The growing advancement of innovative stem cell technologies requires careful evaluation of their economic, clinical and societal impacts. Early economic evaluations are essential for developing new medical technologies and supporting key decisions about commercialisation and market access. This scoping review explores Early Health Technology Assessment (eHTA) approaches specifically related to human stem cell technologies. By examining how eHTA can support the commercialisation of these therapies, we aim to clarify its role in optimising resource allocation and enhancing both the clinical and societal benefits of stem cell technologies.

To explore the use of eHTA in the development of stem cell-related technologies, a scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses - Scoping Review Extension guidelines. Systematic searches were conducted across scientific databases (MEDLINE, International HTA database, EconLit, PAIS Index and EconPapers), grey literature sources (Overton) and through hand-searching to identify eligible articles published from inception to 14 April 2026. No limits were imposed on language. Reviewers will independently record data from eligible studies using a standard data abstraction form. The gathered information will be synthesised both quantitatively and narratively.

Formal ethical approval is not required, as this study does not involve the collection of primary data. The findings will be shared through professional stem cell networks, published in national and international health technology assessment conference proceedings and submitted for open-access, peer-reviewed publication.

Despite the rapid increase in the proportion of unmarried women in the Chinese population, little is known about their sexual and reproductive health (SRH) and well-being. The aim of this survey is to collect data on SRH knowledge and needs, past care-seeking experiences, fertility goals and attitudes towards fertility technology among unmarried women in four megacities in China where singlehood is prominent among women of reproductive age.

This multi-centre cross-sectional survey, Survey of Unmarried women on Reproductive health and Fertility (SURF), aims to recruit 6000 eligible women, with 1500 from each study site. Eligibility criteria include: (1) women; (2) aged 25–40 years; (3) currently unmarried (never married, divorced or widowed); and (4) reside in Beijing, Shanghai, Shenzhen or Guangzhou metropolitan areas. Quota sampling is used to ensure the age strata in the final sample correspond to the age distribution from the latest Chinese census. Data are currently being collected through referral recruitment and a self-administered questionnaire available on the mobile devices and computers of participants.

SURF has been approved by the Biomedical Ethics Committee of Peking University (institutional review board (IRB) number: IRB00001052-24040). Each participant receives comprehensive information about the objectives, procedure and data handling of the survey before proceeding to the questionnaire. Participants are also provided with the contact information of the principal investigator in case they have questions regarding the survey. Written informed consent is obtained before data collection starts. Participation is anonymous and no personal identifiers are collected. Findings from this survey will be disseminated through peer-reviewed journals and at scientific conferences.

Co-design of the PREDICT-Kidney online tool by patients, members of the public and healthcare professionals (HCPs), to support the communication of the risk of recurrence following surgical treatment for kidney cancer.

Qualitative co-design study. Using an iterative process, feedback was collected (via workshops), prioritised and implemented.

Online workshops with participants from across the UK were conducted between December 2023 and November 2024.

18 adult participants, including patients surgically treated for kidney cancer, members of the public without a history of kidney cancer and HCPs involved in kidney cancer care.

To produce an online tool to support the communication of risk of kidney cancer recurrence that is easy to use, easy to understand and acceptable to stakeholders. Secondary outcomes are the properties of the feedback collected, including volume and type.

Across nine workshops, 99 discrete feedback items were collected, resulting in 71 actionable changes to the initial prototype tool. Differences in priorities were observed between participant groups, especially around the inclusion of information about competing risks of death. Participants valued the tool for improving consistency of follow-up information, supporting shared decision-making and providing multiple visual formats to communicate risk. Iterative feedback led to refinements in terminology, design, content and delivery, including adjustments to the presentation of recurrence and mortality risk.

A co-design approach was used to improve the PREDICT-Kidney online tool to align with the needs of patients and HCPs. A feasibility study is required to evaluate its use and impact in clinical practice.

Shared decision-making is widely advocated in policy and practice, but how it is to be applied in a high-stakes clinical decision such as major lower limb amputation due to chronic limb-threatening ischaemia or diabetic foot is unclear. The aim of this study was to explore the communication, consent, risk prediction and decision-making process in relation to major lower limb amputation.

