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).

To evaluate the effect of lobeglitazone on renal disease progression in patients with type 2 diabetes mellitus using longitudinal real-world data.

Retrospective cohort study.

Hospital-based Common Data Model database.

A total of 14 712 adults with type 2 diabetes mellitus who visited the Diabetes Center of Ewha Womans University Mokdong Hospital between 2013 and 2019 were identified. A 1:2 propensity score matching was performed to compare patients treated with lobeglitazone plus metformin with those receiving metformin monotherapy, sulfonylurea plus metformin, or a dipeptidyl peptidase-4 (DPP4) inhibitor plus metformin.

Treatment with lobeglitazone plus metformin compared with metformin monotherapy, sulfonylurea plus metformin or DPP4 inhibitor plus metformin.

Renal progression, defined as initiation of renal replacement therapy, a sustained ≥30% decline in estimated glomerular filtration rate (eGFR) from baseline, or doubling of serum creatinine with a concurrent eGFR ≤45 mL/min/1.73 m².

The HR of renal progression was 0.84 (95% CI 0.58 to 1.21) in the lobeglitazone plus metformin compared with metformin monotherapy, 1.00 (95% CI 0.79 to 1.27) compared with sulfonylurea plus metformin group, 1.10 (95% CI 0.84 to 1.44) compared with DPP4 inhibitor plus metformin group after adjusting for multiple variables. Subgroup analyses demonstrated significant interactions by sex in the comparison with metformin monotherapy (P for interaction=0.0179) and by glycaemic control in the comparisons with sulfonylurea plus metformin (P for interaction=0.0161) and DPP4 inhibitor plus metformin (P for interaction=0.0006), suggesting potential heterogeneity in treatment effects.

Lobeglitazone showed renal outcomes comparable to those of other antidiabetic medications, with a possible heterogeneity in treatment effects according to sex and glycaemic control.

This study developed and validated the precaution theory-based Environmental Parenting Scale (EPS) to assess proactive parental behaviours that reduce children’s environmental risk exposure. Existing measures lack theory-based assessments of preventive parenting under environmental uncertainty.

This study involves the development of a scale based on Kriebel’s precaution theory to construct measures of environmental parenting behaviour.

For exploratory factor analysis, 216 participants with children under the age of 18 were recruited from Jeonju, Cheonan and Milyang in South Korea between 16 September 2024 and 21 September 2024 using convenience sampling. Content validity was confirmed by three professionals.

The preliminary items were gathered through a literature review and in-depth interviews with 10 participants. We assessed convergence validity, known-group validity and internal consistency reliability. Exploratory factor analysis revealed a cumulative variance of 65.73% for explaining the target behaviours.

The EPS comprises 21 items across four factors: hygiene management, natural product use, prevention of toxin exposure and protection from radiation. Convergent validity with the personal environmental health behaviours scale was supported (r=0.75, p

The EPS is a valid and reliable scale for measuring environmental parenting behaviours in the context of climate change and environmental diseases.

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.

Pain, including phantom limb pain (PLP), residual limb pain (RLP) and low back pain (LBP), is highly prevalent after lower limb amputation (LLA) and compromises quality of life. Although both pain and function have been studied extensively, methods of assessment and reporting vary, limiting comparability. A clearer overview of how these domains are measured and interrelated is needed to guide research and practice.

To synthesise evidence on how postamputation pain and functional outcomes have been assessed and reported in adults with LLA, and to examine reported relationships between pain and mobility/function.

Scoping review guided by Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

MEDLINE, Embase and PsycINFO (inception to 15 August 2025).

Quantitative studies that measured pain and functional outcome in adults with LLA.

Two reviewers independently extracted study characteristics, pain measures and functional outcomes in Covidence; findings were narratively synthesised.

Eighty-four studies were included. RLP (n=46), LBP (n=32) and PLP (n=28) were most frequently examined. Pain was mainly assessed by self-report scales; mobility was typically assessed by clinical tests and less often by biomechanical instrumentation. PLP was associated with altered gait and balance deficits; RLP with limited walking distance, asymmetric weight-bearing and reduced community participation; LBP with gait asymmetry, trunk–pelvis discoordination and increased energy cost of walking.

Postamputation pain is often linked to reduced mobility and functional limitations. However, heterogeneous definitions and inconsistent methodology hinder synthesis across studies. Future research should combine validated pain scales with objective analysis, wearable sensors and musculoskeletal modelling to clarify mechanisms and inform rehabilitation.

