Poststroke depression (PSD) affects approximately 33% of stroke survivors and is associated with worse outcomes, poor quality of life (QOL) and mortality. Despite its prevalence and consequences, there is no consensus on the most effective strategy for PSD prevention. Behavioural activation (BA) is an effective intervention for depression across diverse populations and is considered safer, better tolerated and a longer-lasting alternative to antidepressant medications. This study aims to test the effectiveness of a remotely delivered BA intervention to prevent PSD (Tele-BA-S).

We will conduct a randomised effectiveness trial of 350 low-income adults (≥ 55 years) within 3 months of ischaemic or haemorrhagic stroke and with subthreshold depression (Patient Health Questionnaire-9 score

Ethical approval was obtained by the University of Texas Health Science Center at Houston’s (UTHealth Houston) Committee for the Protection of Human Subjects Institutional Review Board. The trial protocol, statistical analysis plan and code, and deidentified participant data will be made available via the National Institute of Mental Health Data Archive. The results will be presented at academic conferences and submitted for publication. The authors declare that they have no conflicts of interest relevant to the content of this manuscript.

NCT06864715.

‘Spin’ refers to reporting practices that distort the interpretation of results and mislead readers’ impression of the research findings so that the results are viewed in a more favourable light. This systematic review aims to assess the impact of spin on the impressions and/or interpretation of research findings among healthcare professionals and decision makers involved in health-related decision-making and to evaluate interventions/strategies designed to reduce the influence of spin.

This systematic review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE (via Ovid), EMBASE, the Cochrane Library (CENTRAL) and the Education Resources Information Center (ERIC) will be searched from their inceptions to 27 January 2026. Randomised controlled trials evaluating the impact of spin on participants’ impressions and/or interpretation of research findings, as well as trials assessing the effect of interventions/strategies on the recognition and interpretation of spin, will be considered. Study selection, data extraction and risk of bias (RoB) assessment with the Cochrane RoB2 tool will be performed independently by multiple reviewers. Where sufficient data are available, meta-analyses will be conducted.

As this study is based on a review of publicly available literature, ethical approval is not required. The findings will be disseminated through publication in peer-reviewed journals, presentations at international conferences and press releases.

INPLASY202620006.

Mycoplasma pneumoniae (MP) is a major cause of community-acquired pneumonia in children. In East Asia, the prevalence of macrolide-resistant MP (MRMP) has surged, leading to treatment failures and prolonged illness. While doxycycline is an effective alternative, its use in young children has historically been limited due to concerns about tooth discolouration. This study aims to evaluate the efficacy and safety of doxycycline compared with azithromycin as a first-line treatment for children with pneumonia suspected of MRMP infection.

This is a multicentre, randomised, open-label, parallel-group superiority trial conducted at 14 tertiary hospitals in South Korea. A total of 208 children (aged 3–17 years) with pneumonia and confirmed or suspected MP infection will be randomised 1:1 to receive either doxycycline (4 mg/kg/day in two divided doses for 7–14 days) or azithromycin (10 mg/kg on day 1, then 5 mg/kg on days 2–5) (). Randomisation will be stratified by age (3–7 years vs 8–17 years). A standardised ‘rescue therapy’ protocol ensures patient safety by allowing control group patients to switch to doxycycline if no clinical improvement is observed within 48–72 hours. The primary outcome is the defervescence rate within 72 hours after randomisation. Secondary outcomes include treatment failure rate, length of hospital stay, symptom duration and adverse events. Safety assessment will specifically include tooth discolouration evaluation at Day 28, focused on children aged

This study has been approved by the Institutional Review Boards (IRB) of all participating centres. Written informed consent will be obtained from parents or legal guardians, and assent will be obtained from children aged 7 years and older. Results will be disseminated through peer-reviewed publications and conference presentations.

NCT07306234.