A qualitative study (done as part of a broader mixed-methods study) using semi-structured interviews. Interview transcriptions were analysed using thematic analysis.

Vascular centres in three large National Health Service hospitals in Wales and England, UK, between 1 October 2020 and 30 September 2022.

A purposive sample of 18 patients for whom major lower limb amputation was considered as a treatment option/carried out, with interviews conducted before or within 4 months of amputation and 4–6 months after amputation. A further purposive sample of 20 healthcare professionals (including eight surgeons) involved in supporting or conducting major lower limb amputation decision-making.

Five major categories were identified that highlighted the challenges of ensuring shared decision-making associated with major lower limb amputation: (i) patients’ limited understanding, (ii) variable patient attitudes to decision-making, (iii) healthcare professionals’ perceived challenges to sharing decision-making, (iv) surgeons’ paternalism and (v) patients’ and healthcare professionals’ decisional regret/possible consequences of challenges.

Amputation is a life-changing decision for both patients and healthcare professionals, with huge consequences. Despite being considered the gold standard, our findings highlight several challenges to effective shared decision-making for major lower limb amputation. Shared decision-making training for healthcare professionals is paramount if these limitations are to be addressed and patients are to feel confident in being adequately informed about the treatment decisions that they make.

NCT04903756.

To compare costs and health consequences and to assess the cost-effectiveness of using low-dose oral long-acting morphine in people with chronic breathlessness.

Within-trial planned cost-consequences and cost-effectiveness analysis of data from a multisite, parallel-group, double-blind, randomised, placebo-controlled trial of low-dose, long-acting morphine.

11 hospital outpatients across the UK.

Consenting adults with chronic breathlessness due to long-term cardiorespiratory conditions.

5–10 mg two times a day oral long-acting morphine with a blinded laxative for 56 days.

Mean and SD of healthcare resource use (HRU) by trial arm; mean differences and 95% CI of costs between trial arms.

Mean differences in 28- and 56-day quality-adjusted life years (QALYs based on EuroQol five-dimension five-level score), Short Form-six dimensional scores and ICEpop CAPability-Supportive Care Measure scores; cost-utility of long-acting morphine for chronic breathlessness.

143 participants (75 morphine and 67 placebo) were randomised; 140 (90% power, males 66%, mean age 70.5 (SD 9.4)) formed the modified intention-to-treat population (participants receiving at least one dose of study medication). There were more inpatient and fewer outpatient services used by the morphine group versus the placebo. In the base-case analysis at 56 days, long-acting morphine was associated with similar mean per-patient costs and QALYs. There was an increase of £24 (95% CI –£395 to £552) and 0.002 (95% CI –0.004 to 0.008) QALYs. Hospitalisations were the main driver of cost differences. The corresponding incremental cost-effectiveness ratio was £12 000/QALY, with a probability of cost-effectiveness of 54% at a £20 000 willingness-to-pay threshold. In the scenario analysis that excluded costs of adverse events considered unrelated to long-acting morphine by site investigators and researchers, the probability of cost-effectiveness increased to 73%.

Oral morphine for chronic breathlessness is likely to be a cost-effective intervention provided adverse events are minimised, but the effect on outcome is small and cautious interpretation is warranted.

ISRCTN87329095.

Fibrosis is a pathological feature that can occur in a wide range of diseases including diabetes mellitus. We investigated whether in people with type 1 (T1DM) or type 2 diabetes mellitus (T2DM), glycaemia or diabetes-related complications are associated with fibrotic diseases.

Retrospective cohort study using UK Clinical Resource Datalink (CPRD) Aurum and Hospital Episode Statistics.

We included people with prevalent T1DM or T2DM as of 31 December 2015 (recorded in CPRD Aurum), eligible for linkage with Hospital Episode Statistics and followed up for 3 years.

We defined diabetes status using blood/urine biomarkers and complications. In the T2DM cohort, we also investigated exposures of hyperglycaemia, insulin resistance and metformin prescription. Fibrotic condition diagnoses were determined from both primary and secondary care records. Logistic regression analyses were undertaken to understand the strength of association between diabetes status/diabetic complications and fibrotic conditions, respectively.