To evaluate whether type 2 diabetes mellitus (T2DM) presence and severity are associated with differences in global and domain-specific cognitive function among US adults, using standardised Montreal Cognitive Assessment (MoCA) testing.

Cross-sectional study

Three U.S academic medical centres participating in the Artificial Intelligence–Ready and Equitable Atlas for Diabetes Insights (AI-READI) study.

Adults aged ≥40 years enrolled in the AI-READI cross-sectional study at three US academic medical centres were eligible. The study excluded individuals with type 1 diabetes, pregnancy or inability to speak, read and understand English. For this secondary analysis, 1067 participants from the first publicly released AI-READI data set who had MoCA data and assigned glycaemic status were included. Participants were classified into four prespecified glycaemic groups: controls without diabetes (n=371), pre-diabetes (n=239), medication-controlled type 2 diabetes (n=323), and insulin-dependent type 2 diabetes (n=129).

The primary outcome was global cognitive function measured by the MoCA total score. Secondary outcomes included MoCA domain scores and the prevalence of cognitive impairment, defined as MoCA

Significant differences in MoCA total scores were observed across glycaemic groups (p

Individuals with more advanced T2DM, particularly those on insulin, had significantly higher risk of cognitive impairment. These findings support routine cognitive screening in patients with T2DM, especially those on insulin therapy. Early identification of cognitive impairment may improve diabetes management and cognitive outcomes.

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.

This study aimed to determine whether certain lifestyle factors, specifically alcohol consumption, smoking, physical activity, sleep duration and sleep quality, are associated with an increased risk of metabolic syndrome (MetS) and to assess how changes in lifestyle behaviours over time influence MetS prevalence in the middle-aged Korean population.

Community-based, prospective cohort study.

South Korea, baseline in 2017–2019 and follow-up in 2020–2022.

The study included 1436 adult individuals aged ≥30–59 years.

The primary outcome of this study was the prevalence of MetS at follow-up, determined according to established diagnostic criteria. Secondary outcomes included the association between MetS and five key lifestyle factors: alcohol consumption, smoking, physical activity, sleep quality and sleep duration. Lifestyle changes were categorised into four groups based on stability between baseline and follow-up assessments. Outcome measures remained consistent with the study’s initial protocol, with no modifications to the planned variables or measured criteria.

The prevalence of MetS increased from 15.3% at baseline to 19.6% at follow-up. At follow-up, insufficient physical activity (OR=1.42, 95% CI 1.06 to 1.92) and poor sleep quality (OR=1.37, 95% CI 1.02 to 1.84) were significantly associated with MetS. Among lifestyle change patterns, long-term unhealthy physical activity (OR=1.57, 95% CI 1.03 to 2.39) and sleep quality (OR=1.50, 95% CI 1.01 to 2.24) behaviours were associated with an increased risk of MetS. Poisson regression analyses of incident cases showed that only unfavourable changes in sleep duration were significantly associated with incident MetS (rate ratios=1.74, 95% CI 1.02 to 2.95). However, no significant associations were observed for other lifestyle change patterns, including behaviours that improved or worsened over time, and no meaningful associations were identified for non-significant lifestyle factors, such as smoking and alcohol consumption.

The prevalence of MetS was associated not only with individual lifestyle factors but also with long-term patterns of unhealthy behaviours, with persistent shortage of physical activity, poor sleep quality and inadequate sleep duration identified as significant contributors to increased MetS risk. Future research should explore a broader range of risk factors over longer follow-up periods to better understand the long-term impact of lifestyle modifications on MetS development.

Type 2 diabetes mellitus has been associated with an increased risk of cognitive decline and dementia, with patients being 1.5–2 times more likely to develop these conditions. While both sodium-glucose co-transporter 2 (SGLT2) inhibitors and thiazolidinediones (TZDs) have shown potential neuroprotective effects in previous studies, their comparative effectiveness for preventing neurodegenerative outcomes has not been established. This study aimed to compare the risk of stroke, dementia and Alzheimer’s disease (AD) between patients treated with SGLT2 inhibitors and those treated with TZDs.

Multicentre, retrospective, observational, new-user, active-comparator cohort study.

Electronic health record-based databases from 11 secondary and tertiary institutions in South Korea from 1 January 2014 to 31 July 2025. The study period began in 2014, following the post-marketing surveillance initiation of SGLT2 inhibitors in Korea (November 2013), to ensure adequate drug availability and clinical adoption.

Patients aged 40 years or older who were newly prescribed either SGLT2 inhibitors or TZDs without prior exposure.

