Peter S. Blair

BACKGROUND There is a need for new, accessible and effective treatments for eating disorders, including those that address the social impairment many people with eating disorders experience, and previous research has identified that returning to social eating is an important aspect of eating disorder recovery. Virtual Reality (VR) offers opportunities to improve the accessibility of mental health treatments, and there is evidence that VR may be beneficial in the context of eating disorders. Using the Person-based Approach, we have co-developed a VR café intervention, where people with eating disorders can practice challenges related to social eating. OBJECTIVE The aim of this study is to find out whether it is feasible to recruit, retain and follow-up people with eating disorders to receive the intervention in an NHS clinical setting, in addition to their usual treatment. METHODS This study is a mixed-methods single arm feasibility study, with a 3-month follow-up assessment. Thirty participants aged 14-25 who are currently accessing treatment for an eating disorder across two participating NHS trusts will receive up to 6 clinician-supported sessions using the VR café intervention over a period of 6-8 weeks, in addition to their usual treatment. We will measure feasibility outcomes, participant-centred outcomes, VR engagement including eye-tracking data, and participant service use data. A nested qualitative study will be conducted to gain additional insight into the feasibility and acceptability of the intervention. RESULTS Participants are currently being recruited to take part in the study. The last date of possible enrolment will be 29th May 2027. CONCLUSIONS Our co-developed VR café intervention is designed to act as a stepping stone to engaging in social eating situations in the real world, by enabling people with eating disorders to practice skills in a controlled, supported environment with different levels of difficulty, reducing their anxiety and increasing their sense of self-efficacy. Our aim is that the findings of the feasibility study will inform a future randomised controlled trial. CLINICALTRIAL The study was registered on the ISRCTN registry on 23rd April 2026 (registration number: ISRCTN37191564).

Polypharmacy is a major challenge for patient safety and effective resource use. High-quality evidence supporting polypharmacy management is lacking. To develop, optimise and evaluate a primary care complex intervention for reducing medically defined potentially inappropriate prescribing among patients experiencing polypharmacy. Phase 1: Qualitative interviews and focus groups with patients and professionals explored views/experiences of existing National Health Service Scotland interventions, informing development of core intervention components. Phase 2: An external pilot-feasibility study was conducted in five general practitioner practices to optimise the Improving Medicines use in People with Polypharmacy in Primary care intervention. A formative mixed-methods process evaluation examined intervention implementation, alongside evaluating trial processes and collecting data to inform phase 3. Phase 3: A pragmatic, open-label two-arm parallel cluster-randomised trial was conducted in English general practice. The intervention (19 practices) comprised a structured, collaborative and patient-centred approach to medication review, supported by informatics, clinician training, performance feedback and financial incentivisation. The comparator was usual care (18 practices). Up to 50 adults receiving ≥ 5 regular medications, with ≥ 1 indicator of potentially inappropriate prescribing, were reviewed per practice over 6 months. Primary outcome was number of potentially inappropriate prescribing indicators at 26-week follow-up. Secondary outcomes included patient-reported measures and service use. Cost-effectiveness and cost-utility analyses were conducted (primary economic outcome quality-adjusted life-years). A mixed-methods process evaluation (patient surveys, patient/clinician interviews, audio-recorded observations) explored implementation. Phase 1: Intervention component design was informed by findings related to elements of the medication review, informatics and clinician training. Phase 2: Core intervention elements were successfully implemented in the pilot, although clinical delivery was hampered by disruptions due to the coronavirus disease pandemic. Phase 3: Participants were recruited between January and June 2022 (intervention N = 891, usual care N = 836), median age 73 years, 49% female, with median four long-term conditions and eight medications. No improvement in the primary outcome was observed (mean difference potentially inappropriate prescribing count - 0.007; 95% confidence interval -0.21 to 0.199). Treatment burden was slightly improved, and subgroup analysis suggested potential improvements in less complex patients. The process evaluation found general practitioners and pharmacists valued and benefitted from the model of interprofessional collaboration, which strengthened working relationships and provided an opportunity for knowledge sharing and joint decision-making that supported management of clinical uncertainty. Most patients (73.2%) reported satisfaction with the review, with satisfaction strongly associated with perceptions of shared decision-making. There was no evidence of cost-effectiveness, although the economic evaluation did not quantify the aforementioned benefits or other broader factors of potential interest to decision-makers. Key limitations include concurrent changes in usual care, potentially insensitive outcome measures and limited study-population generalisability. A complex medication optimisation intervention did not reduce potentially inappropriate prescribing in patients with polypharmacy. Findings strongly support revisiting current medication optimisation policy, with one-off structured reviews, even when enhanced with digital healthcare solutions and clinical pharmacy investment, not guaranteed to improve key clinical outcomes. Nevertheless, the positive patient and clinician findings are important: protected time for interprofessional collaborative working, plus effective integration of shared decision-making within patient-facing reviews, may facilitate improved patient care more broadly. Research should develop new patient-centred outcomes and identify higher-risk patients. This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number 16/118/14.