The T1DM cohort consisted of 9669 people while the T2DM cohort included 504 066 people. In T1DM, we found that albuminuria was associated with lung fibrosis (ORadj: 2.07, 99% CI 1.35 to 2.17), and microvascular complications were associated with atherosclerosis (ORadj: 1.81, 99% CI 1.18 to 2.77) and cardiomyopathy (ORadj 1.53, 99% CI:1.15 to 2.04). In the T2DM cohort, both glycaemia above target and diabetes complications were associated with most fibrotic conditions.

Within the T1DM population, no consistent association between diabetes status and all fibrotic diseases was observed. More research is required to understand whether the association between diabetes complications and fibrotic diseases is due to shared risk factors or whether glycaemia in T2DM may be influenced by fibrotic pathology.

Studies suggest that extreme heat events can have negative effects on mental health. However, characterisation of these effects in urban communities remains limited, and few studies have investigated the potential modifying effects of demographic, clinical and environmental characteristics. The aim of this study is to address this knowledge gap and quantify the impacts of extreme heat on mental health, health service use and mental well-being in vulnerable urban populations.

In this multidisciplinary project, we will assess mental health outcomes in different populations by bringing together two distinct datasets: electronic health record (EHR) data on mental health service users and data from general public participants of Urban Mind, a citizen science project. We will use EHRs from the South London and Maudsley NHS Foundation Trust (SLaM) and the North London NHS Foundation Trust (NLFT), from six boroughs which collectively cover more than 1.8 million residents in Greater London, to capture mental health service use and mortality among people with existing diagnoses of mental illness across 2008–2023. We will use smartphone-based ecological momentary assessment data from Urban Mind to measure mental well-being in the general population (2018–2023). These datasets will be linked to high-resolution spatiotemporal data on temperature, fine and coarse particulate matter (PM_2.5, PM₁₀), nitrogen dioxide (NO₂), Normalised Difference Vegetation Index (NDVI) and density of large mature tree canopy. We will employ novel quasi-experimental designs, including case time series and case-crossover analysis, to examine the impact of extreme heat on mental health and explore effect modification by sociodemographic, clinical and environmental factors, including air pollution and types of green space coverage. We will also develop a microsimulation model combined with the InVEST urban cooling model to assess and forecast the mental health and social care impacts of extreme heat events and the mitigation of these impacts by different green space coverage and pollution-reduction policies. With a core team composed of researchers, community organisations, industry partners and specialist policy experts, this project will consider lived experience, benefit from broad stakeholder engagement and address gaps in policy and practice.

Each component of this project has been approved by the relevant ethics committee (ref RESCM-22/23-6905 for Urban Mind, LRS/DP-23/24-41409 for the co-development of a screening tool, 23/SC/0257 for the SLaM EHRs, and 24/EE/0178 for the NLFT EHRs). Our dissemination plan includes peer-reviewed scientific articles, policy briefs, a practical guide on fostering ecological and human resilience at the neighbourhood level, and a technical guide for planting and improving the growing conditions of large canopy trees.

Care (Education) and Treatment Reviews (C(E)TRs) are intended to reduce unnecessary psychiatric hospital admission and length of stay for people with intellectual disability and autistic people. The use and impact of C(E)TRs have not been systematically evaluated since their introduction in England in 2015. The aims of this study are to describe the demographic and clinical profiles of people who receive a community C(E)TR and to investigate their effects on admission, length of hospital stay and clinical and functional change.