Hepatocellular carcinoma (HCC) recurs in most patients after curative treatment. Late recurrence (>2 years after curative treatment) typically indicates de novo tumours in the residual liver. Although contrast-enhanced computed tomography (CECT) and MRI are widely used for post-treatment follow-up, they each have limitations including radiation exposure, high cost and limited access. The abbreviated MRI using gadoxetic acid versus multiphasic CECT for detection of late recurrent HCC after curative treatment (AMRICT) trial aims to compare gadoxetic acid-enhanced abbreviated MRI using hepatobiliary phase imaging (HBP-AMRI) and multiphasic CECT for detecting late recurrent HCC after curative treatment.

This prospective multicentre intra-individual comparison trial will enrol 455 participants who have undergone surgical resection or local ablation for HCC and remained recurrence-free for over 2 years. Each participant will undergo two imaging sessions at 6±2 month intervals, using both HBP-AMRI and multiphasic CECT. The primary endpoint is the detection rate of all-stage HCC. The secondary endpoints include the false referral rate of all-stage HCC and detection and false referral rates of Barcelona Clinic Liver Cancer stage 0–A HCC and of stage 0 HCC. Structured imaging protocols and quality assessments will be implemented for both modalities.

This study was approved by the Institutional Review Boards of the three participating institutions (approval number: 2023–1630 (Asan Medical Center), H-2407-146-1556 (Seoul National University Hospital) and B-2410-929-401 (Seoul National University Bundang Hospital)) and registered at ClinicalTrials.gov (NCT06537193). Findings will be disseminated through peer-reviewed journals, scientific meetings, public forums and guideline updates.

ClinicalTrials.gov: NCT06537193. Participant enrolment began on 12 December 2024, and is ongoing.

Healthcare quality improvement increasingly relies on patient experience data, yet traditional survey modes face declining response rates and rising costs. Mobile web surveys have emerged as a promising alternative for improving response rates. The primary aim of this study was to investigate the effectiveness of mobile web surveys in improving response rates in South Korea’s Patient Experience Assessment. We also aimed to assess the impact of a mixed-mode approach integrating mobile web and follow-up telephone surveys across different demographic groups.

A randomised experimental design was employed to compare response rates as well as contact and cooperation rates among survey modes. A total of 4800 patients from four general hospitals were randomly allocated to telephone, mobile web or mixed-mode survey, with 1600 patients per mode. Each mode allowed five contact attempts through calls or mobile survey links. The mixed-mode survey included follow-up calls for mobile non-respondents.

The survey was conducted between October and November 2022 among patients discharged from four general hospitals in South Korea.

A total of 4800 patients aged 19 years or older who were hospitalised for more than 1 day and discharged within 2–56 days from four general hospitals were included in this study. Exclusion criteria included patients in day clinics, palliative care, paediatrics and neuropsychiatry, as well as those without personal information consent forms during hospital admission.

The primary outcome measure was the response rate for each survey mode. Secondary outcome measures included the contact rate and the cooperation rate.

The mobile web survey yielded an overall higher response rate (32.5%) than the telephone survey (22.4%), with the mixed-mode survey achieving the highest response rate (39.3%). Decomposing response rates revealed that while contact rates were comparable for both telephone and mobile web surveys, the cooperation rate was considerably higher for the mobile web survey (73.2%) compared with the telephone survey (52.2%). Substantial gender-age subgroup differences were found.

Adopting mobile web surveys for patient experience assessments, which aligns with the public’s preference for information and communication technologies, could significantly improve response rates in patient experience surveys.

KCT0011374 (post-results).

Alcohol consumption above recommended limits has been associated with increased cardiovascular disease (CVD) risk in observational studies. In particular, little is known about the association between high-risk drinking and cardiovascular health (CVH), as assessed by the American Heart Association’s Life’s Essential 8 (LE8) health metrics, in the context of community-based population datasets. Therefore, this study aimed to determine the relationship between high-risk drinking and CVH status using data from the 2016–2021 Korea National Health and Nutrition Examination Survey (KNHANES).

Cross-sectional secondary analysis study.

The 2016–2021 KNHANES.

This analysis included 18 500 adults aged 19 years or older.