Background: Lower urinary tract symptoms are common in older men and can be bothersome, leading to treatment. The UPSTREAM randomised controlled trial (Phase I) investigated whether assessment of these symptoms with invasive urodynamic testing could improve symptoms when guiding treatment options. Objective: To assess the long-term lower urinary tract symptoms and the rates of surgery for bladder outlet obstruction in men participating in the UPSTREAM study (Phase I). Design: Pragmatic, multicentre, parallel-group, two-group open randomised controlled study, with outcome assessors blinded to aggregate data. Setting: Urology departments of 26 National Health Service hospitals in England. Participants: Men ≥ 18 years, seeking further treatment for their bothersome lower urinary tract symptoms, which may include surgery, who were existing participants of the UPSTREAM study (Phase I). Men were excluded if they were unable to pass urine without a catheter, had a relevant neurological disease, were currently undergoing treatment for prostate or bladder cancer, had previous prostate surgery or were unfit for surgery. Interventions: Routine care plus invasive urodynamics (intervention) or non-invasive routine care. Main outcome measures: The primary outcome was a patient-reported International Prostate Symptom Score 5 years post randomisation. Rates of surgery was the key secondary outcome. Patient-reported outcomes included measures of lower urinary tract symptoms, sexual function, overall quality of life and cost-effectiveness from a secondary care perspective. Data sources: Questionnaires to participants for patient-reported outcome measures, and National Health Service England Hospital Episode Statistics and mortality data. Results: Of 820 men randomised in UPSTREAM (Phase I) between October 2014 and December 2016, 211/427 men randomised to the intervention group completed Phase II questionnaires (49.4%) and 205/363 in the routine care group (56.5%). There was no difference found between International Prostate Symptom Scores in the two groups at 5 years (adjusted difference 0.41, 95% confidence interval −1.10 to 1.93). There was also no difference in other lower urinary tract symptoms, sexual function or quality of life. Routine data were received for 98% of men. Three hundred and forty-seven (43.3%) men with routine data available had received at least one related surgical procedure for the treatment of lower urinary tract symptoms. Over the 5-year time horizon, incremental mean costs were slightly higher (£176.63, 95% confidence interval −£464.06 to £817.32) in the intervention group and incremental mean QALYs were slightly lower (−0.039, 95% confidence interval −0.152 to 0.073) in the intervention group. This suggests that routine care is the cost-effective option. Limitations: Around half of the men from Phase I study completed questionnaires at 5 years, although their characteristics were similar to those of non-responders, withdrawn participants or those who had died. The majority of men were of white ethnicity, so results may be less applicable to other ethnicities. Conclusions: Five-year follow-up does not support the introduction of invasive urodynamics in reducing lower urinary tract symptoms or rates of prostate surgery, from a clinical or cost-effectiveness perspective. Future work: This should identify if there are subgroups of patients who might benefit from the addition of urodynamics to routine care for bothersome lower urinary tract symptoms. Trial registration: This trial is registered as ISRCTN56164274. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/140/01) and is published in full in Health Technology Assessment; Vol. 29, No. 26. See the NIHR Funding and Awards website for further award information.

Objective The objective is to determine the incidence of sudden unexplained death in childhood (SUDC) for children aged 1–14 years in England and Wales during 2001–2020. Design Observational study using official national statistics on death registrations and child population. Setting England and Wales. Patients Children dying of SUDC, aged 1–14 years, registered as International Classification of Disease version 10 codes R95–99. Main outcome measures Incidence of SUDC, proportion of child mortality due to SUDC. Results A total of 582 children aged 1–14 years died of SUDC, 450 (77.3%) deaths were in children aged 1–4 years, 55 (9.5%) in those aged 5–9 years and 77 (13.2%) in those aged 10–14 years. The number of SUDC was relatively stable with a mean of 29 cases per year (range 21–38, SD 4.2). Overall child mortality fell from 1482 deaths in 2001 to 826 in 2020. The incidence of SUDC for children aged 1–14 years ranged between 0.002 and 0.004 per 1000. The relative proportion of child mortality due to SUDC increased from 1.96% of all child deaths in 2001 to 3.03% in 2020 (p=0.103), SUDC accounted for 5.8% of deaths of children aged 1–4 years by 2020. At all ages, SUDC was more common in male children than female children. Conclusion The incidence of SUDC has remained static despite overall child mortality almost halving in the last two decades. SUDC is now more widely recognised due to improved investigation, but there has been limited research into SUDC; potential causes and associated risk factors remain unknown. As the relative proportion of child deaths due to SUDC increases, child health professionals must be aware of SUDC to support bereaved families.

