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Effect of COVID-19 pandemic on ART access and timely initiation in people living with HIV in 31 countries: a regression discontinuity design study

Por: Ben Farhat · J. · Messou · E. · Borse · R. · Varela Bustillo · D. · Madimabe · M. · Nash · D. · Byakwaga · H. · Shah · N. S. · Ezechi · O. · Pujari · S. · Veloso · V. G. · Hobbins · M. · Murenzi · G. · Mkwashapi · D. · Hogan · B. · Choi · J. Y. · Minga · A. · Crabtree-Ramirez · B. · Twizer
Objectives

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.

Design

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

Setting

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.

Participants

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.

Primary and secondary outcome measures

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.

Results

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.

Conclusions

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.

Harm reduction and pharmacy practice: a scoping review of services for people who use drugs provided by pharmacy staff

Por: Navarrete · J. · Berg · E. · Hughes · C. · Salokangas · E. · Taylor · M. · Kung · J. Y. · Johnson · J. A. · Hyshka · E.
Objectives

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.

Design

Scoping review.

Data sources

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

Study selection

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

Data extraction

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.

Results

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.

Conclusion

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.

Association between smoking behaviours during early pregnancy and the severity of gestational diabetes mellitus: a secondary analysis of prospectively collected cohort data in Korea

Por: Lim · J. H. · Joo · E. H. · Han · H.-J. · Ko · J. S. · Chung · B. · Kim · J. W. · Kim · J. Y. · Choi · Y. J. · Yang · S. J. · Han · Y. J. · Kwak · D. W. · Lee · H. J. · Ryu · H. M.
Objective

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.

Design

Secondary analysis of prospectively collected cohort data.

Setting

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

Participants

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.

Secondary outcome measures

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.

Results

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).

Conclusions

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.

Lower versus standard dose-intensity continuous renal replacement therapy: a protocol for a systematic review and meta-analysis

Por: Lumlertgul · N. · Kusirisin · P. · Kung · J. Y. · Duquette · D. · Fujii · T. · Zarbock · A. · Wald · R. · Bagshaw · S. M.
Introduction

The 2012 Kidney Diseases Improving Global Outcomes clinical practice guideline recommends prescribing continuous renal replacement therapy (CRRT) doses in patients with acute kidney injury (AKI) between 20 and 25 mL/kg/hour, with a need to consider further augmentation to 25–30 mL/kg/hour. Observational data have shown that lower-dose CRRT (

Methods and analysis

Ovid MEDLINE, Ovid Embase, CINAHL and Cochrane Library will be searched for studies from inception to present. We will evaluate the risk of bias using the modified Cochrane tool for randomised controlled trials and the Cochrane Risk of Bias In Non-randomised Studies—of Interventions tool for cohort studies. Two reviewers will independently complete study selection, data extraction and bias assessment. Inclusion criteria will be randomised controlled trials and observational studies (cohort) including patients with AKI receiving CRRT. The exposure will be lower dose-intensity CRRT (

Ethics and dissemination

Ethics approval is not required as primary data will not be collected. Findings of this review will be disseminated through peer-related publication.

PROSPERO registration number

CRD420251135606.

Sociodemographic and maternal-related correlates of childrens movement behaviours from preschool to adolescence in Singapore: a longitudinal cohort study

Por: Tan · S. Y. X. · Edney · S. M. · Padmapriya · N. · Tan · S. L. · Chong · Y. S. · Tan · K. H. · Yap · F. · Godfrey · K. · Lee · Y. S. · Eriksson · J. G. · Bernard · J. Y. · Müller-Riemenschneider · F.
Objectives

Current evidence is unclear due to methodological limitations. We bridge critical knowledge gaps by quantifying the longitudinal changes in movement behaviours and their correlates from early childhood through adolescence.

Design

Longitudinal observational cohort study.

Setting

General healthy child and adolescent sample in Singapore.

Participants

Growing Up in Singapore Towards healthy Outcomes study participants.