High-risk drinking was defined as consuming seven or more drinks (or five cans of beer) in one sitting for men, and five or more drinks (or three cans of beer) for women, at least once a month. The frequency of high-risk drinking was categorised as follows: ‘rarely or never’, ‘less than once per month’, ‘at least once per month’, ‘once a week’ or ‘nearly daily’. We calculated an LE8 score for each of eight composite metrics, with each metric ranging from 0 to 100. LE8 total scores were categorised as 0–49, 50–79 and 80–100, representing low, moderate and high CVH, respectively. We used weighted log-linear regression models to analyse the relationship between high-risk drinking and CVH.

Nearly daily or weekly high-risk drinking was reported by 37.3% of men and 14.7% of women. The mean CVH score of groups with more frequent high-risk drinking decreased linearly in both sexes. Using the ‘nearly daily’ drinking group as the reference group, the exponential coefficients (exp(B)) showed that the total CVH score increased progressively as the frequency of high-risk drinking decreased in both men and women. Compared with the ‘nearly daily’ group, the total CVH score was 5% higher in the ‘once a week’ group (exp(B)=1.05, p

This study found that high-risk drinking was negatively associated with ideal CVH in Korean adults, and this association showed sex differences. Interventions targeting high-risk drinking may be more effective than focusing on overall alcohol consumption.

This study aimed to analyse patient-initiated compliment letters from a single institution, identify the key elements that patients value and offer actionable insights to enhance patient-centred care.

A retrospective, single-institution study using the Healthcare Complaints Analysis Tool (HCAT), text network analysis and latent Dirichlet allocation (LDA) topic modelling on patient compliment letters to pinpoint key valued care elements.

A newly established general hospital in Gwangmyeong, South Korea, opened on 22 March 2022.

A total of 1213 compliment letters were collected through the hospital’s feedback system, which accepted both online and on-site submissions between 25 March 2022 and 28 June 2024. Letters lacking substantive descriptive content and those containing purely administrative requests were excluded.

The HCAT was adapted to categorise positive statements into clinical, management and relationship domains, along with six stages of care. Inter-rater reliability was evaluated using Gwet’s AC1 statistic. A text network analysis, applying a term frequency–inverse document frequency approach, was conducted to identify prominent keywords. Subsequently, LDA was performed to extract thematic topics.

Most compliments concerned the ‘relationship’ domain (62%), particularly during the care in the ward stage (56%). Keyword analysis indicated that the most frequently mentioned terms were ‘gratitude’, ‘kindness’, ‘nurse’, ‘doctor’ and ‘heart/mind’, underscoring patients’ high valuation of positive interactions, professional competence and compassionate communication with medical staff. Topic modelling identified three primary topics, namely, ‘appreciation of nursing care’ (39%), ‘professionalism in surgery and treatment’ (35%) and ‘effective communication during consultations’ (26%).

Positive relationships with medical staff, particularly kindness, professionalism and effective communication, influence patient satisfaction. Patient compliment letters serve as important indicators of exceptional care and can inform quality improvement initiatives. Healthcare institutions should leverage these insights to enhance patient-centred services by strengthening patient–provider relationships and promoting a culture of excellence.

The COVID-19 pandemic threatened global HIV Test and Treat Efforts. We assessed whether it affected (1) the number of antiretroviral therapy (ART) initiations and (2) the proportion of timely ART initiations in people living with HIV (PLWH) globally.

Quasi-experimental, regression discontinuity design using routinely collected data from HIV clinics.

360 HIV care clinics across primary and secondary levels of care, participating in the International epidemiology Databases to Evaluate AIDS consortium, in 31 countries in Asia, Africa and the Americas.

177 391 PLWH (≥18 years old) who initiated ART 2 years before and 1 year after the onset of the COVID-19 pandemic in their country.

The primary outcome was the number of ART initiations per week; the secondary outcome was the proportion of timely ART initiations (ie, ART initiated within 7 days of enrolment). We assessed changes in these outcomes in the 52 weeks after compared to the 104 weeks before the pandemic onset, defined using each country’s peak Oxford Stringency Index score between January and June 2020.

