Forced migrants (i.e., asylum seekers and refugees) experience greater mental health disparities and inequities in care. Mental health services and systems lack clear policy on integrated mental healthcare. Understanding the causal mechanisms of integrated mental health for migrants can promote a resilient and adaptive health and social care system. However, to achieve a functional mental health service integration, there is a need to understand how and why mental health system integration works and under what health systems conditions. The purpose of this realist review protocol will be to outline a process for refining an initial programme theory (IPT), developed through deliberative dialogues with key interest groups in British Columbia, Canada, and to test the IPT against the global evidence base.

A realist review is an interpretive methodological approach to synthesising the literature based on the realist philosophy of science. Realist reviews are pragmatic approaches to theory development because they involve the participation of real-world actors or people who work within complex systems. Realist reviews are particularly useful for synthesising complex knowledge. We plan to conduct a seven-step review process, with iteration between each step. Steps 1–3 have already been completed in our previous work and included the development of an IPT, which will be refined systematically by exploring the global literature and consulting with an international advisory group. These will be used iteratively to identify, test and refine the programme theory. The quality of included literature will be appraised using the relevance, richness and rigour criteria and the realist quality appraisal tool, TAPUPASM (transparency, accessibility, propriety, utility, purposiveness, accuracy, specificity and modified objectivity). Steps 4–7 will include data extraction and realist analysis through retroductive theorising using the ICAMO (intervention, context, actor, mechanism and outcome) heuristic to help distinguish actors and resources from contexts, mechanisms and outcomes.

Ethics approval for the deliberative dialogue interviews that inform this realist review and IPT were obtained by the University of British Columbia (ref: REB Number: H22-03195). Study recruitment occurred between 21 November 2023 and 16 January 2024. All participants provided informed consent to take part in deliberative dialogues and to have their interviews audio recorded and transcribed for the purpose of this research. We will disseminate results of the review through academic papers, conference presentations and through iterative interest group workshops and discussions.

CRD42024580083.

Losses of functional reserve across multiple physiological systems have been identified in frail patients, yet the exact aetiology of frailty remains unclear. Although strongly associated with chronological age, frailty often develops at a younger age in patients with organ failure. Frailty is prevalent in patients with kidney failure; however, individuals experience improvements in physical frailty measures following kidney transplantation. This makes younger patients with kidney failure a unique population for studying both the accelerated onset of frailty and its reversal. This research project aims to test the hypothesis that frailty secondary to organ failure and age-related frailty are associated with similar molecular and physiological measures.

This longitudinal study will recruit 150 patients in three groups. Group A (kidney transplant recipients aged ≥40 years; n=50) and Group B (patients aged ≥40 years active on the kidney transplant waitlist; n=50) will comprise younger adults with frailty from organ failure. Group C (adults aged ≥65 years (or ≥55 years for Aboriginal and Torres Strait Islander patients); n=50) will comprise older community dwellers. The primary outcome is the Frailty Index (FI). Secondary outcomes include the change in FI over time, and at baseline when considering various clinical metadata, immune parameters, kidney function and nutrition intake which will be measured at baseline and 12-month time points. Longitudinal changes in frailty will be analysed using linear mixed models with multiple testing corrections for false discovery rates.

Endocrine profiles and metabolomics, measures of immune function and microcirculatory dysfunction, will be measured by liquid chromatography-mass spectrometry and/or gas chromatography-mass spectrometry. The gut microbiome will be sequenced via shotgun metagenomics (Illumina NextSeq500, 150 bp paired-end, ³Gbp/sample). Circulating cell-free DNA/mitochondrial DNA will be quantified through droplet digital PCR. Microcirculation will be assessed via sublingual dark field videomicroscopy with glycocalyx markers measured by ELISA.

This study will be conducted with all stipulations of this protocol, and the conditions of the ethics committee approval. Ethical principles have their origin in the Declaration of Helsinki, all Australian and local regulations and in the spirit of the standard of Good Clinical Practice (as defined by the International Conference on Harmonisation). Organs/tissues will be sourced ethically and will not be sourced from executed prisoners or prisoners of conscience or other vulnerable groups.