Primary and secondary outcome measures

We used wrist-worn accelerometry and proxy-reported data to examine movement behaviours (sleep, inactivity, light physical activity (PA; LPA) and moderate-to-vigorous PA (MVPA) and screen-viewing) at ages 5.5, 8, 10 and 12 years and the sociodemographic and maternal lifestyle-related correlates using linear regression models with generalised estimating equations.

Results

Among 837 children, sleep, LPA and MVPA declined by 3% (from 9.1 to 8.8 hours/day), 24% (from 5.8 to 4.4 hours/day) and 44% (from 71.3 to 40.1 min/day), respectively, while inactivity and screen viewing increased by 26% (from 8.0 to 10.1 hours/day) and 155% (from 1.8 to 4.6 hours/day), respectively, from ages 5.5 to 12 years. The greatest annual increase in inactivity (0.6 hour/annum) and screen-viewing (0.8 hour/annum) and decrease in LPA (0.3 hour/annum) and MVPA (10.4 min/annum) occurred from ages 8 to 10 years. Girls of Malay ethnicity and lower socioeconomic status, and whose mothers had less favourable movement behaviours, had significantly less sleep, higher inactivity and screen-viewing and/or lower PA. Maternal PA levels and/or sitting time were associated with children’s sleep, inactivity and MVPA up to age 8 years, while maternal sitting and screen-viewing behaviours were associated with children’s screen-viewing at all ages.

Conclusions

Using contemporaneous datasets relevant to the present day, we confirmed that children become less physically active and have longer screen-viewing as they transition into adolescence and highlighted characteristics to be prioritised in future interventions.

A patient-mediated strategy to improve nutrition care after transition from hospital to home for pancreatic cancer surgery: a pilot randomised controlled trial study protocol

Por: Turner · K. · Milano · J. · Santiago · C. · Coutinho · J. · Sprow · O. · Hume · E. · Nardella · N. · Alishahi Tabriz · A. · Islam · J. Y. · Hodul · P. J.
Introduction

Nutrition counselling is recommended after pancreatic cancer surgery given the complex nutritional problems patients experience. In practice, access and delivery of nutrition counselling after pancreatic surgery varies across settings. To address this gap, our study team developed the Support Through Remote Observation and Nutrition Guidance (STRONG) programme, an implementation strategy that addresses common barriers to nutrition care delivery in oncology.

Methods and analysis

The STRONG programme includes a standardised protocol to specify the timing and amount of nutrition counselling that should be delivered and patient-mediated implementation strategies including collection of patient-reported information, an educational brochure summarising common nutrition problems and recommended dietary strategies after pancreatic surgery and a question prompt list for the patient-dietitian encounter. A pilot randomised controlled trial will be conducted to assess the feasibility and acceptability of the STRONG programme compared with usual care in pancreatic cancer surgery patients after hospital discharge (n = 80). The trial is designed to be pragmatic and integrated into existing workflows and clinic teams. The primary goal will be to compare feasibility and acceptability outcomes against pre-planned benchmarks. Data will be collected from patients and caregivers and healthcare providers who assist with STRONG implementation. Secondary goals include collecting preliminary data on effectiveness and implementation outcomes that will support a future definitive hybrid implementation-effectiveness trial.

Ethics and dissemination

This study was approved by the Moffitt Cancer Center Institutional Review Board of Record, Advarra (Pro00071143). Participants will be required to provide written consent prior to enrolment. Study findings will be disseminated through plain language summaries, conference abstracts and peer-reviewed publications.

Trial registration number

ClinicalTrials.gov NCT06001268. Registered on 21 August 2023, prior to participant enrolment.

Effectiveness of poliovirus environmental surveillance in Ghana: an indicator-based performance evaluation across seven regions, 2018-2022

Por: Obodai · E. · Asante Ntim · N. A. · Duker · E. O. · Gberbi · E. · Antwi · C. N. · Mensah · J. Y. · Odame · D. · Boakye · J. D. · Bimpong · S. A. · Agbotse · G. D. · Odoom · N. · Adams · P. L. · Acquah · N. K. · Dickson · A. E. · Odoom · C. · Achempem · K. K. · Baffoe-Nyarko · I. · Egbi
Objective

To evaluate the performance of Ghana’s environmental surveillance (ES) system for poliovirus (PV) detection from 2018 to 2022 using standardised indicators developed by the WHO and the US Centers for Disease Control and Prevention.