Propensity score matching (1:1) was performed using sex as the primary covariate due to data availability constraints in the Observational Medical Outcomes Partnership Common Data Model framework. The HRs with 95% CIs were measured via Cox regression analysis.

The study analysed 24 172 matched pairs for stroke outcomes (40 483 person-years in the SGLT2 inhibitor group and 39 363 person-years in the TZD group), 25 111 matched pairs for dementia (41 924 person-years in the SGLT2 inhibitor group and 40 726 person-years in the TZD group) and 25 237 matched pairs for AD (42 139 person-years in the SGLT2 inhibitor group and 40 895 person-years in the TZD group) across 11 participating hospitals. After a 1:1 propensity score matching, the SGLT2 inhibitors showed no significant difference in stroke risk (HR 1.18, 95% CI 0.62 to 2.23, p=0.62), while having significant reductions in dementia risk (HR 0.66, 95% CI 0.45 to 0.98, p=0.04) and AD risk (HR 0.54, 95% CI 0.35 to 0.83, p=0.005). Moreover, these protective effects for neurodegenerative outcomes were shown to be consistent across multiple hospital sites.

SGLT2 inhibitors are associated with a reduced risk of dementia and AD compared with TZDs in patients aged 40 years or older with type 2 diabetes and have neutral effects on stroke risk. These findings confirm the potential selective neuroprotective benefits of SGLT2 inhibitors for neurodegenerative outcomes, which may inform therapeutic decision-making for diabetic patients at risk of cognitive decline.

Cutaneous vascular anomalies and scars can cause significant physical and psychosocial difficulties for children, but can be ameliorated with pulsed dye laser (PDL) and neodymium-doped yttrium aluminium garnet (Nd:YAG) laser treatment. Given that multiple rounds of treatment are often required, and that the procedures are painful, achieving adequate analgesia is imperative in this setting. Paediatric procedural pain management guidelines suggest that multimodal non-pharmacological and pharmacological analgesia should be used for such procedures; however, the place of topical anaesthetic (TA) within this paradigm has not been adequately studied.

This feasibility and pilot trial will investigate the feasibility of performing a randomised, placebo-controlled trial assessing pain intensity in children receiving TA in conjunction with other multimodal analgesic methods for laser procedures. The primary objective of the trial will be to assess feasibility, and secondary objectives will be to assess pain intensity, acceptability of trial procedures to participating families and their clinical team, to assess the laser treatment response, and obtain data necessary for full-scale trial sample size calculations.

The trial will include 50 children aged 0–18 years old who are undergoing awake PDL and/or Nd:YAG laser treatment for scars or vascular anomalies. Patients will be randomised in a 1:1 ratio to receive either TA cream (lidocaine 2.5%/prilocaine 2.5% (Numit 5% cream, Ego Pharmaceuticals, Braeside, VIC, Australia)) or a placebo, along with our unit’s standard multimodal analgesic agents for laser treatment (including paracetamol, ibuprofen or oxycodone and intraprocedural sucrose solution or intranasal fentanyl). Investigators, participants and their caregivers, and clinicians will be blinded to participant allocation.

The primary outcome of the trial will be trial feasibility based on pre-specified criteria. The secondary outcome of pain intensity will be assessed by observer, caregiver and self-reported measures, and the secondary outcome of trial method acceptability with a Theoretical Framework of Acceptability questionnaire. The assessment of laser treatment response will be assessed with lesion-specific evaluation tools. Feasibility and acceptability data will be summarised using descriptive statistics. The association between treatment groups and pain scores, treatment groups and laser treatment response will be investigated using a univariable linear regression model, with the effect estimate reported as mean difference and 95% CI.

This trial has undergone ethical review and has been granted approval by the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (ref HREC/23/QCHQ/91002) and the Griffith University Human Research Ethics Committee (ref 2023/308). The protocol has been prospectively registered in the Australian and New Zealand Clinical Trials Registry (ACTRN12623000494639). Results of this trial may be presented at scientific meetings and will be published in a peer-reviewed journal. Participating families that have indicated an interest in trial results will receive a plain-language summary of the trial results by email.

ACTRN12623000494639.

Providing peer support can benefit youth peer support workers (peers)et by supporting self-determination, recovery and resilience to self-stigma. There is a need to clarify the role of the organisation in providing benefits for peers. We aimed to identify the organisational contexts and mechanisms that result in the creation of healthy workplaces for peers.

Rapid realist review guided by the Realist and Meta-Narrative Evidence Syntheses–Evolving Standards guidelines and Pawson’s iterative approach.

MEDLINE, CINAHL, PsycINFO, ERIC, SocINDEX, Google Scholar and Embase were searched from 1979 to 2025.