Among 177 391 newly enrolled PLWH, 129 743 initiated during the pre-pandemic and 47 648 post-pandemic onset. 72.5% of ART initiations were timely pre-pandemic whereas 82.3% were during the pandemic. Absolute number of ART initiations remained stable during the pandemic period in 25 of 31 countries but decreased significantly in six countries: India (–5.0 p, 95% CI –9.2 to –0.7), Rwanda (–10.0 p, –18.6 to –1.4), Malawi (–33.4 p, –54.1 to –12.3), South Africa (–130.8 p, –188.6 to –73.1), Zimbabwe (–12.9 p, –20.0 to –5.8) and Togo (–19.6 p, –39.1 to –0.1). The proportion of timely initiations was stable in all countries except in Kenya (+4.2 pp, 95% CI +0.3 to +8.1) and in Mozambique (+2.7 pp, +0.5 to +4.9), where it increased significantly.

A deeper understanding of the factors that contributed to sustaining ART initiations, particularly in settings with stringent public health and social measures, is needed. These insights should inform preparedness strategies, resource allocation and policy development to ensure continuity of HIV services during future health emergencies, in line with World Health Organisation recommendations.

This study aimed to investigate the association between smoking behaviours during early pregnancy and the risk and severity of gestational diabetes mellitus (GDM), with a particular focus on smoking status, smoking intensity and secondhand smoke exposure.

Secondary analysis of prospectively collected cohort data.

Multi-centre study conducted in South Korea (Korean Pregnancy Outcome Study) between March 2013 and January 2017.

From 4537 pregnant women initially enrolled, 3457 singleton pregnancies were included after excluding cases with transfer, loss to follow-up, twin pregnancies, miscarriages and pre-existing diabetes mellitus. All participants were women of Korean ethnicity.

Primary outcome was GDM and its subtypes (A1GDM: diet-controlled; A2GDM: insulin-requiring). Secondary outcomes were associations with active smoking (before pregnancy and during early pregnancy), smoking intensity dose–response relationships (pack-years) and secondhand smoke exposure among never-smokers.

Among 3457 participants, 231 women (6.7%) were diagnosed with GDM (198 A1GDM, 33 A2GDM). Active smoking before pregnancy (adjusted OR (aOR) 3.98, 95% CI 1.58 to 9.30) and during early pregnancy (aOR 9.90, 95% CI 2.97 to 29.45) were significantly associated with A2GDM, while no significant association was observed with A1GDM. A clear dose-response relationship was observed, with smoking intensity >4 pack-years markedly increasing A2GDM risk (aOR 20.68, 95% CI 6.75 to 59.39). Detailed pack-year analysis showed 4–6 pack-years (aOR 20.57, 95% CI 5.80 to 65.46) and >6 pack-years (aOR 25.98, 95% CI 3.21 to 146.45). Among never-smokers, secondhand smoke exposure showed a borderline association with overall GDM risk (aOR 1.33, 95% CI 0.98 to 1.81).

Maternal active smoking before and during early pregnancy, as well as higher smoking intensity, was associated with an increased risk of pharmacologically treated GDM (A2GDM). Although secondhand smoke exposure did not reach statistical significance, the trend suggested a potential association with GDM risk among never-smokers. These findings provide important evidence for public health strategies for prenatal care, as smoking cessation and environmental smoke avoidance during prenatal and early antenatal care in women reduce the risk of gestational diabetes.

To evaluate how recurrent COVID-19 infections influence the clinical course of patients with chronic obstructive pulmonary disease (COPD), focusing on moderate-to-severe symptom flare-ups, all-cause mortality and long covid.

Nationwide retrospective cohort study.

Korean Health Insurance Review and Assessment database covering the entire Korean population between January 2020 and December 2023.

A total of 313 760 patients aged ≥40 years who met an established operational definition of COPD based on diagnostic codes and inhaled therapy prescriptions. Patients were stratified by the number of COVID-19 events: none, one, two or three or more.

