First-degree relatives of colorectal cancer (CRC) patients have a twofold to fourfold increased risk of CRC. Tailored communication interventions have shown efficacy in improving their risk awareness and screening participation. While computer-based tailoring systems offer convenience, they often overlook the integration of healthcare professionals’ verbal input, potentially limiting effectiveness and long-term impact. To address this gap, we developed ScreenTalk, an intelligent voice-interactive tailored communication system that employs intelligent speech interaction to automate the tailoring process, enhance message credibility and improve scalability within CRC screening workflows.

This study is a two-arm, cluster-randomised controlled trial with a hybrid type I design involving 314 participants across three tertiary general hospitals in Guangzhou, China. Participants in both groups will receive usual care. Additionally, the intervention group will receive a 1-month tailored intelligent voice-interactive intervention, whereas the control group will receive unrelated health education to control for attention. Screening uptake (primary outcomes) and health beliefs (secondary outcomes) are measured at baseline and at 3 months, 6 months, 9 months and 12 month post the intervention. Implementation outcomes including reach, implementation, adoption and maintenance will be assessed through questionnaire, qualitative interviews and tailored system record.

The trial has been approved by the Ethics Committee of the Sun Yat-sen University (IRB No. L2024SYSU-HL-054). Information on the purpose and process of this study will be provided to the participants before recruitment, and written signatures will be collected from all participants to ensure their voluntary participation and protection of their rights and privacy.

NCT06710860 on ClinicalTrials.gov. Registered 26 November 2024. Date and version: 3.0, 14 July 2025.

To develop an updated core dataset for acute stroke care in Ireland, informed by international audit benchmarking and national stakeholder consensus, for integration into the Irish National Audit of Stroke (INAS).

Scoping review and three-round Delphi process.

Medline Ovid, Embase, CINAHL EBSCOhost, Google Scholar, audit websites and grey literature (2010–2024). Additional audit documentation was obtained via direct author contact.

National stroke audits or registries with a country-wide scope, ≥1 year of continuous data collection and active in 2021 were eligible. Only audits covering acute stroke care were included in this study phase. All records were screened for inclusion.

Audit documentation (data dictionaries, item definitions and contextual metadata) was retrieved from eligible audits. Acute stroke care items were extracted, charted and benchmarked against existing INAS items and each other to identify commonalities and gaps. Frequently collected international items (appearing in ≥4 audits/registries) were shortlisted. A three-round Delphi process with 24 national stakeholders (clinicians, nurses, allied health professionals, researchers, policymakers and patient representatives) was conducted to audit and refine the dataset through structured, anonymised item rating, iterative feedback and consensus-building discussions.

Twenty-one eligible international stroke audits/registries were identified, yielding ~4500 audit items. Benchmarking against existing INAS items (n=103), frequently collected international items (n=97) and expert-suggested items (n=22) informed the Delphi consultation. The final dataset expanded INAS by 18 items, totalling 86 acute care and 35 thrombectomy-specific items. New additions included stroke-related complications and risk factor documentation.

This structured, consensus-led process resulted in an internationally benchmarked, stakeholder-informed core dataset to enhance standardised stroke auditing in Ireland. The expanded dataset supports enhanced clinical monitoring, quality improvement and health system planning. This approach may inform audit development and research efforts in other contexts.

EmbryoGlue, a commercially available hyaluronic acid (HA)-enhanced culture medium, is commonly recommended as an adjunct to support embryo implantation. Given the current lack of conclusive evidence regarding its efficacy and safety, this study aims to evaluate the effectiveness and safety of HA-enriched medium in women undergoing in vitro fertilisation (IVF) treatment.

This multicentre, patient-blinded, randomised controlled trial involves couples planning a single fresh or frozen blastocyst-stage embryo transfer. On the morning of embryo transfer, individual blastocysts are randomly allocated to either a high-concentration HA medium (EmbryoGlue, 0.5 mg/mL) or a conventional low-concentration HA medium (G-2 PLUS, 0.125 mg/mL). The primary outcome is live birth rate per embryo transfer, with secondary outcomes including biochemical pregnancy rate, clinical pregnancy rate, miscarriage rate, ectopic pregnancy rate, ongoing pregnancy rate, multiple pregnancy rate, as well as obstetric and perinatal outcomes and related complications. The trial plans to enrol 858 female patients from four IVF centres in China, with 429 patients in each group.