We included qualitative and quantitative peer-reviewed studies and grey literature that captured characteristics of organisational practices and employment considerations in youth peer support programmes.

Articles were screened independently by multiple reviewers. Inclusion criteria were adjusted to capture literature on organisational practices, and employment considerations for youth peer support programmes. Data were extracted and analysed retroductively to develop Context-Mechanism-Outcome Configurations (CMOCs).

Five employment-related risks to peer well-being were identified: (1) difficulty entering the job market, (2) lack of role clarity, (3) pressure to live up to ideals, (4) retraumatisation and (5) stigma. Six CMOCs were developed; all focused on the creation of equitable employment and supporting peer development and empowerment were developed.

Community-based mental health organisations can facilitate equitable peer employment through strategies that reduce professional stigma, enhance peer resilience and promote professional and personal development. Policy reform that addresses precarious work conditions is needed to support healthy work environments.

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.

Cutaneous T cell lymphoma (CTCL) is a group of non-Hodgkin lymphomas that primarily affects the skin and can mimic inflammatory dermatoses. Unlike many skin diseases, CTCL can lead to disabling symptoms, and advanced CTCL can even be fatal. Early studies investigating health-related quality of life (HRQOL) in patients with mycosis fungoides (MF) and Sézary syndrome (SS), common subtypes of CTCL, demonstrated significant impairment across numerous domains. The aim of this current study is to develop a core domain set (CDS) to identify the essential aspects of MF/SS that influence HRQOL that should be measured in therapeutic clinical trials. In the future, this set of core concepts will be used to identify the best patient- reported outcome measure(s) (PROM) for HRQOL for MF/SS clinical research.

Multiple strategies will be used to generate candidate concepts: systematic review of the literature, qualitative study and a survey study of healthcare providers. A Delphi consensus process including a comprehensive group of stakeholders (patients, caregivers/care partners, a multidisciplinary group of healthcare professionals, patient advocacy groups, pharmaceutical industry representatives, methodologists and government agencies) will be used to achieve consensus. Statistical corrections for multiple significance testing and false positive findings will be undertaken.

The study was submitted for and received institutional review board approval at the University of Washington (IRB# STUDY00018890 and STUDY00019407). Informed consent will be obtained from all participants where necessary. We will disseminate our findings through peer-reviewed, open access publications and presentations at national/international conferences. We will provide a plain language summary in lay terms for patients and families to patient advocacy groups for distribution to their network.

The protocol is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database.

Mobile health (mHealth) technologies have become increasingly popular for monitoring mental health symptoms and lifestyle behaviours, and are largely reported to be feasible and acceptable to users. However, to date, the efficacy of such technologies to improve perinatal mental health outcomes has been mixed. Within the perinatal context, much of this work has been done in the context of postpartum depression, stemming from electronic health records as well as cohort studies. There is, however, a dearth of studies focusing on depression in pregnancy, and machine learning-based clinical decision support systems remain underexplored. The HappyMums application has been developed to meet this need, and its use across Europe will be tested in this study.

A total of 1000 pregnant people currently suffering from, or at risk of, antenatal depression will be recruited across six countries. All participants will be between 13 and 28 weeks’ gestation and will be given access to the new purposefully developed HappyMums mobile application, to use from enrolment until 2 months postpartum. The application leverages passively collected data from smartphone sensors relating to physical activity and behaviour, as well as requiring active engagement from the user to complete mental health questionnaires and ‘game-like’ activities. Digital data types will be combined with traditional mental health measurement methods, such as standardised questionnaires and interviews, to develop novel predictive models capable of identifying mental health trajectories in women at risk of developing antenatal depression and to test the app’s utility for use as personalised risk prediction and depression identification tool. The primary outcome of this study is to determine what proportion of users will continue to use the mobile application and engage with its tasks and activities at least weekly, while secondary exploratory outcomes include assessing usability of the app and testing the predictive ability of a novel machine learning-based model. These outcomes will, for the first time, be assessed by integrating active as well as passive data.

Ethical approval has been granted by local research ethics committees in each recruiting centre. At King’s College London (leading the clinical study), the study was reviewed by the East of England—Essex Research Ethics Committee and granted favourable opinion (REC reference 24/EE/0129). All other sites collecting participant data have the study approved for local delivery. Findings relating to the primary and secondary outcomes will be submitted for publication in open access, peer-reviewed journals, as well as presentations at conferences as symposia or posters. Findings will be made available to a non-specialist audience through open access digital mental health magazines and promotion on social media.

NCT06578845.