The primary outcomes were moderate-to-severe COPD exacerbations and all-cause mortality. The secondary outcome was long covid, defined by WHO criteria using International Classification of Diseases (ICD)-10 codes persisting ≥2 months within 3 months after infection.

Among 313 760 patients, 154 095 (49.1 %) experienced at least one COVID-19 event. COVID-19 infection was associated with increased risk of exacerbations (adjusted HR (aHR) 1.64, 95% CI 1.62 to 1.66) and mortality (aHR 2.25, 95 % CI 2.19 to 2.31). Risk rose progressively with repeated infections, reaching an aHR of 2.41 for exacerbations and 2.93 for mortality after three or more events. Long covid was more frequent in patients with multiple infections, but most cases occurred after the first event, with diminishing occurrence after subsequent infections.

Recurrent COVID-19 infections in patients with COPD were linked to progressively higher risk of exacerbations and mortality, whereas the burden of long covid was greatest after the first infection. Preventing the initial infection and reducing reinfection risk remain critical components of COPD care in the post-COVID-19 era.

Statins are a cornerstone of cardiovascular disease prevention yet remain underused among eligible patients. Clinical decision support systems embedded in electronic health records (EHRs) are commonly used to encourage guideline-concordant prescribing. Interruptive reminders (eg, pop-ups) may be effective but interfere with clinical workflows and contribute to alert fatigue. Non-interruptive alerts are less intrusive, but their effectiveness remains unclear. The Interruptive versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC) trial is designed to evaluate the comparative effectiveness of interruptive and non-interruptive reminders on statin-prescribing rates.

INIRSHA-PC is a single-centre, pragmatic, three-arm, parallel-group randomised controlled trial embedded in the EHR at Vanderbilt University Medical Center. The trial will enrol adults aged 18–74 seen in primary care who are eligible for, but not currently prescribed, statin therapy. The planned sample size is 3000 patients (1000 per arm). Enrolled patients will be randomised 1:1:1 to (1) interruptive reminder, (2) non-interruptive reminder or (3) no reminder (usual care). The primary outcome is statin prescription within 24 hours of enrolment. Secondary outcomes are statin prescribing within 12 months and low-density lipoprotein cholesterol levels measured between 30 days and 12 months after enrolment. Enrolment began on 14 August 2024. The study is expected to be completed on 19 November 2025.

The trial has been approved by the Vanderbilt University Medical Center Institutional Review Board with waiver of patient informed consent (IRB number: 240419). Results will be disseminated through peer-reviewed publication and presentation at scientific conferences.

NCT06456658.

This study aimed to identify the predictors of burnout, anxiety and depression among healthcare professionals during the COVID-19 pandemic.

A secondary quantitative analysis of data from the Mental Health Research Canada (MHRC).

Healthcare professionals across Canada during the COVID-19 pandemic.

1439 Canadian healthcare professionals.

Data from MHRC, collected between April 2020 and January 2024, including sociodemographic factors and measures of burnout, anxiety and depression.

In total, 1439 participants were included in the analysis. Women (OR: 2.25; 95% CI 1.46 to 3.48), younger workers (OR: 2.29; 95% CI 1.29 to 4.06) and mental health professionals (OR: 2.59; 95% CI 1.11 to 6.01) were more likely to experience burnout. Meanwhile, men (OR: 2.05; 95% CI 1.40 to 3.00), younger workers (OR: 8.58; 95% CI 4.12 to 17.86) and physicians (OR: 2.01; 95% CI 1.16 to 3.46) had an increased likelihood of being diagnosed with anxiety. Similar findings were obtained for depression, where men (OR: 1.74; 95% CI 1.18 to 2.56), young workers (OR: 5.22; 95% CI 2.68 to 10.18), physicians (OR: 2.11; 95% CI 1.22 to 3.64), visible minorities (OR: 2.29; 95% CI 1.55 to 3.38) and those with a physical impairment (OR: 4.79; 95% CI 2.55 to 8.97) were more likely to receive a diagnosis since the COVID-19 pandemic.