Ethics approval was received by the Metro South Health Research Ethics Committee (HREC/2023/QMS/95392) and ratified by the University of Queensland.

Results will be disseminated through peer-reviewed publications, academic conferences, participant newsletters and health organisation collaboration.

The roles of pharmacy staff have expanded to include public health functions, such as delivering harm reduction services for people who use drugs (PWUD), particularly unregulated substances and non-medical drug use, in response to an ongoing drug overdose crisis. Nonetheless, their involvement across the full spectrum of harm reduction services remains underexplored. This study mapped existing research describing or evaluating the implementation of harm reduction services for PWUD provided by pharmacy staff.

Scoping review.

MEDLINE, EMBASE, CINAHL, Web of Science, Scopus and Cochrane Library (inception to July 2025).

Studies reporting on the description or evaluation of harm reduction services for PWUD provided by pharmacy staff.

Two team members screened studies for eligibility and extracted the data. The data were analysed primarily to describe harm reduction services and the role of pharmacy staff.

43 articles were included. The most frequently reported harm reduction services were sexually transmitted and blood-borne infection care (33%), needle and syringe programmes (21%), naloxone distribution (19%) and medication treatment for opioid use disorder (19%). Pharmacy staff were integrated into multidisciplinary teams (79%), with their roles varying from education to medication prescribing. Included studies reported harm reduction services for PWUD delivered by pharmacy staff as effective, feasible and safe. However, implementations were not tailored to equity-deserving populations. Services primarily addressed opioid-related harms, while strategies focusing on the use of non-opioid substances were limited.

This scoping review highlights the diverse roles pharmacy staff play in delivering harm reduction services for PWUD. Positioned at the intersection of accessibility and healthcare delivery, pharmacy staff are ideally situated to expand access to equitable care. To fully harness this potential, future research and practice should embed harm reduction as a core philosophy, extending beyond individual interventions to support the creation of person-centred, non-judgmental and low-barrier services.

Sympathetic activation is the hallmark of cardiac disease, driving disease progression and triggering ventricular arrhythmia (VA). Despite optimal medical therapy, many patients experience recurrent VAs refractory to medical therapy, leading to repetitive implantable cardioverter defibrillator (ICD) therapy, worse quality of life and adverse outcomes. Cardiac sympathetic denervation (CSD) through surgical removal of the stellate ganglia is an effective treatment for refractory VAs but carries a high complication rate. We hypothesise that high precision image guided radiotherapy can be used to target the stellate ganglia to achieve CSD non-invasively.

RADIO-STAR (hypofractionated radiotherapy to the stellate ganglia for ventricular arrhythmia) is a first-in-human, phase 1 safety and dose finding study of radiotherapy to the stellate ganglia in patients with recurrent VAs. Patients with structural heart disease requiring recurrent ICD therapy for VAs are invited to undergo radiotherapy bilaterally to their stellate ganglia with a predetermined sample size of n=13. Radiotherapy dose will be determined by a prespecified dose escalation protocol. The primary outcome is safety defined as any treatment-related grade 3–5 toxicity occurring within 6 months of radiotherapy treatment, as defined by the Common Terminology Criteria for Adverse Events or any treatment-related side effects detected on patient symptom questionnaires and clinical examination during study visits. Secondary outcome measures to evaluate feasibility and efficacy include ability to safely deliver radiotherapy and consequent changes in circulating catecholamines and neuropeptide-Y, heart rate variability, structural changes in the stellate ganglia on MRI imaging and ICD therapy burden.

This study has received ethical approval by the South Central—Oxford B Research Ethics Committee (REC/SC/0005). Study findings will be submitted for publication in peer-reviewed scientific journals and presented at national and/or international scientific conferences.

ISRCTN49861434.