The study has been approved by the Ethics Committee of Northwest Women’s and Children’s Hospital (approval no.: 2024–127), and all participating centres have obtained approvals from their respective institutional review boards or ethics committees. Results will be disseminated through publication in a peer-reviewed open-access journal and oral presentations at relevant domestic and international academic conferences.

NCT06492785.

Chronic pelvic pain, defined as persistent pain in the structures of the pelvis, is a condition that significantly impacts the health-related quality of life (HRQoL) of up to one-third of people worldwide, with substantial associated costs to both the individual and healthcare system/s. The present trial aims to establish the efficacy of e-hypnotherapy over relaxation and waitlist controls on pain, HRQoL and biopsychosocial outcomes, and evaluate cost-effectiveness.

A parallel-group, investigator-blinded, randomised controlled trial will be conducted. Eligible participants will be randomly allocated to either a 7-week online personalised e-hypnotherapy programme (n=44), a 7-week online personalised relaxation control (n=44) or waitlist control (n=44). The primary outcome will be self-reported pain level, and secondary outcomes will include psychological distress, QoL, pain catastrophising, self-efficacy, central sensitisation, somatic symptoms, fatigue and sleep. Cost-effectiveness will also be examined. Longitudinal qualitative interviews will be conducted with participants in the e-hypnotherapy (n=20) and relaxation (n=20) groups to understand meaningful change and barriers/facilitators for ongoing use.

This protocol has received ethics approval in Australia from the Deakin University Research Ethics Committee (DUREC ref. 2024-080). Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences related to chronic pelvic pain and mind–body interventions.

Australian New Zealand Clinical Trials Registry ACTRN12623000368639p.

TransformUs is a multicomponent school-based programme that offers teachers professional learning and resources aligned with the Australian curriculum to promote physically active teaching and learning, a supportive environment and physical activity opportunities during recess and lunch. The programme was originally developed for students in mainstream primary schools and has been proven efficacious for increasing physical activity and reducing sedentary behaviour in children without disability. The programme has been adapted for delivery with students with disabilities in primary and secondary schools (TransformUs All Abilities). This project aims to determine the implementation at scale and effectiveness of the TransformUs All Abilities programme to increase physical activity among primary and secondary school children and adolescents with disability. This protocol describes the hybrid implementation-effectiveness trial that will be used for this evaluation.

This study employs a hybrid type II implementation-effectiveness trial to evaluate the TransformUs All Abilities programme, targeting all government and independent, primary and secondary schools in Victoria, as well as special and mainstream secondary schools in Queensland and South Australia (n=2173 eligible schools). The effectiveness trial will focus on a subgroup of government/independent special schools for students with mild to moderate intellectual disability in Victoria, involving up to three intervention and three waitlist control schools (n=61 eligible schools). In both trials, outcomes will be guided by the RE-AIM framework focusing on reach, adoption and implementation (implementation trial) and effectiveness (effectiveness trial), with data collected at baseline and 6 months. The effectiveness trial will focus on students’ device-measured physical activity and sedentary behaviour—primary outcomes—and sleep, physical literacy and cognitive functions—secondary outcomes. Teacher feedback on the programme’s adaptation and their experience with programme implementation will also be collected, alongside qualitative feedback from a subsample of students regarding engagement/enjoyment and suggestions for improvements. Implementation data will be analysed descriptively and using linear mixed models to test changes over time. Effectiveness outcomes will be analysed using linear mixed models to compare intervention and waitlist control, accounting for confounding and school/classroom clustering. Interview data will be thematically analysed.

