Postoperative pain is common, with approximately one-third of surgical patients experiencing severe acute pain and 10–20% developing chronic post-surgical pain (CPSP). Evidence shows that female patients are at higher risk of pain after sex non-specific surgery, thus sex- or gender-specific differences in pain treatment efficacy with potential consequences for perioperative pain management are to be expected. Considering the clinical and societal burden of poorly managed postoperative pain, the GEPard project comprises two systematic reviews, GEPard 1: sex- and/or gender-specific differences in efficacy of perioperative pain management for certain (major) surgical procedures in adult patients; and GEPard 2: sex- and/or gender-specific differences in the dosing, efficacy and adverse effects of the most common systemic perioperative non-opioid- and co-analgesics across all sex non-specific surgical procedures in adult patients.

The reviews will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Cochrane Handbook. MEDLINE, Embase, Cochrane Library, Web of Science, Scopus, ClinicalTrials.gov and PsycINFO will be searched. We will include randomised controlled trials (RCTs) and systematic reviews/meta-analyses reporting outcomes disaggregated by sex and/or gender in adult surgical patients. For GEPard 1, this applies to selected major surgical procedures; for GEPard 2, to all non-sex-specific surgical procedures. Interventions include regional anaesthesia, systemic analgesics and psychological strategies for GEPard 1 and non-opioid- as well as co-analgesics for GEPard 2. Two reviewers will independently screen and extract the data. Cochrane Risk of Bias Tool 2.0 (RoB 2) and AMSTAR 2 tools will assess study quality. Random-effects or Bayesian meta-analyses will be performed where possible; otherwise, narrative synthesis will be applied. GRADE methodology will assess evidence certainty.

No ethical approval is required for these reviews. Findings will be disseminated via peer-reviewed publications, patient organisations and professional societies. Data will be shared via Zenodo or Open Science Framework (OSF), following FAIR principles.

The systematic review protocols for both reviews have been registered in PROSPERO on 29 August 2025 (Registration-ID: CRD420251121393 (GEPard1), CRD420251121536 (GEPard2).

Studies have demonstrated the positive impact of falls prevention interventions for high-risk older adults who have experienced a severe fall. However, uptake and adherence rates remain low. The purpose of this study is to assess the capabilities, opportunities and motivations of older adults following a fall with subsequent presentation to the emergency department and direct discharge home in relation to falls prevention measures.

This study, conducted as part of the ‘Sentinel fall presenting to the emergency department’ project at the Carl von Ossietzky University Oldenburg in Germany, involved a participatory research team (PRT). It was a qualitative study based on focus group interviews undertaken between June and October 2022, analysed in accordance with qualitative content analysis following Kuckartz. The Theoretical Domains Framework forms the basis of the deductive category system. PRT members collaborated as co-researchers in conducting and analysing the focus groups.

12 focus groups were conducted (N=52). The participants were older adults (≥60 years) who had received outpatient care in an emergency department following a fall (N=41) and their relatives (N=11).

Interviewees indicated that both knowledge of available support options and the ability to self-evaluate are important following a fall. Additionally, health circumstances, such as limitations resulting from fall-related consequences, influence the adoption of falls prevention measures. Social influences, as well as environmental context and resources, were also discussed, reflecting participants’ preferences for intervention design, such as having a central point of contact and specific courses on fall training. Moreover, the fall event itself may strengthen the perceived need for preventive measures, whereas a fear of falling can lead to reduced or modified activity levels.

To improve the engagement of older adults in falls prevention interventions following a fall, the establishment of a central point of contact could be considered. Individual tailored interventions, including psychological support as well as specific fall training, are needed.

DRKS00025949.

Low anterior resection syndrome (LARS) is a common functional complication after sphincter-preserving surgery for rectal cancer that significantly impairs the quality of life. Current postoperative management strategies are suboptimal, and effective preventive approaches are lacking. This study aims to evaluate the impact of a mobile-based, knowledge-enhanced digital intervention for reducing the incidence of major LARS.

This is a multicentre, open-label, parallel-group, randomised controlled trial to be conducted across three academic medical centres in Korea.

A total of 300 adult patients who underwent low anterior resection or stoma reversal after rectal cancer surgery will be randomly assigned in a 1:1 ratio to the intervention group (mobile digital programme) or the control group (standard educational materials). The digital programme includes daily symptom monitoring, exercise suggestions, dietary recommendations and structured feedback from healthcare providers during clinical visits based on outcomes. The primary outcome is the incidence of major LARS (score ≥30) at 12 months postoperatively. Secondary outcomes include longitudinal changes in LARS score, quality of life (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30), EORTC QLQ-Colorectal Cancer 29 (CR29)), European Quality of Life 5 Dimensions Level Version (EQ-5D-5L), patient satisfaction and programme adherence. Statistical analyses will include stratified chi-squared tests and mixed-effects models based on the intention-to-treat principle.

