Artificial intelligence (AI) is rapidly evolving, offering an expanding suite of capabilities that go beyond the traditional focus on prediction and classification. Generative AI (GenAI) and agentic AI could create transformative practices to support real-world evidence (RWE) generation for health research by streamlining studies, accelerating insights and improving decision-making. However, there is no published overview available describing the range of applications in RWE generation. This review aims to describe where and how genAI and agentic AI are applied across the domains of healthcare research tasks for RWE generation. Additionally, to map applications by tasks and methods across the product lifecycle continuum, and to identify emerging gaps and opportunities.

This Living Scoping Review (LSR) will include studies reporting an application and/or evaluation of genAI or agentic AI applied to one or more RWE generation research tasks. Searches will be conducted in Embase, MEDLINE and additional sources (eg, grey literature). Citations will be independently screened by two human senior reviewers for a substantive training dataset and a commercially available screening algorithm (Robot Screener) will complete screening with a human reviewer. The LSR will include reports of studies (primary or reviews) describing and/or evaluating the application of any genAI model for RWE generation in healthcare, in English, published from 1 January 2025 to the date of search. Data will be extracted from all studies included in the LSR by one independent senior reviewer using a piloted template, with 10% quality check by a second senior reviewer. Descriptive statistics will be used to summarise the applications of genAI per RWE research task, and the results of genAI evaluations. Thematic analysis will be used to describe genAI application patterns, trends, gaps and opportunities. The LSR protocol and reports will be updated annually, and findings will be published on a publicly available website (eg, ISPE—the International Society for Pharmacoepidemiology).

Ethical approval is not required due to use of previously published data. Planned dissemination includes peer-reviewed publication, presentation and short summaries.

Spinal cord injury (SCI) affects over 18 000 individuals annually, leading to significant motor and autonomic dysfunctions that reduce quality of life (QoL). Epidural spinal cord stimulation (eSCS) has shown potential in restoring function in chronic individuals with SCI. However, research on cervical and autonomic dysfunction-related SCI remains limited. This study will assess the safety and efficacy of eSCS in improving autonomic and volitional functions, as well as truncal stability, bowel, bladder and sexual function, and overall QoL.

The study is a phase I/II trial in which participants will serve as their own controls. The Abbott Eterna epidural stimulator system will be implanted, and assessments will occur every 3 months. The study will be conducted over a period of 4 years. A total of 36 participants will be enrolled and followed for 1 year.

Bayesian optimisation will be used to determine the most effective stimulation settings, with 15 settings programmed at the end of each visit.

Food and Drug Administration and University of Minnesota Institutional Review Board approvals have been secured for the study. Interim reports will be made available through peer-reviewed journals, conference presentations and clinical network reporting.

CE-STAND (Cervical Epidural STimulation After Neurological Damage) seeks to advance SCI treatment by expanding eSCS applications in chronic cervical SCI, improving patient outcomes and reducing healthcare costs. Future studies could consider a larger sample size, long-term safety, matched-control and randomisation.

NCT06410001

To evaluate the criterion validity and test–retest reliability of the Chinese version International Physical Activity Questionnaire-Short Form (cIPAQ-SF) for assessing sedentary behaviour and physical activity (PA) in overweight and obese Chinese adults, using activPAL as the reference.

A cross-sectional study was conducted at a Clinical Nutrition Clinic in China. Participants completed the cIPAQ-SF before and after wearing an activPAL for 7 consecutive days. Criterion validity was assessed using Pearson’s/Spearman’s correlation coefficients and Bland-Altman plots for sitting time (hours/day), moderate, vigorous and moderate-to-vigorous PA (MVPA) (min/week). Sensitivity and specificity evaluated the IPAQ-SF’s accuracy in identifying those not engaging in any PA and those not meeting the PA recommendation (MVPA ≥150 min/week). Test–retest reliability was assessed using intraclass correlation (ICC).