Ethical approval for this trial was obtained from the Deakin University Human Research Ethics Committee (2021-368). Clearance to conduct research in schools was also obtained from the Education Departments of Victoria (2023-004726), Queensland (550/27/2592) and South Australia (2022-0020). Informed consent is required for participation in the study. School staff can enrol in the implementation trial via the TransformUs website, while the effectiveness trial requires organisational, staff, parental/carer consent and student assent. Results will be disseminated through academic publications, scientific conference presentations and summary reports to schools, parents and partner organisations.

ACTRN12622001082796; Universal Trial Number: U1111-1281-1103; ACTRN12622001050741: U1111-1280-8828.

Sudden sensorineural hearing loss (SSNHL) is an otologic emergency that can profoundly impact patients’ auditory function and quality of life. While conventional treatments like corticosteroids offer moderate efficacy, a proportion of patients experience persistent deficits, highlighting the need for effective adjunctive therapies. Acupuncture has demonstrated therapeutic potential for SSNHL, but the relative efficacy of various acupuncture-related modalities remains unclear. This protocol outlines a systematic review (SR) and network meta-analysis (NMA) aimed at comprehensively evaluating the comparative efficacy of different acupuncture modalities in treating SSNHL.

An extensive literature search across nine databases and five clinical trial registries will be conducted to identify randomised controlled trials investigating acupuncture-related therapies for SSNHL. The primary outcome measure is the change in pure-tone audiometric thresholds. Secondary outcomes include the proportion of recovered patients, tinnitus severity, psychological symptoms and adverse events. Two independent reviewers will perform study selection, data extraction and methodological quality assessment using the Cochrane’s risk of bias (V.2.0) tool. A Bayesian NMA will be employed to compare the relative efficacy among multiple acupuncture modalities. The overall quality of evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation methodology.

As this study will use data from previously published studies, it does not require ethical approval. The findings of this SR and NMA will be disseminated through publication in a peer-reviewed academic journal.

CRD42024525763.

The internet of things (IoT) is widely used in nursing care for older adults as it improves the efficiency and quality of care, especially in real-time health monitoring, disease management and remote patient supervision. However, no studies have been identified that map the evaluation methods used in existing IoT technology applications for nursing care interventions. This scoping review will map and categorise the evaluation methods used in nursing care interventions examining the IoT for older adults.

This scoping review will be conducted using the Joanna Briggs Institute framework, which encompasses defining inclusion criteria, developing a search strategy, identifying information sources, selecting source of evidence, extracting data, collating data, summarising findings and presenting results. English, Chinese and Japanese databases will be searched (PubMed, Embase, CINAHL, PsycInfo, Cochrane Library, WanFang Data, VIP, SinoMed, China National Knowledge Infrastructure, Ichu-shi Web and CiNii research) for sources published from 1 January 2015 to 31 December 2024. The results will be reported descriptively and thematically according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines for reporting. Descriptive statistics and narrative analysis methods will be conducted to summarise the relevant topics.

Ethics approval is not required for this scoping review, as it encompasses a secondary analysis of previously published literature and does not involve the collection of primary data pertaining to human subjects. The findings of this review will be published in a peer-reviewed journal.

Breast cancer is common and women requiring mastectomy will be offered a breast reconstruction if they are surgically suitable candidate. Breast reconstruction can be performed at the same time as the mastectomy (immediate) or delayed to a second operation after cancer treatments. The reconstruction can either use the patients’ own tissue to make the breast (autologous) or use a prosthesis to make the breast in the form of a fixed or expandable volume implant (implant-based breast reconstruction, IBBR). Immediate breast reconstruction on top of the chest wall muscles (prepectoral) is performed worldwide. This operation involves the use of a synthetic or biological mesh placed around the implant under the skin. Increasingly, surgeons are performing this technique without the use of mesh. Both techniques, with and without mesh, have not been compared in a head-to-head randomised controlled trial (RCT); therefore, surgeons and patients do not have high quality data to guide their decision making in this area.