Sodium-glucose cotransporter (SGLT) inhibitors have shown substantial benefit in reducing cardiovascular and kidney events across diverse clinical populations, but the underlying physiological mechanisms remain unclear. However, existing mechanistic studies on renal and cardiovascular haemodynamics show variability in design, have limited statistical power and yield inconsistent outcomes, thus limiting the ability to draw generalisable conclusions. To address this gap, we conducted a systematic review and proposed the first meta-analysis to aggregate individual participant-level data from mechanistic studies to identify consistent physiological patterns and enhance understanding of the therapeutic effects of SGLT inhibition.

Gold-standard measured glomerular filtration rate (mGFR) was selected as the primary outcome for this systematic review, which aimed to identify all completed mechanistic studies investigating the effects of SGLT inhibition. Electronic databases including Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; and Cochrane Central Register of Controlled Trials were searched using a detailed search strategy. In total, 24 studies (n=1296) were identified. This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Key variables including demographics, medical history, concomitant medications, vital signs, mGFR, renal haemodynamics, urine and plasma biochemistry, tubular sodium handling, echocardiography, cardiac output monitoring, arterial stiffness and fluid volume will be extracted. A one-stage individual participant data meta-analysis under a Bayesian framework will be conducted, using hierarchical models to simultaneously analyse data from all eligible studies. The risk of bias due to missing results will be assessed. Sensitivity analyses and subgroup evaluations will be incorporated to explore sources of heterogeneity and assess robustness of findings.

Ethics approval was obtained from University Health Network, Toronto, Canada. Findings from the Mechanisms of SGLT Inhibitor Action and Physiological Mediators (MOSAIC) meta-analysis will be published in peer-reviewed journals and results will be disseminated at scientific conferences.

CRD420251001413.

India had an estimated three to five million excess deaths from causes attributable to SARS-CoV-2 during 2020–2021, far exceeding official government statistics. Most deaths in India occur in rural areas, where medical certification of deaths is limited. Yet, the effects of the pandemic in rural settings remain largely undocumented. We estimated the cause-specific excess mortality in rural areas of selected states of India.

Longitudinal analyses of hospital mortality data.

India’s Health Management Information System (HMIS) reports the number of deaths by cause for adolescents or adults aged 10 years or more. We examined eight states with high coverage of the expected number of deaths in rural areas.

We analysed monthly death reports from the HMIS, which covered approximately 0.2 million health facilities during 2018–2023. We compared excess deaths during the peak COVID-19 months in rural health facilities to pre-COVID-19 and non-peak periods of 2021, and categorised reported causes by their probable association with COVID-19.

Excesses of cause-specific and total mortality.

During the April–June 2021 SARS-CoV-2 wave, predominantly driven by the Delta variant, monthly deaths in rural health facilities across India surged from approximately 200 000 to 500 000. In eight states with high-quality reporting, rural facility deaths increased by 270% (95% CI 267% to 272%) compared with the same months in 2018–2019, prior to the COVID-19 pandemic. Notably, this surge occurred despite a sharp decline in hospital admissions following the national lockdown in March 2020. The largest relative increase was for fever-related and respiratory diseases, and these deaths were markedly elevated even when compared to non-peak months of 2021. Generalising these findings from eight states to all of rural India yields an estimate of approximately 2.6 million excess rural deaths in April–June 2021. In contrast, there were few excess deaths during the Omicron viral waves in 2022–2023.

COVID-19 substantially increased deaths in rural India during April–June 2021, but reassuringly, no significant excess mortality was observed in subsequent years. The HMIS provides an important opportunity to strengthen routine mortality surveillance in rural India.

Onchocerciasis, commonly known as river blindness, is a parasitic disease caused by Onchocerca volvulus affecting millions predominantly in sub-Saharan Africa. Robust epidemiological evidence points to a clinical relationship between onchocerciasis and epilepsy, a condition termed onchocerciasis-associated epilepsy (OAE). Despite extensive research and various successful elimination programmes over the past decades, the pathogenesis of OAE is still unknown. Current hypotheses propose that O. volvulus microfilaria, their excretory-secretory products or the newly discovered filarial O. volvulus RNA virus 1 (OVRV1) virus may traverse the blood-brain barrier, triggering seizures or immune responses that result in neurological damage. However, direct evidence of microfilaria or their DNA in cerebrospinal fluid (CSF) or brain tissue remains elusive, likely due to immune-mediated parasite clearance. Additionally, investigations into the potential neurotoxicity of these novel filarial viruses have yet to be pioneered.