Design

A retrospective performance evaluation using 10 key indicators benchmarked against global targets for PV surveillance.

Setting

Seven regions across Ghana, participating in the national ES programme implemented under the Global Polio Eradication Initiative.

Surveillance coverage

Wastewater sampling was conducted at designated ES sites, supported by field collection teams and laboratory personnel responsible for sample acquisition, processing and reporting of PV detection results.

Outcome measures

Detection rates of PV and non-polio enteroviruses (NPEVs), timeliness of sample collection and reporting, data quality and system stability.

Results

A total of 738 wastewater samples were collected. The system demonstrated high sensitivity, detecting circulating vaccine-derived PV type 2 in 51 (6.9%) of samples, Sabin PV types 1 and 3 in 61 (9.5%) and 114 (17.8%), respectively, and NPEVs in 491 (66.5%) of samples. Over 80% of samples met the recommended 21-day collection-to-reporting time frame. Data quality exceeded the ≥80% threshold, and workflows remained stable throughout the evaluation period.

Conclusions

Ghana’s ES system for PV was found to be flexible, stable and effective in generating high-quality data for early detection and public health response. These findings underscore the system’s critical role in supporting polio eradication efforts and highlight its potential as a model for surveillance in similar settings.

Singing interventions for people living with Parkinsons: a systematic review and meta-analysis

Por: Irons · J. Y. · Sheffield · D.
Objectives

To evaluate the effects of singing interventions on well-being, mental health and communication, motor and respiratory functions through meta-analysis and to examine the practices used in the singing interventions.

Design

Systematic review and meta-analysis.

Inclusion criteria

Both randomised and non-randomised studies, involving participants living with Parkinson’s and receiving singing interventions.

Data sources

Four databases (CINAHL, Medline, PsycINFO, Web of Science) and Google Scholar were searched. The last search was conducted on 3 April 2025.

Primary and secondary outcome measures

Eligible studies reported on the following outcomes: quality of life, voice-related acoustic measures, respiratory function, mental health and motor function. The risk of bias was assessed using the Downs and Black Quality checklist for controlled studies and national heart, lung, blood institute study quality assessment tool for non-controlled studies.

Analysis

Meta-analyses were conducted to pool effect sizes across included studies using random-effects models. All analyses were performed using Meta-Essentials. Additionally, key elements of singing practices were narratively synthesised.

Results

23 studies (3 randomised controlled trials (RCTs), 20 non-RCTs) involving 540 participants were included in the analysis. Common elements of singing intervention practices included breathing exercises, vocal warm-ups and singing participants’ preferred songs, which are largely led by music therapists.Three meta-analyses based on RCTs were conducted on clinical outcome measures; results suggest that singing was favoured in only one outcome measure, vocal loudness during sustained vowel production (standard mean difference (SMD)=0.67, 95% CI 0.29 to 1.05, I2=0%). However, the certainty of this evidence is very low due to a high risk of bias, imprecision and indirectness. Further, when combining results from RCTs and non-RCTs, positive changes for three further outcome measures were observed: maximum phonation time (k=11, n=157, SMD=0.38, 95% CI 0.18 to 0.59, I2=23.48%), vocal loudness of sustained vowel (k=8, n=99, SMD=0.50, 95% CI 0.14 to 0.86, I2=50.96%) and a respiratory function measure of maximal inspiration pressure (k=4, n=65, SMD=0.46, 95% CI 0.07 to 0.85, I2=0%). However, these findings are largely based on non-controlled studies with very low quality of evidence.

Conclusions

Singing interventions may support people living with Parkinson’s, but due to insufficient high-quality evidence, we are unable to determine the effects of singing interventions. We discuss implications for future work and practice, emphasising that more robust RCTs are needed.

