceptability and feasibility for informal carers. It recommended integration of carer narratives and creation of an online carer community. Limitations: Participants were recruited during a period in which movement and social interaction were widely affected by the COVID-19 pandemic, with the potential to influence generalisability. For the NEON-O Trial, we had an unrepresentative proportion of female-gendered participants (79.3%). Therefore, our NEON-O Trial findings cannot be generalised. Conclusions: This research programme has shown promising findings from the testing of the NEON Intervention. There is further research to do before implementation can be suggested. Future work: The NEON Intervention should be evaluated through a randomised controlled trial with people experiencing psychosis and using mental health services. The NEON Intervention should be refined to suit the needs of carers and then evaluated through a randomised controlled trial. The NEON-O Trial should be repeated with narrower mental health populations (e.g. mood disorders, eating disorders) to refine knowledge on effectiveness and cost-effectiveness. This may include refining the narrative collection used with these populations. If the NEON Intervention is implemented on a larger scale for people with non-psychosis mental health problems, then studies should be conducted to monitor benefits, continuously assess safety and documentation implementation processes. Future studies should consider alternative forms for presenting recovery narratives, including through multilanguage or multiculture support, and addressing digital exclusion by providing access through widely available technologies, such as smartphones and text messaging. Longitudinal designs are needed to document the short-term, medium-term and long-term impacts of recovery narratives. Trial registration: This trial is registered as NEON Trial ISRCTN11152837, NEON-O Trial ISRCTN63197153 and NEON-C Trial ISRCTN76355273. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref.: RP-PG-0615-20016) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 9. See the NIHR Funding and Awards website for further award information.

Objectives: Interventions that enable people with dementia to retain some independence in activities of daily living (ADL) may delay transitions into residential care and offset sharp reductions in quality of life (QoL). The aim of this study was to estimate how effective a hypothetical intervention needs to be at preserving independence in home‐dwelling people with dementia, to be cost‐effective. Methods: A decision‐analytic model was constructed to compare costs and outcomes of a cohort of people with dementia in the United Kingdom and European Union over a 10‐year period. At model entry, the cohort was distributed across low, moderate, or high levels of dependence. The impact of a hypothetical intervention that preserves independence was evaluated by reducing the proportion of people entering the model with moderate and high dependence. The model included costs for the intervention and health and social care resource use. Secondary analysis included estimated costs of informal care. Health benefit was measured as quality‐adjusted life‐years (QALYs). Results: The cost of the intervention was £570/person. At this cost, an intervention that resulted in 7.5% of the sample entering the model in a lower level of dependence (compared with no intervention) was likely to be cost‐effective (£8690/QALY). An intervention costing £250/person would only need a 2.5% effect and one costing £1000/person would need to have a 10% effect to be potentially cost‐effective. Including informal care costs increased the size of the effect required for the intervention to be cost‐effective because more of the care provided at lower levels of dependence is informal. Conclusions: Preserving independence in people with dementia may be a cost‐effective way to help them live well for longer. Our results provide a guide on costs and required effects for those developing interventions to preserve independence in people with dementia.