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

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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ProVag: the effect of oral probiotics on the vaginal microbiota composition in women receiving medical assisted reproduction in a Dutch fertility clinic – protocol of a randomised, placebo-controlled, double-blind study

Introduction
Differences in the profile of the vaginal microbiota (VMB) have been associated with pregnancy rates after medical assisted reproduction (MAR) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Monitoring the VMB profile of IVF patients creates an opportunity to identify the best window for IVF treatment and embryo transfer. The ReceptIVFity test is a predictive test that assesses the chances of becoming pregnant in women undergoing IVF treatment based on the VMB composition. A VMB profile dominated by beneficial strains, most notably Lactobacillus species, is associated with increased pregnancy chances. However, to date, limited evidence is available on the effect of active modification strategies to facilitate the modulation of the VMB profile to help restore a VMB dominated by Lactobacillus species.

Methods and analysis
This is a randomised, placebo-controlled, double-blind intervention study. The study will involve 1:1 randomisation to one of the two arms: oral probiotic or placebo. Vaginal and rectal swabs will be collected at intake and 4, 6 and 8 weeks after the start of the treatment. Our objective is to determine if oral probiotic treatment improves the VMB profile of IVF patients from a low to a medium/high ReceptIVFity score, compared with placebo treatment. Secondary outcomes are: the potential of the bacterial strains in the oral probiotic to be detected in the vaginal tract and/or in the gut, and if the treatment leads to an increased ongoing pregnancy rate after IVF.

Ethics and dissemination
Ethical approval was obtained by the local medical ethical review committee at the Maastricht University Medical Centre. Findings from this study will be published in a peer-reviewed scientific journal and presented at one or more scientific conferences.

Trial registration number
CCMO NL81210.068.22, registered 25 September 2023.

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Volumetric choice experiment to estimate the impact of e-cigarette and heated tobacco product characteristics on substitution and complementary use among adults who smoke cigarettes and recently initiated e-cigarette use

Background
This study addresses the limited evidence of the impact of product characteristics on demand for and the substitutability of electronic cigarettes (e-cigarettes) or heated tobacco products for combusted cigarettes among people who smoke and have newly begun to use e-cigarettes.

Methods
A sample of 318 adults who smoke and recently initiated/reinitiated e-cigarette use participated in an online volumetric choice experiment in 2020–2021 to assess stated preferences for consumption and own and cross-price elasticities of three e-cigarette options (cig-a-like, vape pen or tank, closed pod system), heated tobacco product (IQOS) and their usual brand of cigarettes. Product attributes manipulated were price, flavour, level of harm, how well the product reduces cravings to smoke, and how discretely the product can be used. Multilevel zero-inflated negative binomial models were used to model the purchased quantities.

Results
Cigarettes were preferred over all alternatives. However, demand for cig-a-likes, but not IQOS, increased when cigarette prices were higher. Higher prices for e-cigarettes and IQOS did not increase demand for cigarettes. The odds of buying e-cigarettes/IQOS were higher when their harm was stated as low or unknown versus being similar to cigarettes (ie, very high). Other attributes (including various flavour options) were not significantly associated with demand for e-cigarettes or IQOS.

Conclusions
People who smoke and recently began using e-cigarettes might substitute cig-a-likes for cigarettes when cigarette prices are higher. Policies to increase the cost of combusted cigarettes as well as communicate lower relative harm and low absolute harm of e-cigarettes may facilitate switching behaviour.

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Brachial plexus nerve block versus haematoma block for closed reduction of distal radius fracture in adults: The BLOCK Trial – a protocol for a multicentre randomised controlled trial

Introduction
Distal radius fractures account for one-fifth of all fractures in the active elderly population and may cause chronic pain, loss of hand function and reduced work productivity, imposing a significant socioeconomic burden. Most are initially treated with closed reduction and casting, but 30% subsequently require surgery due to insufficient realignment. The current approaches for analgesia for closed reduction are suboptimal. A brachial plexus nerve block provides complete pain relief and muscle relaxation distal to the elbow, potentially creating better conditions for realignment of the fractured bone ends. This may ultimately translate into reduced need for surgery and result in better functional outcomes and fewer complications compared to a haematoma block, which is the current standard care in Denmark.