This prospective cohort study will involve 100 ivermectin-naïve children aged 2–5 years, recruited from rural communities in the Aketi health zone, located in the Democratic Republic of Congo. This region is known to be an onchocerciasis-endemic area with a high prevalence and transmission of OAE, despite years of community-directed treatment with ivermectin. Lumbar punctures (LP) will be performed in children presenting with complex febrile seizures according to WHO’s paediatric guidelines. CSF samples will be examined for white blood cells, protein levels, glycorrhachia, microfilaria, OVRV1 and O. volvulus biomarkers. Children will be followed annually, monitoring the development of epilepsy and O. volvulus infection. This approach aims to elucidate the presence of O. volvulus and OVRV1 in the brain and their role in the pathogenesis of epileptic seizures and the myriad of clinical symptoms observed in OAE.

The protocol has been approved by the Ethics Committee of the University of Kisangani (UNIKIS/CE/KGB/001/2025) and the University of Antwerp (project ID 7323-Edge n/a-BUN B3002025000078). Written informed consent will be obtained from all parents and/or legal guardians of children for whom an LP is considered. Findings will be disseminated at national and international levels via meetings and peer-reviewed open-source publications. Study data will be stored in an open repository.

Pan African Clinical Trials Registry (PACTR202507670131109).

The current German treatment guideline for chronic ischaemic heart disease (IHD) recommends that general practitioners (GPs) deliver brief advice on physical activity (PA) to patients with IHD. Such advice consists of at least three elements (ie, 3As): (1) assessing the PA level, (2) advising on PA and (3) assisting with recommendations. This study examined the extent to which individuals with self-reported IHD in Germany reported the receipt of such advice.

Cross-sectional population-based face-to-face survey (from June 2023 to August 2024).

Households across Germany.

1004 individuals aged 35+ years with self-reported IHD and GP contact.

Primary outcome: self-reported proportions of receipt of GP-delivered PA advice according to the 3As. Main secondary outcome: associations between person characteristics and the likelihood of receiving PA advice.

Among individuals with self-reported IHD, 36.4% (95% CI 33.4% to 39.4%) received all 3As of PA advice, 42.1% (95% CI 39.1% to 45.2%) received one or two elements, 9.9% (95% CI 8.1% to 11.8%) received no advice at all and 3.8% (95% CI 2.7% to 5.1%) were advised to avoid PA (7.9% did not remember/refused to answer). Women (vs men) were more likely to receive no advice (OR=1.74, 95% CI 1.11% to 2.72%), while middle (vs younger) aged individuals (OR=0.46, 95% CI 0.22% to 0.99%), those with PA levels of 1–149 min/week (vs no PA; OR=0.16, 95% CI 0.08% to 0.31%) and of 150+ min/week (vs no PA; OR=0.13, 95% CI 0.07% to 0.23%) and those with higher (vs lower) education (OR=0.39, 95% CI 0.20% to 0.76%) were less likely to receive no advice. Individuals living in urban (vs rural) areas (OR=0.65, 95% CI 0.46% to 0.88%) and those with PA levels of 1–149 min/week (vs no PA; OR=0.59, 95% CI 0.37% to 0.95%) and of 150+ min/week (vs no PA; OR=0.55, 95% CI 0.36% to 0.84%) were less likely to receive only one or two (vs all) of the 3As. Of those who received at least one element of advice (n=788), 72.5% reported they were more active afterwards, with a higher proportion when all 3As (vs only some elements) were provided (86.8% vs 59.6%).