Mixed-methods longitudinal evaluation of the mental health first aid (MHFA) for freshman university students in Hong Kong: a study protocol

Por: Capio · C. M. · Kwok · M. K. · Liu · T. W. · Wong · W. K. · Wong · J. Y.-H.
Introduction

The mental health first aid (MHFA) training is an evidence-based programme that is known to improve undergraduate students’ attitudes towards mental illness and confidence in helping people with mental health problems. MHFA training will be implemented at a university in Hong Kong to address growing concerns about mental health challenges among students. Given the context of a university-wide systematic MHFA training implementation, this evaluation uses an intervention logic framework to evaluate the processes and longitudinal outcomes.

Methods and analysis

A mixed-method approach will be used where the quantitative component will gather data from a review of records and a case-control study for outcome evaluation; the qualitative component will gather data from individual interviews. All first-year students from the university in the academic year 2024–2025 (ie, September 2024 to August 2025) will be enrolled in the mandatory MHFA training. The outcome evaluation will assess effectiveness through short-, intermediate- and long-term outcomes. An online questionnaire will be distributed to the students before (pre) and immediately after (post) the MHFA training. For comparison, second-year students who had not participated in MHFA training will be invited to complete the same online questionnaire. The questionnaires will be administered further to those who completed the MHFA training at 12 months (ie, academic year 2025–2026) and 24 months (ie, academic year 2026–2027) post-training to evaluate intermediate-term and long-term effects, respectively. The process evaluation explores feasibility, fidelity, adoption and the barriers and enablers to implementation.

Ethics and dissemination

This evaluation has been approved by the Human Research Ethics Committee of Hong Kong Metropolitan University (reference number HE-SF2024/35). The findings are expected to contribute to establishing long-term effects on mental health literacy and on the actual mental health support actions provided by participants, which goes beyond the intention to help. This evaluation would also facilitate a better understanding of the processes that need to be considered in a systematic MHFA training implementation in a university context. The findings will be disseminated in academic and public health community settings.

Data statement and project registration

This project has been registered in the Open Science Framework. Fully anonymised data will be saved and subsequently made available through the following OSF registration: https://doi.org/10.17605/OSF.IO/92N5Q.

Head-to-head comparison of the RMI and ADNEX models to estimate the risk of ovarian malignancy: a systematic review and meta-analysis of external validation studies

Por: Barrenada · L. · Ledger · A. · Kotlarz · A. · Dhiman · P. · Collins · G. S. · Wynants · L. · Verbakel · J. Y. J. · Valentin · L. · Timmerman · D. · Van Calster · B.
Objectives

Assessment of Different NEoplasias in the adneXa (ADNEX) and Risk of Malignancy Index (RMI) are models that estimate the risk of malignancy in ovarian masses based on clinical and ultrasound information. The aim is to perform a meta-analysis of studies that compared the performance of the two models in the same patients (‘head-to-head comparison’).

Design

Systematic review and meta-analysis.

Data sources

Systematic literature search from publication of ADNEX model (15/10/2014) up to 31/07/2024 in Embase, Web of Science, Scopus, Medline (via PubMed) and EuropePMC.

Eligibility criteria for selecting studies

We included all studies that externally validated the performance of ADNEX (with or without CA125) and RMI on the same data.

Data extraction and synthesis

Two independent reviewers extracted data using a standardised extraction sheet. We assessed risk of bias using PROBAST. We performed random effects meta-analysis of the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and clinical utility (net benefit, relative utility and probability of being useful in a hypothetical new centre) at thresholds commonly used clinically (10% risk of malignancy for ADNEX, 200 for RMI).

Results

We included 11 studies comprising 8271 tumours. Most studies were at high risk of bias. The summary AUC to distinguish benign from malignant tumours in operated patients for ADNEX with CA125 was 0.92 (95% CI 0.90 to 0.94) and for RMI it was 0.85 (0.81 to 0.89). Sensitivity and specificity for ADNEX with CA125 were 0.93 (0.90 to 0.96) and 0.77 (0.71 to 0.81) and for RMI, they were 0.61 (0.56 to 0.67) and 0.92 (0.89 to 0.94). The probability of the test being useful in a hypothetical new centre in operated patients was 96% for ADNEX with CA125 and 15% for RMI at the selected thresholds.