Methods and analysis
The BLOCK Trial is an investigator-initiated, parallel-group, allocation-concealed, outcome assessor and analyst-blinded, superiority, randomised, controlled, clinical multicentre trial performed at 11 Danish emergency departments. Eligible adult patients with a distal radius fracture who need closed reduction will be included and allocated 1:1 to either an ultrasound-guided brachial plexus nerve block or a haematoma block. The primary outcome is the proportion of patients with distal radius fracture surgery 90 days after closed reduction. We will include 1716 participants to detect or discard a relative risk reduction of surgery of 20%. Secondary outcomes include treatment-related complications, patient-reported wrist function, pain during closed reduction and proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.

Ethics and disseminationf
The trial is approved by the Danish Medicines Agency and the Danish Research Ethics Committees (EU CT number: 2024-512191-35-00). All results will be summarised on www.theblocktrial.com, clinicaltrials.gov and euclinicaltrials.eu after publication. Primary and secondary outcome results from 0 to 90 days will be presented in the main article and submitted to a peer-reviewed journal. Results from outcomes on the 12-month follow-up will be presented separately.

Trial registration number
NCT06678438.

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Association between loneliness and depression, anxiety and anger during the COVID-19 pandemic: a nationwide population-based survey

Objectives
This study aims to determine the association between loneliness and depression, anxiety and anger with a representative sample of the general population in Korea, which are the most prevalent mental health problems during the pandemic.

Design
Cross-sectional study.

Setting
National survey across all 17 provinces in South Korea between December 2021 and January 2022.

Participants
We conducted a national survey on 2699 participants aged 19–84 years using proportional stratified sampling. Using the UCLA Loneliness Scale and standardised questionnaires for depression (Patient Health Questionnaire-9), anxiety (Generalised Anxiety Disorder-7) and anger (Patient-Reported Outcomes Measurement Information System-Anger), we explored the prevalence and association of loneliness with these mental health outcomes.

Primary and secondary outcome measures
Primary outcomes included the prevalence and co-occurrence of depression, anxiety and anger across different levels of loneliness.

Results
Of total, 20.7% and 2.1% experienced moderately high and high levels of loneliness, respectively. Among participants with high levels of loneliness, 11.8%, 5.9% and 11.8% had depression, anxiety and anger, respectively, and 28.7% of them had depression, anxiety and anger together. The adjusted prevalence of depression was 0.2 (95% CI 0.0 to 0.5), 8.2 (95% CI 6.7 to 9.7), 31.3 (95% CI 27.4 to 35.3) and 63.5 (95% CI 50.1 to 76.8) for low, moderate, moderately high and high levels of loneliness, respectively. Similarly, increased adjusted prevalence of anxiety and anger was observed ㅈwith higher levels of loneliness.

Conclusions
Lonely people have a higher risk of depression, anxiety and anger. Identifying individuals who may be vulnerable to loneliness is important for early intervention.

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Analgesia and sedative effects of a fixed nitrous oxide/oxygen mixture on supragingival scaling patients: a study protocol for a randomised controlled trial

Introduction
Pain during supragingival scaling is often uncomfortable for patients, causing varying degrees of fear and anxiety, thus affecting patient comfort and compliance during treatment and reducing the effectiveness of treatment. Nitrous oxide/oxygen mixtures have the advantages of analgesic and sedative effects and are well tolerated. The purpose of this study is to explore the safety and effectiveness of a fixed inhaled nitrous oxide/oxygen mixture analgesia technology in the process of supragingival scaling and to provide empirical evidence for patients to reduce pain and reduce anxiety during supragingival scaling.

Methods and analysis
This is a randomised, double-blind, placebo-controlled trial that is expected to enrol 120 patients. We will recruit patients undergoing supragingival scaling procedures. Participants will be allocated randomly to either the intervention group (A) or the control group (B) in a 1:1 ratio. Dental hygienists, dental assistants, patients and the collector of the data will all blind themselves to the study. Nurses who carry out the intervention will give doctors envelopes containing the patient’s identification code and the group to which they have been assigned (Group A or Group B). Group A will be given the standard treatment plus a premixed combination of nitrous oxide and oxygen, while Group B will receive oxygen alone in the standard treatment without any sedative analgesics, all under uniform conditions. Evaluations will take place prior to treatment (T0), at 5 min into the intervention (T1), at 15 min during the intervention (T2) and 5 min following the treatment (T3). The primary outcomes will be pain scores and anxiety scores, which will be assessed using the Numeric Rating Scale and the Visual Analogue Scale for Anxiety. Secondary outcome indicators in this study will include patients’ vital signs, side effects and physician and patient satisfaction.

Ethics and dissemination
This study was approved by the Medical Ethics Committee of the 960th Logistics Support Force of the People’s Liberation Army. Written informed consent form will be obtained from each participant. Results will be submitted for publication in peer-reviewed journals.