The trial received ethical approval from the Institutional Review Board of the National Cancer Centre, Korea. Written informed consent will be obtained from all participants. The findings will be disseminated through peer-reviewed publications and conference presentations.

NCT07041515.

In the last 60 years, newborn bloodspot screening (NBS) has expanded as a public health intervention from a single severe childhood genetic disease (SCGD) to up to as many as 80 SCGD and testing of ~40 million newborns/year worldwide. However, the gap between current NBS and its potential to increase the efficiency, effectiveness and global equity of healthcare delivery for SCGD is large and rapidly growing. There are now effective therapeutic interventions—drugs, diets, devices and surgeries—for up to 2000 SCGD. Since almost all SCGD can be identified by bloodspot genome sequencing, it has been a longstanding goal to supplement current NBS with genome sequencing-based NBS (gNBS) for all eligible SCGD. We recently described a novel gNBS platform (named Begin Newborn Genome Sequencing (BeginNGS)) with the potential to overcome several major challenges to gNBS (cost, scalability, false positives and an unprepared healthcare workforce). A pilot clinical trial of BeginNGS for 412 SCGD in a level IV neonatal intensive care unit (NICU) had a true positive rate of 4.2%, sensitivity of 83%, positive predictive value of 100% and clinical utility rate of 4.2%, indicating readiness of the platform for use in a powered, multicentre study.

The BeginNGS study is a single group, international, multicentre, adaptive clinical trial to compare utility, acceptability, feasibility and cost-effectiveness of BeginNGS gNBS (experimental intervention) with standard NBS (control). A minimum of 10 000 neonates (aged 50 000 US children per year.

This study was approved by the WCG Clinical institutional review board on 14 February 2024, and the most recent amendment approved on 7 October 2025 (approval number 20235517). Study findings will be shared through research consortium workshops, national and international conferences, community presentations and peer-reviewed journals.

NCT06306521.

Heightened rates of mental illness among children, young people and forcibly displaced adults are well-documented. Despite this, access to care in host countries is often low. Problem-management plus (PM+) is an intervention developed by the WHO that can be delivered through task-shifting by lay counsellors and has been shown to be effective in numerous studies. At the same time, it has been shown that PM+ has a limited effect on traumatic stress symptoms, a common problem among forcibly displaced individuals. In turn, to further these benefits, a novel emotional processing (EP) module has been developed to be adjunctively delivered alongside PM+(PM+EP).

The current study is a randomised controlled feasibility and acceptability study. 60 participants aged 16–25 will be randomly allocated to either PM+, PM+EP or care as usual. The primary outcome of this study will be the feasibility and acceptability of the delivery of PM+EP in forcibly displaced youth. Secondary outcomes are self-rated measures of distress, depression and anxiety, post-traumatic stress disorder, personally identified problems, hope, use of services and medications, general well-being and social support.

Following ethical approval in February 2024, recruitment commenced in October 2024. Study completion is anticipated by December 2025. Findings will be disseminated via peer-reviewed publications, conference presentations and communication with relevant stakeholders.

NCT06878092.

Many patients who are extubated after receiving mechanical ventilation for acute respiratory failure experience extubation failure (ie, require reintubation hours to days after extubation). High-quality evidence shows that extubating patients directly to non-invasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC), rather than conventional low-flow oxygen, can prevent extubation failure. These guideline-recommended interventions, however, require care coordination involving multiple intensive care unit (ICU) team members and are infrequently used. Interprofessional education (IPE), which teaches members of multiple professions together, could effectively address this implementation gap in complex, team-based, critical care settings, particularly when paired with a customisable protocol.

This batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness–implementation trial will test three hypotheses: (1) when compared with traditional online education (OE), IPE increases implementation of preventive postextubation respiratory support, (2) the benefits of IPE are increased when paired with a clinical protocol and (3) preventive postextubation NIV for high-risk patients and preventive postextubation HFNC for low-risk patients reduce in-hospital mortality when compared with conventional postextubation oxygen therapy. The trial will recruit 24 clusters made up of one or more ICUs that care for at least 100 mechanically ventilated patients per year in a large multihospital health system in the USA. All clusters will receive OE, IPE and a clinical protocol, with timing determined by randomisation. We will also randomise half of the clusters to education promoting postextubation NIV for patients at high risk of extubation failure and preventive, postextubation HFNC for patients at lower risk, whereas the other half will be randomised to education promoting postextubation HFNC for all eligible patients. We will include all patients who are invasively mechanically ventilated for at least 24 hours. The primary implementation endpoint is the rate of use of postextubation NIV or HFNC among eligible participants. The primary clinical endpoint is in-hospital mortality truncated at 60 days from intubation.

This study was approved by the institutional review board of the University of Pittsburgh and an independent data safety monitoring board. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. We will disseminate results to participating healthcare providers, through publication in a peer-reviewed medical journal and via presentations at international conferences.

NCT05523479.