Conclusions

ADNEX has better discrimination and clinical utility than RMI.

Risk and resilience factors associated with the progression of influenza to severe disease outcomes: umbrella review protocol

Por: Park · J. Y. · Dowell · A. · Turner · N. · Albrecht · S. · Hills · I. · Marsh · S.
Introduction

Influenza is a major global health concern, responsible for up to 650 000 respiratory-related deaths annually. Although influenza is often perceived as mild in healthy adults, it can cause severe outcomes in high-risk groups, such as older adults, young children, pregnant women and those with underlying medical conditions. Various clinical, sociodemographic and environmental factors influence the progression to severe outcomes, whereas resilience factors, such as vaccination, may reduce risks. Despite growing research, the evidence base regarding risk and resilience is spread across many different aspects of the literature. This umbrella review will synthesise evidence from existing systematic reviews and meta-analyses to identify key risk and resilience factors associated with the progression of influenza to severe outcomes in the general population.

Methods and analysis

This umbrella review follows the Joanna Briggs Institute (JBI) and Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will include systematic reviews and meta-analyses reporting host-related risk or resilience factors for severe influenza outcomes. Four databases (EMBASE, Scopus, Medline and CINAHL) will be searched for English-language publications. Study quality will be assessed using AMSTAR 2, and the body of evidence will be evaluated using Grading of Recommendations Assessment, Development and Evaluation. Due to heterogeneity, findings will be analysed narratively. Risk and resilience factors will be grouped into demographic, clinical, behavioural, social and psychological domains.

Ethics and disseminations

No ethical approval is required. The completed review will be shared through peer-reviewed journals and conference presentations.

PROSPERO registration number

CRD420250644475.

Protocol for a double-blinded randomised controlled trial and process evaluation of a digital psychotherapeutic app in Singapore to improve symptom burden in patients with dermatological problems

Por: Choi · E. · Long · V. · Phan · P. · Shen · L. · Lim · Z. V. · Koh · M. J.-A. · Chua · J. Y. · Dalakoti · M. · Ho · C. S. · Chandran · N. S. · Sevdalis · N. · Valderas · J. M. · Hsu · K. J.
Introduction

Chronic inflammatory skin diseases, despite low mortality, significantly impair quality of life (QoL). Up to 80% of patients with dermatological conditions experience severe itch and poor sleep, as well as related mental health challenges such as anxiety and depression. The relationship between skin diseases and mental health highlights the challenges that doctors face in treating these conditions. Existing psychotherapeutics, such as mindfulness training, cognitive behavioural therapy and acceptance and commitment therapy, are widely used and effective in the treatment of mental health illnesses. However, there is limited evidence on the application of such interventions in dermatology, and most mental health apps lack robust clinical evaluation. We report the design of a randomised controlled trial to evaluate the efficacy and implementation of a mobile app containing dermatology-specified psychotherapeutic strategies in reducing QoL burden.

Methods and analysis

English-speaking patients aged 16 years and older with psoriasis, eczema or chronic urticaria will be recruited and randomised into the intervention arm (psychotherapeutic application) or active control group (Healthy365 app, a general wellness application managed by the Singapore Health Promotion Board). This allows a comparative assessment of app-usage-specific outcomes while preserving the blinding of all participants. The primary outcome is the change in the Dermatology Life Quality Index (DLQI) score from baseline to week 8. Secondary outcomes include physician-assessed disease severity at weeks 8 and 16 relative to baseline, differences in other patient-reported measures at weeks 8, 16 and 32, self-reported treatment adherence and initiation/escalation of systemic medications. To understand how patients engage with the app, we will evaluate the implementation process, focusing on key measures such as engagement, satisfaction and willingness to pay. Statistical analysis will be carried out on an intention-to-treat basis, and missing data will be analysed using last observation carried forward.