We will conduct a retrospective cohort study using de-identified data from electronic health records derived from two large National Health Service mental health providers in London, England, including one replication site. Data will be extracted using the Clinical Record Interactive Search (CRIS) tool for all people with recorded intellectual disability and/or autism who received mental healthcare from 2015. We will identify community C(E)TR events using keyword searches. Community C(E)TRs will be examined in two ways: (1) In a community cohort, we will capture data in the 6-month periods before and after a community C(E)TR and compare this to a matched control group and (2) In a hospital cohort, we will compare groups who did and did not receive a community C(E)TR prior to their admission. We will describe the socio-demographic and clinical profiles of each group and their health service use, and compare C(E)TR and no C(E)TR groups using t-tests (or a non-parametric equivalent). The primary outcomes are admission to a psychiatric hospital (community cohort) and length of psychiatric hospital admission and clinical change (hospital cohort). Admission to psychiatric hospital will be estimated using propensity score weighting and difference-in-differences methods. Cox’s proportional hazard model will be used for length of hospital admission and repeated-measures analysis of variance (ANOVA) will be used to assess clinical change.

Use of CRIS to examine de-identified clinical data for research purposes has overarching ethical approval. This study has been granted local approval by the South London and Maudsley CRIS Oversight Committee. Findings will be disseminated in an open-access peer-reviewed academic publication, at conference presentations, and to service users and carers in accessible formats.

Structural MRI of the brain is routinely performed on patients referred to memory clinics; however, resulting radiology reports, including volumetric assessments, are conventionally stored as unstructured free text. We sought to use natural language processing (NLP) to extract text relating to intracranial volumetric assessment from brain MRI text reports to enhance routine data availability for research purposes.

Electronic records from a large mental healthcare provider serving a geographic catchment of 1.3 million residents in four boroughs of south London, UK.

A corpus of 4007 de-identified brain MRI reports from patients referred to memory assessment services. An NLP algorithm was developed, using a span categorisation approach, to extract six binary (presence/absence) categories from the text reports: (i) global volume loss, (ii) hippocampal/medial temporal lobe volume loss and (iii) other lobar/regional volume loss. Distributions of these categories were evaluated.

The overall F1 score for the six categories was 0.89 (precision 0.92, recall 0.86), with the following precision/recall for each category: presence of global volume loss 0.95/0.95, absence of global volume loss 0.94/0.77, presence of regional volume loss 0.80/0.58, absence of regional volume loss 0.91/0.93, presence of hippocampal volume loss 0.90/0.88, and absence of hippocampal volume loss 0.94/0.92.

These results support the feasibility and accuracy of using NLP techniques to extract volumetric assessments from radiology reports, and the potential for automated generation of novel meta-data from dementia assessments in electronic health records.

The Episodic Disability Questionnaire (EDQ) was developed to measure the presence, severity and episodic nature of disability experienced among persons with chronic conditions. Our aim was to assess the sensibility, utility and implementation considerations of the EDQ among older adults with complex health needs.

Cross-sectional measurement study involving quantitative and qualitative methods of data collection.

We recruited community-dwelling older adults (65 years of age or older) living with complex health needs receiving care from a primary healthcare team in Toronto, Canada.

We administered the EDQ, sensibility questionnaire (assessing face and content validity, and ease of usage, with each item scored from 0 to 7 with greater scores indicating greater sensibility) and demographic questionnaire, followed by a semi-structured interview in the home or clinical setting. Using an interview guide, we asked participants about their perspectives on utility, format and implementation of the EDQ in clinical practice. We considered the EDQ sensible if the median score on the sensibility questionnaire was ≥5/7 for ≥80% of items and if none of the items had a median score of ≤3/7. We conducted a team-based directed content analysis of the interview transcripts.

The median age of the 11 participants in this study was 83 years of age. All participants reported living with two or more chronic health conditions, with osteoarthritis (n=5) and diabetes (n=4) most frequently reported. The EDQ met the criterion for sensibility as measured by the sensibility questionnaire. Interview data from participants (n=10) indicated that the EDQ represents the health-related challenges among this sample of older adults with complex health needs, captures the episodic nature of disability and was easy to use. Utility of the EDQ included providing clinicians with a holistic understanding of health challenges older adults face, aiding in intervention planning and measuring changes in disability over time. Six of the participants also expressed uncertainty as to how the EDQ specifically could be used by clinicians in their care. Considerations for implementation included mode of administration (paper or electronic) and the importance of communicating EDQ scores with older adults based on individual preferences.

The EDQ possesses sensibility and utility for use among this sample of older adults living with complex health needs in home or clinical care settings.