Only one-third of individuals with self-reported IHD in Germany received comprehensive PA advice. Specific person characteristics, such as female gender and lower education, were associated with lower proportions of received PA advice. Efforts are needed to improve GP-led PA guidance, particularly for underserved groups.

German Clinical Trials Register (DRKS00031304).

Rising patient numbers and limited resources are creating a challenging environment for healthcare providers recently. Anaesthesiologists are also increasingly faced with complex situations, requiring high adaptability in the operating room. To enhance team adaptability during emergencies, effective communication methods are essential. This study aimed to compare the impact of mobile phones and intercoms on the response time and effectiveness of anaesthesiologist teams in emergency situations.

Prospective, observational and simulation study.

Anaesthesiology and Critical Care, Yokohama City University Medical Center, Yokohama, Japan.

This study, conducted at Yokohama City University Medical Center (Yokohama, Japan), evaluated how communication methods (intercoms vs mobile phones) impact the efficiency of anaesthesiologists in the simulation setting. Two scenarios were tested: (1) retrieving a video laryngoscope during a difficult intubation and (2) gathering support during cardiac arrest.

Outcomes measured included time to secure equipment, time for assistance to arrive and staff numbers gathered. The Wilcoxon signed-rank test was used to compare the outcomes between the intercom and mobile phone groups.

In scenario 1, the time to secure the video laryngoscope was significantly shorter with intercom use compared with mobile phones (intercom vs mobile phone, median (IQR): 29 (25–33) s vs 50 (39–62) s; p=0.013, effect size 20 (95% CI 7 to 31)). In scenario 2, the time from the request for assistance until the first supporting staff member reached the operating room was significantly shorter in using the intercoms (intercom vs mobile phone, median (IQR): 16 (14–18) s vs 35 (31–38) s; p=0.04, effect size 17 (95% CI 6 to 24)), and more personnel were available in the intercom group (intercom vs mobile phone, median (IQR): 3 (3–3.5) persons vs 2 (1–2) persons; p=0.04, effect size 1.5 (95% CI 1 to 3)).

Real-time information sharing through intercoms improved the ability of the anaesthesiologist team to respond more rapidly and effectively in emergency situations, enhancing overall team adaptability. This approach may improve patients’ outcomes by shortening response times and increasing team coordination.

The second phase of the Chiba Study of Mother and Child Health (C-MACH) was initiated to investigate how environmental exposures from the fetal period to early childhood influence maternal and child health outcomes. The sub-cohort focuses specifically on detailed assessments of indoor environmental factors and neighbourhood-built and social environments. By integrating environmental metrics with biological, behavioural and sociodemographic data, the study aims to elucidate their role in the development of allergies, neurodevelopmental disorders and other non-communicable diseases in early life.

Between June 2021 and April 2023, 505 pregnant women were enrolled in the second phase of the C-MACH main study. Of these, 298 participants consented to join the sub-cohort study, including 258 in the sleep and physical activity monitoring option (Option 1) and 148 in the indoor allergen exposure sub-study (Option 2). The study includes biological sampling, environmental monitoring and repeated questionnaire surveys. At baseline, 253 live births were recorded from 251 pregnancies.

Of the 298 women, 272 completed early pregnancy questionnaires. The mean maternal age was 33.1 years (SD 4.6); 97.8% were married. University-level education was reported by 51.0% of mothers and 53.7% of fathers. Most households had an annual income of 6 to

Longitudinal follow-up will continue until the children reach age 15. Future analyses will examine associations between environmental exposures and allergic, developmental, endocrine/metabolic and obesity-related outcomes.

Since 1985, the international healthcare community has recommended the ideal rate of caesarean section (CS) to be 10%–15% at the national level. The literature has reported that overused CS without necessary medical indications can be harmful to both maternal and child health. To generate evidence to support policy on CS, this study evaluated the trend over time of CS in Thailand during January 2016 to October 2021 (which included the COVID-19 pandemic period) and explored predictors of CS use.