All participants will receive both verbal and written study information that aligns with Good Clinical Practice guidelines. Ethical approval has been obtained from the National Healthcare Group’s Domain Specific Review Board (reference number: 2022/00751). Results will be disseminated via publication in a relevant journal. Data will be available from the corresponding author on reasonable request.

Trial registration number

NCT06702293.

Coproducing a new scale with young people aged 10-24 years: a protocol for the development and validation of the Youth Loneliness Scale (YLS)

Por: Fuhrmann · D. · Riddleston · L. · Verity · L. · Alam · I. · Chavez · L. · Conway · J. · Niaz · A. · Pollmann · A. · Qualter · P. · Spowage · P. · Turner · L. · Walibhai · W. · Lau · J. Y. F.
Introduction

The high prevalence of loneliness in young people, aged 10–24 years, is increasingly recognised as an urgent global health concern. The experience of loneliness is linked to a wide range of adverse physical and mental health outcomes. A lack of loneliness scales that can accurately capture the authentic experiences of young people has hampered progress in our understanding of the aetiology and sequelae of youth loneliness, as well as the development of preventative policies and interventions. Here, we provide a protocol for developing and validating an age-sensitive loneliness scale for young people aged 10–24 years: the Youth Loneliness Scale (YLS). The scale is designed to measure loneliness in the general population of young people in the UK.

Methods and analysis

The scale is coproduced with young people from design to dissemination. The scale development process follows a three-phased, multistep approach that includes item development, scale construction and scale evaluation. Item development is achieved via deductive (literature review) and inductive methods (arts workshops and focus groups), as well as a Delphi survey of experts (by profession and experience) for initial refinement. The scale is then constructed via pretesting items in cognitive interviews with young people, and exploratory testing for preliminary evaluation and refinement. Finally, the scale is administered in confirmatory testing, where a full psychometric evaluation is provided.

Ethics and dissemination

The project was approved by the Queen Mary University of London Research Ethics Committee (Reference: 2024-0231-341) as the lead site and subsequently endorsed by the University of Manchester Research Ethics Committee. The YLS scale and results of its psychometric evaluation will be published open-access. The protocol provided here will allow researchers to evaluate the final scale generated against the plans set out. We also encourage the use and adaptation of the protocol to develop age-sensitive loneliness scales for other populations.

Theory-based chatbot for promoting colorectal cancer screening in a community setting in Hong Kong: study protocol of a randomised controlled trial

Por: Hu · Y. · Lau · W. M. · Wang · Z. J. · Tang · R. S. Y. · Wu · X. · Mo · P. K. H. · Wong · S. Y. S. · Meng · M. L. H. · Dong · D. · Sung · J. J. Y. · Lam · T. Y. T.
Background

Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer mortality worldwide. Despite the organised CRC screening programme, the uptake rate of the population-based CRC screening was still low. Thus, we will conduct a randomised controlled trial in a community setting to evaluate the effectiveness of a theory-based chatbot in promoting CRC screening uptake.

Methods and analysis

A total of 500 eligible participants will be randomly assigned to a WhatsApp Messenger-initiated chatbot outreach group or a standard text reminder group at a ratio of 1:1. The intervention group will deliver Chinese culturally tailored education texts and videos developed based on the Health Belief Model and the Trans-Theoretical Model. The control group will deliver a standard text reminder of information about the Hong Kong organised CRC screening programme. In addition to the baseline assessment and postintervention assessment, all subjects will be followed up for 3 months and 6 months, respectively. The primary outcome will be the CRC screening uptake rate at the 3 month and 6 month follow-up. The secondary outcomes will be the intention to undergo CRC screening uptake, time interval to participate in and complete screening after recruitment, and reasons for not participating in screening at the 3 month and 6 month follow-up. Quantitative data will be analysed using Student’s t-test, Pearson’s 2 test or Fisher’s exact test. Qualitative data will be analysed by thematic analysis.

Ethics and dissemination

Ethical approval of this trial was granted by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (2022.614). Written informed consent will be obtained from study participants before enrolment. The findings will be disseminated through peer-reviewed journals.

Trial registration number

The study was registered on clinicaltrials.gov (NCT06192862).

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