Among 80 participants (age 33.9±7.3 years; body mass index 29.1±4.5 kg/m²), the IPAQ-SF demonstrated moderate criterion validity for sitting time (r=0.577 on weekdays, r=0.444 on weekends) and MVPA (=0.451) compared with activPAL. It underestimated sitting time by 3.5 hours/day on weekdays and 2.9 hours/day on weekends. The cIPAQ-SF showed moderate-to-high sensitivity for correctly identifying individuals who were not engaging in any PA (53.6%–85.7%) or not meeting PA recommendations (93.8%), but its specificity was low to moderate (47.8%–73.7%) for PA engagement and meeting guidelines (55.2%). Test–retest reliability was moderate for sitting time (ICC=0.549–0.614) and poor to moderate for PA levels (ICC=0.453–0.592).

The IPAQ-SF demonstrates moderate validity and reliability in assessing sedentary behaviour and insufficient PA among overweight and obese Chinese adults. It can be used to identify physically inactive individuals for targeted interventions and monitor changes in sedentary behaviour.

Migrants are vulnerable to structural barriers that compromise their health status and simultaneously decrease their access to healthcare, including palliative care. Literature on palliative care access in migrant populations is limited by a focus on migration to high-income countries; under-representation of refugees, asylum seekers and migrant workers; and no investigation of intersectional factors. We seek to conduct a scoping review of palliative care utilisation in migrant populations, including both academic and grey literature, including articles from low- to middle-income countries and about refugees, asylum seekers and migrant workers. The review will map out what is already known and what remains unknown about palliative care utilisation in migrants; identify the factors associated with palliative care utilisation; and determine the extent to which intersectionality has been examined.

This scoping review will adhere to the methodological framework developed by the Joanna Briggs Institute, and reporting will be in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews reporting guidelines. A search strategy developed by a health sciences librarian will be conducted on Ovid MEDLINE, Embase, CINAHL and PsycINFO in addition to grey literature sources up to 7 July 2025. Articles will be included if they studied migrant populations and reported on palliative care utilisation. Two independent reviewers will screen titles and abstracts and review full texts. Data extraction will be performed independently and in duplicate using a standardised, pilot-tested form. Findings will be synthesised thematically, with particular attention to countries of destination, migrant subgroups and intersectional factors.

Since this is a scoping review and uses only previously published data, it does not require approval by a research ethics board. Findings will be disseminated as an abstract for presentation at a palliative care conference and a manuscript for publication in a peer-reviewed journal.

Open Science Framework (gy75v).

Documenting evidence on global health strategies and programmes that provide safeguards for vulnerable populations and strengthen overall pandemic preparedness is essential. This study aimed to identify factors associated with adherence to COVID-19 mitigation measures, COVID-19-related symptoms and testing, as well as pandemic-related income loss among internally displaced persons (IDPs) in urban and remote areas of Burkina Faso, Niger and Mali.

This cross-sectional study used fixed-site respondent-driven sampling (RDS).

Primary care settings across six urban and remote locations in Burkina Faso, Mali and Niger.

4144 internally displaced adults, who had been forced from their homes within 5 years of the survey, participated in the study. The survey was conducted between August and October 2021 in two selected locations in three countries: Kaya (n=700) and Ouahigouya (n=715) in Burkina Faso; Bamako (n=707) and Ménaka (n=700) in Mali; and Niamey (n=733), and Diffa (n=589) in Niger. Participants were included if they were born in the study countries, displaced due to conflict, violence or disaster, aged 18 years or older, and living or working in the study site for at least 1 month.

The primary outcomes measured were adherence to COVID-19 mitigation measures, presence of COVID-19 symptoms, COVID-19 testing and vaccination rates and pandemic-related income loss.

Among 4144 IDPs surveyed across 6 sites in Burkina Faso, Mali and Niger, over half (52%) reported experiencing at least one COVID-19 symptom in the preceding 2 weeks. However, 8% had ever been tested for COVID-19, and fewer than 5% had received a vaccine in all sites except Diffa, where 54% reported vaccination. While willingness to be vaccinated was high (ranging from 56.6% in Bamako to 89.5% in Niamey), access remained limited. Compliance with public health measures varied; for example, 41.7% of IDPs were able to maintain physical distance from non-household members, and just 60.2% reported wearing a mask. Chronic health conditions were consistently associated with higher odds of COVID-19 symptoms (Ménaka OR: 14.65; 95% CI: 7.36 to 29.17). Economic vulnerability was widespread, with more than half of IDPs in Bamako (58.1%) and Niamey (66.4%) reporting income loss due to the pandemic, and average monthly income declining by over 50% in most sites. IDPs in urban areas generally reported greater exposure to COVID-19 risk factors, while those in remote settings reported lower adherence and poorer access to basic preventive measures.