These findings underscore the need for targeted clinical interventions among healthcare professionals during and beyond public health emergencies. Specifically, healthcare institutions should implement accessible mental health programmes, regular psychological assessments and workload management strategies for those who face increased vulnerabilities to mental health struggles.

Pay-for-performance (P4P) programmes are increasingly implemented in healthcare to improve quality of care, but their application in dentistry remains limited. Evidence-based approaches are needed to guide incentive design in value-based dental care, particularly for preventive services, such as topical fluoride application in children. We sought to assess the potential cost-effectiveness of P4P incentives for increasing topical fluoride application among children and to illustrate how simulation modelling can identify conditions under which subgroup-specific incentive levels may be optimal.

We developed and validated a decision-analytic microsimulation model using nationally representative data from the National Health and Nutrition Examination Survey (NHANES 2011–2016) to simulate a cohort of 100 000 US children aged 0–19 years over a 10-year period starting in 2024. The model incorporated heterogeneity in demographic and clinical characteristics to estimate changes in dental caries, quality-adjusted life years (QALYs) and healthcare costs under hypothetical P4P programmes that increased topical fluoride coverage by 2.5% to 50% relative to the baseline rate of 24.5%, with incentive amounts ranging from 2.5% to 50% of provider salary. Sensitivity analyses assessed robustness to variation in key parameters.

Cumulative incidence of dental caries, QALYs, total healthcare costs and incremental cost-effectiveness ratios (ICERs).

Across a broad range of incentive–coverage combinations, P4P incentives were generally cost-effective. For example, a 10% salary-based incentive linked to a 5% relative coverage increase reduced 186.3 cases of tooth decay and yielded 33.8 QALY gains per 10 000 children, resulting in an ICER of $8501 per QALY gained. The intervention was estimated to be cost-saving at coverage increases ≥27.5%. Subgroup analysis indicated larger absolute benefits among racial/ethnic minority children.

P4P incentives to increase topical fluoride application in children could be cost-effective, and potentially cost-saving, under certain conditions. Cost-effectiveness modelling can help define incentive–coverage combinations that are likely to promote both efficiency and equity. Empirical studies are needed to validate provider responsiveness and establish achievable benchmarks for programme design.

In-hospital cardiac arrest (IHCA) is associated with high mortality and serious neurological sequelae. Although medical alert systems have evolved, the ability of these systems to influence changes in IHCA incidence and aetiology remains limited.

Retrospective observational cohort study.

A single tertiary hospital in South Korea, covering tertiary care levels.

A total of 1994 adult patients (≥18 years) who experienced 2121 episodes of IHCA between January 2011 and December 2019. Patients with out-of-hospital cardiac arrest, those aged ≤18 years and those with do-not-resuscitate orders were excluded. The mean age of patients was 63.0 years (SD, 14.6); 64.1% were male.

Not applicable.

The incidence and temporal trends of IHCA were stratified by aetiology (cardiac vs non-cardiac). Additional analyses examined changes in arrhythmic versus non-arrhythmic causes over time using Poisson regression.

Cardiac arrhythmia was the most common cause of IHCA (314 of 2121, 14.8%; incidence: 0.42/1000 admissions), including ventricular tachycardia (n=86), ventricular fibrillation (n=87) and Torsades de Pointes (n=79). Respiratory failure was the second most common cause (266 of 2121, 12.5%; incidence: 0.36/1000 admissions). The incidence of IHCA due to respiratory failure in 2011 was 0.63/1000 admissions, which decreased to 0.20/1000 admissions by 2019 (β=0.883, 95% CI 0.842 to 0.926, p for trend 0.007; Poisson p

IHCA causes have shown significant temporal shifts. Arrhythmia has become the leading cause of IHCA, with incidences remaining stable, whereas a marked decrease has been observed in respiratory-related IHCA. Therefore, enhanced in-hospital cardiac monitoring systems are required for early detection.

The home-based primary care cohort was set up to identify the characteristics of Home-Based Primary Care (HBPC) users across three domains: health-related information, utility of healthcare service and care-related information.