UK-based pragmatic multicentre randomised controlled feasibility trial. The primary aim is to determine the feasibility of a definitive RCT comparing the clinical and cost-effectiveness of no-mesh versus mesh-assisted prepectoral breast reconstruction. Secondary objectives will explore patient understanding of mesh and willingness to be randomised within an RCT; determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction and determine the feasibility of measuring breast biomechanics pre-surgery and post breast reconstruction surgery. Total number of patients to be included: 40 (20 per arm).

This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained. Ethics Ref: 23/SC/0302; IRAS Project ID: 301 423. The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs.

NCT06112977; ISRCTN17470747.

Both transversus abdominis plane block (TAPB) and transversalis fascia plane block (TFPB) have been shown to provide effective analgesia for caesarean section (CS) pain. However, the targeting of distinct spinal nerve branches by each technique suggests that neither approach offers complete analgesia. Moreover, the targeting of these branches by TAPB is influenced by puncture level, which has seldom been clearly defined in previous studies. This study aims to evaluate the efficacy of lower-level TAPB (L-TAPB), performed at the midpoint between the umbilicus and the anterior superior iliac spine along the anterior axillary line, by comparing it with those of classic umbilical-level TAPB (U-TAPB) and TFPB for postoperative analgesia following lower-uterine-segment (LUS) CS.

This single-centre, observer-blinded, randomised controlled trial will include 99 full-term parturients scheduled for elective LUS CS with a transverse incision under morphine-free spinal anaesthesia administered via a ‘needle-through-needle’ technique. Participant recruitment commenced on 3 March 2025 at the Second Affiliated Hospital of Wenzhou Medical University (WMU; Wenzhou, China). The anticipated trial completion date is October 2025. Participants will be randomised at a 1:1:1 ratio to receive L-TAPB, U-TAPB or TFPB postoperatively. Intrathecal morphine will not be used in this trial. The primary outcome of this trial will be hydromorphone consumption within the first 8 hours post-block. Secondary outcomes will include analgesic effectiveness and recovery indices such as pain scores over time, opioid consumption over time, the 15-item Quality of Recovery scale, overall satisfaction and other relevant measures. We will also assess adverse events.

All study procedures will adhere to Good Clinical Practice guidelines, with ethical approval obtained from the Ethics Committee of the Second Affiliated Hospital of WMU (approval no. 2024-K-322-02). The research findings will be published in peer-reviewed scientific journals.

ChiCTR2500097026.

This scoping review synthesises the application of patient journey mapping (PJM) in breast cancer care to provide insights for enhancing patient-centred services and improving the quality of life for patients with breast cancer.

Scoping review.

Web of Science, PubMed, Cochrane Library, CINAHL, Embase, CNKI, Wanfang and SinoMed were systematically searched for relevant studies published between 1 May 2005 and 1 May 2024.

Studies involving adults (≥18 years) with breast cancer that examined patient journeys were eligible, regardless of whether a formal PJM approach was used. All study designs in healthcare or community settings were considered. Exclusions included studies on other cancers, duplicates, inaccessible full texts, non-English/Chinese publications and non-original articles.

Two reviewers independently screened and extracted data, with a third resolving discrepancies. Information on study characteristics, methods and PJM applications was narratively synthesised and tabulated.

A total of 20 studies published from 2011 to 2024 were included. Four primary approaches to PJM in breast cancer care were identified, with cancer care stage mapping being the most prevalent. PJM illustrated patients’ trajectories, experiences and emotions, revealed critical interaction points such as diagnosis, decision-making and follow-up, and highlighted delays, coordination gaps and opportunities for service improvement. Most studies incorporated four core elements—patients, touchpoints, timelines and experiences—and emphasised patient perspectives across the care continuum, despite methodological heterogeneity.

This review shows that PJM has been applied to illustrate longitudinal healthcare experiences, identifies key touchpoints and supports the design and improvement of breast cancer care services. Most studies underscored patient perspectives and emotional needs, but current PJM applications remain fragmented, hospital-focused and weakly integrated across care settings and families. Future research should refine methodologies and apply digital technologies to develop personalised, dynamic maps that may enhance patient-centred care.