Sudden infant death syndrome (SIDS) has been mainly described from a risk perspective, with a focus on endogenous, exogenous, and temporal risk factors that can interact to facilitate lethal outcomes. Here we discuss the limitations that this risk-based paradigm may have, using two of the major risk factors for SIDS, prone sleep position and bed-sharing, as examples. Based on a multipronged theoretical model encompassing evolutionary theory, developmental biology, and cultural mismatch theory, we conceptualize the vulnerability to SIDS as an imbalance between current physiologic-regulatory demands and current protective abilities on the part of the infant. From this understanding, SIDS appears as a developmental condition in which competencies relevant to self-protection fail to develop appropriately in the future victims. Since all of the protective resources in question are bound to emerge during normal infant development, we contend that SIDS may reflect an evolutionary mismatch situation—a constellation in which certain modern developmental influences may overextend the child’s adaptive (evolutionary) repertoire. We thus argue that SIDS may be better understood if the focus on risk factors is complemented by a deeper appreciation of the protective resources that human infants acquire during their normal development. We extensively analyze this evolutionary-developmental theory against the body of epidemiological and experimental evidence in SIDS research and thereby also address the as-of-yet unresolved question of why breastfeeding may be protective against SIDS.

Background: Successful national safer sleep campaigns in the United Kingdom have lowered the death rates from sudden unexpected death in infancy (SUDI) over the past 3 decades, but deaths persist in socioeconomically deprived families. The circumstances of current deaths suggest that improvements in support for some families to follow safer sleep advice more consistently could save lives. Objective: This study aimed to develop and evaluate a risk assessment and planning tool designed to improve the uptake of safer sleep advice in families with infants at increased risk of SUDI. Methods: A co-design approach was used to develop the prototype interface of a web-based tool with 2 parts: an individual SUDI risk assessment at birth and a downloadable plan for safety during times of disruption. The advice contained within the tool is concordant with national guidance from the Lullaby Trust, the United Nations International Children’s Emergency Fund (UNICEF), and the National Institute for Health and Care Excellence. User testing of the prototype tool was conducted by inviting health visitors, midwives, and family nurses to use it with families eligible for additional support. Qualitative interviews with health professionals and families allowed for iterative changes to the tool and for insights into its function and influence on parental behavior. Results: A total of 22 health professionals were enrolled in the study, of whom 20 (91%) were interviewed. They reported appreciating the functionality of the tool, which allowed them to identify at-risk families for further support. They felt that the tool improved how they communicated about risks with families. They suggested expanding its use to include relevance in the antenatal period and having versions available in languages other than English. They reported using the tool with 58 families; 20 parents gave consent to be interviewed by the research team about their experiences with the tool. Families were positive about the tool, appreciated the trustworthy information, and felt that it was useful and appropriate and that the plans for specific infant sleeps would be of benefit to them and other family members. Conclusions: Our tool combines risk assessment and safety planning, both of which have the potential to improve the uptake of lifesaving advice. Refinements to the tool based on these findings have ensured that the tool is ready for further evaluation in a larger study before being rolled out to families with infants at increased risk.

Background: Childhood respiratory tract infections (RTIs) are common and can lead to unnecessary antibiotic use and antimicrobial resistance. The CHIldren with COugh (CHICO) intervention incorporates a clinician-focused algorithm (STARWAVe) to predict future hospitalisation risk, elicitation of carer concerns, and a carer-focused personalised leaflet recording treatment decisions and safety-netting information.Aim: To examine the implementation of the CHICO intervention by primary care clinicians.Design and setting: A qualitative study with primary care clinicians in England taking part in the CHICO randomised controlled trial.Method: Interviews explored the CHICO intervention’s acceptability and use. Clinicians from a range of practices with high and low antibiotic dispensing rates were recruited. Normalisation process theory underpinned data collection and thematic analysis.Results: Most clinicians liked the intervention because it was quick and easy to use, it helped elicit carer concerns, and reassured clinicians and carers of the appropriateness of treatment decisions. However, clinicians used it as a supportive aid for treatment decisions rather than as a tool for behaviour change. The accompanying advice leaflet helped explain treatment decisions and support self-care. The intervention did not always align with clinicians’ usual processes, which could affect use. Increased familiarisation with the algorithm led to reduced intervention use, which was further reduced during the COVID-19 pandemic as a result of changes to practice and remote consultations.Conclusion: Clinicians found the CHICO intervention useful to support decision making around antibiotic prescribing and it helped discussions with carers about concerns and treatment decisions. The intervention may need to be adapted to align more with clinicians’ consultation flow and remote consultations.