This is the first known RDS study to explore the impact of the COVID-19 pandemic on IDPs. Findings suggest that IDPs in urban areas may face heightened risks of exposure and infection, underscoring the need to prioritise them in public health efforts. Low testing and vaccination rates and significant income loss call for advocacy and economic relief to address these vulnerabilities. Future pandemic responses should integrate health interventions with targeted support, especially mitigating income loss to bolster IDPs’ resilience.

Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving patient outcomes. International guidelines recommend hospital sepsis screening programmes, which are commonly implemented in the electronic health record (EHR) as an interruptive sepsis screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care.

The Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC) master protocol will study two distinct populations in separate trials: emergency department (ED) patients (SEPTIC-ED) and inpatients (SEPTIC-IP). The SEPTIC trials are pragmatic, multicentre, blinded, randomised controlled trials, with equal allocation to compare four SIRS-based sepsis screening alert groups: no alerts (control), nurse alerts only, prescribing clinician alerts only, or nurse and prescribing clinician alerts. Randomisation will be at the patient level. SEPTIC will be performed at eight acute-care hospitals in the greater New York City area and enrol patients at least 18 years old. The primary outcome is the percentage of patients with completion of a modified Surviving Sepsis Campaign (SSC) hour-1 bundle within 3 hours of the first SIRS alert. Secondary outcomes include time from first alert to completion of a modified SSC hour-1 bundle, time from first alert to individual bundle component order and completion, intensive care unit (ICU) transfer, hospital discharge disposition, inpatient mortality at 90 days, positive blood cultures (bacteraemia), adverse antibiotic events, sepsis diagnoses and septic shock diagnoses.

Ethics approval was obtained from the Columbia University Institutional Review Board (IRB) serving as a single IRB. Results will be disseminated in peer-reviewed journal(s), scientific meeting(s) and via social media.

ClinicalTrials.gov: NCT06117605 and NCT06117618.

Time-lapse imaging (TLI) systems for embryo incubation and assessment are hypothesised to improve the success rates of in vitro fertilisation (IVF) treatment by providing undisturbed culture conditions for embryos and/or providing more information on embryo development (morphokinetic parameters) to improve predictive accuracy for embryo selection. Despite numerous aggregate meta-analyses showing uncertainty of benefit, IVF clinics globally continue to invest significant resources into this technology with little translation of evidence into guidelines or policy frameworks. This may be attributed to heterogeneity in participant populations and/or variations in the use of TLI, as highlighted in the aggregate meta-analyses.

Our research proposal for evidence synthesis using individual participant data meta-analysis will provide greater power than aggregate meta-analysis to detect differential treatment effects for effectiveness (live birth, clinical pregnancy) and safety (pregnancy loss, multiple births, congenital malformations) outcomes across three comparisons (overall effect, undisturbed culture and morphokinetic parameters). We will also analyse if there are specific subgroups of women who may benefit from the intervention and if variations in use of the intervention show any benefits. We have incorporated the results of the literature search used for the latest Cochrane review (7 January 2019) into this review and will include all the trials included therein. We will further update the literature search to include new evidence by searching the electronic databases MEDLINE, EMBASE, CINAHL and CENTRAL from 07/01/2019 to date, outcomes for all ongoing trials reported in the 2019 Cochrane review, trial registers for newer ongoing/completed trials and the citation lists of all the newly identified trials for any relevant references. The search strategy will include a combination of subject headings and text words relating to or describing the participants and the intervention, with no language restrictions. Two authors will independently screen the titles and abstracts, and full text of articles retrieved from the search, to finalise a list of trials suitable for inclusion in the review. We will include randomised controlled trials that assess TLI systems for either undisturbed culture and/or use of morphokinetic parameters for embryo selection in women having IVF/ICSI treatment using their own oocytes.

Ethical approval is not required for this study. We plan to disseminate the findings of the research to all stakeholders, including the National Institute for Health and Care Excellence and other international guideline development groups, through publication in peer-reviewed journals, presentation at conferences, newsletters, meetings and websites of the funders, fertility charities and patient support groups.

CRD42024564332.