This study was a retrospective secondary data analysis of de-identified hospitalisation data under the Universal Coverage Scheme (UCS) from the National Health Security Office’s e-Claims database. Descriptive analyses were conducted to explore the number and rate of CS over time and across different characteristics (ie, age, hospital type, COVID-19 status and delivery day) including a multivariable logistic analysis to explore predictors of CS. Interrupted time series analysis was adopted to investigate the effect of the COVID-19 pandemic on CS rate.

569 321 CS cases under UCS from 2016 to 2021.

The results showed an increasing trend of CS rate, from 30% in January 2016 to 35% in October 2021. Both clinical (eg, medical indication and age) and non-clinical (eg, region and day of delivery) factors were significantly associated with CS. Furthermore, the COVID-19 pandemic had no significant effect on CS rate (level: –0.0016, 95% CI –0.0085 to 0.0053, p=0.66).

This study highlighted an increasing trend of CS in Thailand and could present supportive evidence that Thailand might have been facing an overuse of CS. More awareness and actions are warranted to ensure the movement towards reduction of unnecessary CS in Thailand.

Non-communicable diseases are the leading causes of premature mortality worldwide. Both genetic predispositions and environmental exposures affect disease risk. While biobanks have increased understanding of genetic predictors of these diseases, environmental influences are expected to have a greater impact on disease development. Individuals also create their own environments and lifestyles based on genetically regulated preferences, leading to gene–environment interactions that require large datasets to study. Finnish biobanks typically lack sufficient lifestyle and environmental data, which limits their use. We present a protocol for a biobank-recall study (BioRecall) to collect data on lifestyle and environmental exposures and combine these findings with genotypes, biological samples and clinical outcomes.

All previously genotyped donors from the Central Finland Biobank who have been diagnosed with type 2 diabetes and have consented to recall will be invited to participate in the pilot study. The preliminary feasibility assessment reveals that there are 1580 suitable candidates. Participants will complete an electronic questionnaire on a secure online platform. The questionnaire includes validated questions on lifestyles, anthropometrics, weight loss history, health, symptoms, work characteristics, emotional states and residential environments. Postcode information will facilitate the addition of spatial environmental data. Genotype and related clinical data will be provided in the study in accordance with the Finnish Biobank Act and combined with questionnaire data.

The Human Sciences Ethics Committee of the University of Jyväskylä delivered a favourable statement regarding the study protocol (1671/13.00.04.00/2023). Central Finland Biobank approved the research plan (no: BB24-0333-A01). The data collected will be returned to the Central Finland Biobank for research purposes with the participants’ consent. Permission for data usage can then be applied through standard protocols of the Fingenious service (https://site.fingenious.fi/en/). If successful, the study will be expanded to other donors and Finnish biobanks.

This study aimed to investigate the effects of long-term and habitual physical activity on mortality and long-term care insurance (LTCI) certification among cancer survivors using a population database.

5-year retrospective study.

13 Japanese municipalities participated in the Longevity Improvement & Fair Evidence study.

Among 471 511 participants who underwent health check-ups, 39 435 met the following eligible criteria: documented in the cancer claims database without a suspected diagnosis and participated in a health check-up at least once in a 12-month period, had no missing exercise data and had already been certified for LTCI.

Outcomes were new LTCI certification and all-cause mortality. LTCI certification was assigned by a trained local government official through a systematic process (involving various items—physical function, daily activity function, cognitive function, behavioural disorders, adjustment to social life and daily use of medical services—as well as overall consideration of computer-based and specialist team assessments), and the LTCI severity level correlates with the Barthel index. LTCI certification reflects some impairment in activities of daily living. All-cause mortality was defined based on claims data.

Three physical activity categories, ‘exercise and walking’, ‘exercise or walking’ and ‘no physical activity’, were used. Among survivors aged 65–74 years, the ‘no physical activity’ group had a higher risk of mortality and LTCI certification than the ‘exercise and walking’ group (adjusted model HR: 1.72, 95% CI 1.52 to 1.94). Among survivors aged ≥75 years, the low physical activity groups had a higher risk of mortality and LTCI certification than the ‘exercise and walking’ group (adjusted model: ‘exercise or walking’, HR: 1.51, 95% CI 1.29 to 1.85; ‘no physical activity’, HR: 1.66, 95% CI 1.43 to 1.92). The effects of physical activity differed according to cancer type.