Despite advances in the physiotherapy management of low back pain (LBP) worldwide, studies indicate that there is a large variation in the quality of physiotherapy management for LBP in Nigeria. This clinical trial aims to evaluate the implementation of individualised physiotherapy for chronic LBP in Nigeria using the Specific Treatment Of Problems of the Spine (STOPS) approach.

This will be an implementation clinical trial using a non-randomised, prospective, sequential comparison design. One hundred and fifty-four participants with chronic LBP will be recruited at one hospital in Nigeria. In phase I, participants will receive 11 sessions of usual physiotherapy care. In phase II, consenting physiotherapists will undergo training in the implementation of the STOPS treatment approach, led by the original Australian developers. In phase III, participants will receive 11 sessions of individualised physiotherapy using the STOPS approach. Patient evaluation in phases I and III will be measured at baseline and at 5, 10, 26 and 52 weeks, and will evaluate the clinical outcomes (including primary outcomes of pain intensity measured with a 0–10 Numerical Rating Scale, and activity limitation measured via the Oswestry) and cost-effectiveness from the healthcare perspective (incremental healthcare costs relative to incremental quality adjusted life-years gained on the EuroQOL-5D-5L). Physiotherapist outcomes will include confidence in treating LBP and implementation behaviour measured at the start of phase I and at the end of phases I, II and III. Implementation feasibility and qualitative analysis of patient and physiotherapist experiences will also be explored.

The trial has been approved by the Human Research Ethics Committees of La Trobe University, Australia (HEC22278) and Federal Medical Centre (FMC) Nguru, Yobe State, Nigeria (FMC/N/CL.SERV/355/VOL IV/131). The study results will be shared through peer-reviewed journals and conferences.

PACTR202305707317550.

Several studies suggested that short-term variations in out-of-hospital cardiac arrest (OHCA) might be associated with the day of the week and holidays. However, most existing findings were based on Western countries, outdated data (the 1990s or 2000s) and analytical methods that could not control potential confounders.

Case time-series design.

The national OHCA surveillance (a population-level surveillance system operated by the Korea Disease Control and Prevention Agency) from 2015 to 2019.

A total of 89 164 cardiac-origin OHCA cases.

Not applicable.

Cardiac-origin OHCA incidents (primary) and fatality of the OHCA incidents (secondary).

We found that Mondays (relative risk (RR): 1.019 with 95% CI: 1.009 to 1.029) and Sunday (RR: 1.015 with 95% CI: 1.005 to 1.025) had the highest risk of OHCA incidence compared with other weekdays. Holidays showed a higher association with increased OHCA risks than non-holidays. Higher RRs were observed on Christmas (RR: 1.096 with 95% CI: 1.063 to 1.129) and Lunar New Year’s Day (RR: 1.082 with 95% CI: 1.060 to 1.104) compared with non-holidays. These patterns by the day of the week and holidays were heterogeneous by age, sex and urbanicity level.

This study provides epidemiological evidence of the association of the day of the week and holidays with OHCA incidents in South Korea, using national surveillance data and state-of-the-science statistical methods. Our findings could contribute to the implications for more targeted action plans and public health resource mobilisation against OHCA.

Childbirth can have psychological, social and emotional effects on women and their families. Psychological birth trauma (PBT) is defined as the emotional distress and mental health challenges resulting from negative or distressing experiences during the childbirth process. Labour management plays an important role in the health of women and children. Consequently, the study aims to assess the status of PBT among Iranian women, identify factors influencing it and suggest effective preventive strategies.

This study is a mixed-method research with an explanatory sequential approach. The first phase is quantitative and cross-sectional, involving 300 postpartum women visiting health centres in Tabriz-Iran. In this phase, cluster sampling will be used, and data will be collected using the following questionnaires: Sociodemographic and Obstetric Characteristics, Birth Trauma Scale, PTSD Symptom Scale 1, Perceived Quality of Care Scale, Childbirth Experience Questionnaire version 2.0, Edinburgh Postpartum Depression Scale, Postpartum Specific Anxiety Scale Research Short-Form and the questionnaire on the desire for subsequent pregnancy. The second phase is qualitative, and participants will be selected based on the results of the quantitative phase and extreme cases, using purposive sampling. Data analysis will be performed using qualitative content analysis with a conventional approach. Qualitative data will be collected through in-depth and semi-structured individual interviews with open-ended questions. In the third phase, strategies to prevent childbirth psychological trauma will be designed by integrating the results of the quantitative and qualitative studies, reviewing the literature and gathering expert opinions using a modified Delphi study. Examining PBT and its influencing factors can provide culturally relevant, evidence-based strategies. These strategies can be effective in improving the quality of care for women during childbirth.

This study has received approval from the Ethics Committee of Tabriz University of Medical Sciences in Tabriz, Iran (code number: IR.TBZMED.REC.1402.945). All participants will provide written informed consent before taking part in the study. The outcomes will be shared through articles published in journals, presentations at medical conferences, the validation of a reliable scale for assessing the level of PBT in postpartum women, and the provision of strategies to prevent childbirth psychological trauma. These resources will be valuable for policymakers and healthcare providers.