A total of 407 patients enrolled in five HBPC centres were recruited between January 2023 and March 2024. The baseline survey was conducted among 332 participants who provided informed consent for both study participation and home visits. The second wave of data collection is scheduled to take place 6 months after enrolment, while the third wave will be conducted 12 months post-enrolment. During each home visit, trained interviewers administered structured survey questionnaires. On completion of the 12-month follow-up period, the dataset will include survey data, intervention records from the five participating HBPC centres, home mortality status and institutionalisation risk linked to each participant.

This study examines HBPC in Korea, integrating the Widely Integrated Services in Home model with the long-term care insurance system. Among participants, 30.1% lived alone, and 74.1% were homebound, showing similarities to findings from a US HBPC study. Analysing cohort data, this study evaluates the impact of HBPC on healthcare utilisation, aligning with international findings on reduced hospitalisations and costs. As the first HBPC effectiveness study in Korea, it highlights its role in enhancing care for homebound older adults and shaping national health policies.

Data on the number of interventions by profession, institutionalisation and hospitalisation status and duration, and death at home occurrence are being separately collected from five HBPC centres and will be included in the analysis. The analysis will examine associations between these variables to identify risk factors influencing institutionalisation. Additionally, this study plans to link the dataset with the National Health Insurance Service-Senior (NHIS-Senior) customised cohort for further analysis.

Neutropenic fever (NF) has a crude mortality rate of 3–18%. International guidelines recommend that all patients with NF receive ultrabroad-spectrum antibiotics (UBSAs) within 1 hour of emergency department (ED) registration. However, over 70% patients presenting to hospital with suspected NF (sNF) cannot access absolute neutrophil count (ANC) result within 1 hour, do not have NF and do not require UBSAs. In ED and hospitalised patients with sNF, we hypothesise that the ASTERIC protocol effectively and safely reduces the use of UBSAs compared with standard care alone.

This pragmatic, parallel, multicentre, type 1, hybrid effectiveness-implementation, stepped-wedge, before-and-after, cluster randomised controlled trial aims to evaluate whether antibiotic prescribing can be safely reduced through implementing a multifaceted antibiotic stewardship intervention (ASTERIC) in adult patients with sNF presenting to EDs. The sNF was defined as a fever with a single oral temperature of ≥38.3°C (101°F) within 24 hours before ED registration or a temperature of ≥38.0°C (100.4°F) sustained over a 1-hour period, following last chemotherapy or targeted therapy within 6 weeks for any solid tumour, or in any period following therapies against leucaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma or recipient of HSCT. The study will involve eight hospitals in Hong Kong with variable baseline practice. We will include 704 adult patients (352 patients in pre-implementation and post-implementation periods, respectively) with sNF (tympanic temperature ≥38.3°C) and 48 staff participants (6 staff participants in each hospital). Healthcare professionals will receive a multifaceted stewardship intervention consisting of risk assessment tools, fast-track ANCs, a decision tool for patient management and antibiotic use, supported by an educational package and staff interaction programmes (ASTERIC protocol). Patients’ blood ANC, and cancer therapy and chronic illness therapy scores will be measured. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and Proctor conceptual frameworks will be followed for evaluation of implementation. The main outcome measures are the mean total dose of UBSAs prescribed in 7 days and serious adverse events at 30 days. Data analysis will incorporate intention-to-treat, per-protocol and as-treated analyses for service outcomes (effectiveness, safety, quality of life assessments and cost-effectiveness) and mixed methods for implementation outcomes, informed by the Theoretical Domains Framework. We expect that the study results will inform health policy with improvement in hospital services in treating stable sNF, evidenced by improved safe antibiotic stewardship, early antibiotic de-escalation and reduced costs and length of stay.

The institutional review boards of all study sites approved this study. This study will establish the ASTERIC protocol safely improves antibiotic stewardship and clinical management in adult patients with sNF. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities. All patients with sNF will be influenced by the new protocol which is agreed at hospital level. Randomisation is at hospital level, not patient level. Patient consent is sought for follow-up and data access, not for treatment. Staff consent is sought for interviewing.

NCT06794320.