Habitual physical activity had positive effects on cancer survivors. These effects differed according to age and cancer type.

Oxaliplatin, a key drug in the treatment of colorectal cancer (CRC), can cause oxaliplatin-induced peripheral neuropathy (OIPN) in a dose-dependent manner. These symptoms can severely affect daily life, and chronic OIPN often limits treatment continuation because of its correlation with the cumulative dose of oxaliplatin. Currently, effective preventive measures are unavailable. However, surgical glove compression therapy may reduce paclitaxel-induced neuropathy, suggesting its potential in preventing OIPN.

This multicentre, randomised, open-label, phase II/III trial evaluates surgical glove compression therapy to investigate the possible preventive effects of OIPN in patients with CRC receiving adjuvant capecitabine plus oxaliplatin chemotherapy. Patients with stage III CRC undergoing curative surgery will be enrolled and randomised into two groups. The intervention group will wear two layers of tight-fitting surgical gloves from 30 min before to 30 min after oxaliplatin infusion, whereas the control group will receive standard care. The primary endpoint is the incidence of grade ≥2 chemotherapy-induced peripheral neuropathy (CIPN) based on the Common Terminology Criteria for Adverse Events criteria. Secondary endpoints include quality of life assessments (Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item), duration and extent of OIPN as assessed using the Debiopharm Neurologic and Sensory Toxicity Criteria, chemotherapy completion rates, and adverse events. To detect a significant reduction in the incidence of CIPN, 170 patients will be enrolled (36% in the control group vs 15% in the intervention group). The planned case enrolment period is from 1 November 2024 to 31 October 2026.

This trial was approved by the Institutional Review Board of Hiroshima University, Japan (approval no. CRB2024-0008), and has been registered with the Japan Registry of Clinical Trials (jRCTs062240066). The results of this study will be submitted for publication in a peer-reviewed journal and shared with the scientific community at international conferences.

jRCTs062240066

Colorectal cancer (CRC) is the fourth most common cancer in the UK and second leading cause of cancer-related deaths. The faecal immunochemical test (FIT) is a non-invasive home-based test used for both symptomatic assessment and population-based screening. However, approximately 30% of screening FIT kits and 10% of symptomatic FIT kits are never returned. Under-served populations, including ethnic minorities, socioeconomically deprived communities and those with mental health conditions, experience particularly low FIT return rates, contributing to health inequalities in CRC outcomes. This systematic review aims to synthesise evidence on the effectiveness and acceptability of interventions to improve FIT returns in both asymptomatic screening and symptomatic populations, with particular focus on under-served communities.

We will conduct a systematic review of qualitative and quantitative evidence. We will search Scopus, MedLine via Ovid, CINAHL via Ebsco and Cochrane Central Register of Controlled Trials from September 2010 onwards, supplemented by reference screening and trial registry searches. Eligible studies will include randomised controlled trials, quasi-experimental studies, observational studies, qualitative studies, mixed-methods studies and implementation studies examining FIT interventions in screening or symptomatic populations. Two reviewers will independently screen search results for eligible studies. Data extraction will capture study characteristics, population demographics, intervention components and outcomes including FIT return rates, acceptability, feasibility and implementation factors. Quantitative data will undergo systematic tabulation and meta-analysis where appropriate, with narrative synthesis for heterogeneous studies. Qualitative data will be analysed using framework-based thematic analysis, mapping findings to both the theoretical domains framework and theoretical framework of acceptability. A mixed-methods synthesis will integrate quantitative and qualitative findings to identify intervention characteristics, implementation strategies and contextual factors associated with improved outcomes across different population groups.

Ethics approval is not required as this systematic review will analyse published studies. Findings will be disseminated through peer-reviewed publication and conference presentations.

CRD420251111663.