Background Clinical uncertainty in primary care regarding the prognosis of children with respiratory tract infections contributes to the unnecessary use of antibiotics. Improved identification of children at low risk of future hospitalisation might reduce clinical uncertainty. A National Institute for Health and Care Research-funded 5-year programme (RP-PG-0608-10018) was used to develop and feasibility test an intervention. Objectives The aim of the children with acute cough randomised controlled trial was to reduce antibiotic prescribing among children presenting with acute cough and respiratory tract infection without increasing hospital admission. Design An efficient, pragmatic open-label, two-arm trial (with embedded qualitative and health economic analyses) using practice-level randomisation using routinely collected data as the primary outcome. Setting General practitioner practices in England. Participants General practitioner practices using the Egton Medical Information Systems® patient-record system for children aged 0–9 years presenting with a cough or upper respiratory tract infection. Recruited by Clinical Research Networks and Clinical Commissioning Groups. Intervention Comprised: (1) elicitation of parental concerns during consultation; (2) a clinician-focused prognostic algorithm to identify children with acute cough and respiratory tract infection at low, average or elevated risk of hospitalisation in the next 30 days accompanied by prescribing guidance, (3) provision of a printout for carers including safety-netting advice. Main outcome measures Co-primaries using the practice list-size for children aged 0–9 years as the denominator: rate of dispensed amoxicillin and macrolide items at each practice (superiority comparison) from NHS Business Services Authority ePACT2 and rate of hospital admission for respiratory tract infection (non-inferiority comparison) from Clinical Commissioning Groups, both routinely collected over 12 months. Results Of the 310 practices required, 294 (95%) were recruited (144 intervention and 150 controls) with 336,496 registered 0–9-year-olds (5% of all 0–9-year-old children in England) from 47 Clinical Commissioning Groups. Included practices were slightly larger than those not included, had slightly lower baseline dispensing rates and were located in more deprived areas (reflecting the distribution for practice postcodes nationally). Twelve practices (4%) subsequently withdrew (six related to the pandemic). The median number of times the intervention was used was 70 per practice (by a median of 9 clinicians) over 12 months. There was no evidence that the antibiotic dispensing rate in the intervention practices [0.155 (95% confidence interval 0.135 to 0.179)] differed to controls [0.154 (95% confidence interval 0.130 to 0.182), relative risk= 1.011 (95% confidence interval 0.992 to 1.029); p = 0.253]. There was, overall, a reduction in dispensing levels and intervention usage during the pandemic. The rate of hospitalisation for respiratory tract infection in the intervention practices [0.019 (95% confidence interval 0.014 to 0.026)] compared to the controls [0.021 (95% confidence interval 0.014 to 0.029)] was non-inferior [relative risk = 0.952 (95% confidence interval 0.905 to 1.003)]. The qualitative evaluation found the clinicians liked the intervention, used it as a supportive aid, especially with borderline cases but that it, did not always integrate well within the consultation flow and was used less over time. The economic evaluation found no evidence of a difference in mean National Health Service costs between arms; mean difference −£1999 (95% confidence interval −£6627 to 2630). Conclusions The intervention was feasible and subjectively useful to practitioners, with no evidence of harm in terms of hospitalisations, but did not impact on antibiotic prescribing rates. Future work and limitations Although the intervention does not appear to change prescribing behaviour, elements of the approach may be used in the design of future interventions. Trial registration This trial is registered as ISRCTN11405239 (date assigned 20 April 2018) at www.controlled-trials.com (accessed 5 September 2022). Version 4.0 of the protocol is available at: https://www.journalslibrary.nihr.ac.uk/ (accessed 5 September 2022). Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (NIHR award ref: 16/31/98) programme and is published in full in Health Technology Assessment; Vol. 27, No. 32. See the NIHR Funding and Awards website for further award information.