Trial registration number
ChiCTR2400090261.

Protocol version
Protocol version 1.1.

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Randomised controlled trial comparing low doses of aspirin in the prevention of pre-eclampsia (ASAPP): a study protocol

Introduction
Pre-eclampsia (PEC) is a morbid and potentially lethal complication of pregnancy and is more common in women with risk factors such as hypertension, diabetes, autoimmune disease, kidney disease or multifetal pregnancies. Low dose aspirin (ASA) is currently the only prophylactic therapy known to decrease PEC in this patient population. However, currently, there is no prospective literature comparing various low-dose ASA formulations in the risk reduction of PEC. In the USA, the currently available low-dose ASA is over-the-counter and found in 81 mg tablets. Therefore, when clinicians initiate low-dose ASA therapy, they may prescribe one or two tablets of 81 mg per day without comparative evidence to guide their decision. Our objective is to prospectively compare pregnant patients on 81 mg vs 162 mg of ASA and determine a possible dose response in the prevention of PEC.

Methods and analysis
We designed a pragmatic phase 3 prospective randomised open label blinded-end point clinical trial with parallel assignment between two groups of pregnant people at high risk for PEC, as defined by the US Preventive Services Task Force and American College of Obstetricians and Gynecologists (ACOG). The primary outcome is the incidence of preterm (

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Quick pathway for patients with high pRobability of dislocatEd hemiarthroplasty or total hip arthroplasty to minimise the time from hospital aDmission to redUCtion of the prosthesis (Q-REDUCE): protocol for a prospective cohort study

Introduction
Patients with total hip arthroplasties and hemiarthroplasties are both subject to hip dislocations. Although the incidence of complications differs, both patient groups suffer immediate high pain and need acute treatment. The purpose of this study is to design a fast-track pathway for patients with a dislocated hip prosthesis primarily to reduce the time from arrival to reduction and the total hospitalisation time. The secondary aim is to investigate whether quicker prosthesis reduction influences subsequent hip function and quality of life, reduces pain experience immediately and in the long term, and increases patient satisfaction.

Methods and analysis
This is a prospective observational cohort study, initiated on 1 December 2024 and continuing for 2 years. During the first year, patients admitted to the University Hospital of Southern Denmark, Esbjerg, will follow the current standard treatment pathway. After 1 December 2025, a newly developed treatment pathway (fast-track) will be adhered to. Based on a sample size calculation, 120 patients will be included. The main clinical outcomes (time to reduction (primary outcome), total hospitalisation) are registered from patient files. The patients are followed up for 1 year to measure patient-reported outcomes.

Ethics and dissemination
The study is conducted as a treatment quality study and is locally approved by the Executive Board at the University Hospital of Southern Denmark. The results will be published in relevant national and/or international journals and presented at relevant congresses.

Trial registration number
NCT06639334.

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Multisectoral coordination during the COVID-19 pandemic: practices, challenges and recommendations for future preparedness–a systematic literature review protocol

Introduction
The COVID-19 pandemic amplified the need for robust multisectoral coordination; yet the specific mechanisms, benefits and challenges of such collaboration particularly in low- and middle-income countries (LMICs) remain poorly synthesised. This review aims to delineate the key elements, benefits, challenges and improvement strategies of multisectoral coordination during COVID-19 and to compare patterns between LMICs and high-income countries (HICs).

Methods and analysis
Eligible studies will include empirical qualitative, quantitative or mixed-methods research published in English between 1 January 2020 and 15 August 2024 that examines formal coordination mechanisms (eg, task forces, public-private partnerships, inter-agency committees) within the context of COVID-19. Searches will be conducted across PubMed, EBSCOhost, Emerald Insight, Google Scholar and selected grey-literature repositories. Citation chaining will be employed to identify additional sources.
Two reviewers will independently screen all records using Covidence, applying pre-piloted eligibility criteria to 5% of citations and proceeding only if inter-rater reliability achieves ≥0.70. Data will be extracted into a Consolidated Framework for Implementation Research (CFIR)-informed template. Qualitative data will be analysed through framework synthesis, structured by the five CFIR domains. Quantitative data will be narratively summarised and, where outcomes are sufficiently similar across at least two studies, synthesised using a fixed-effect model.
Risk of bias will be assessed using Critical Appraisal Skills Programme for qualitative and Risk Of Bias In Non-randomised Studies of Interventions for non-randomised studies. Studies with serious or critical risk will be excluded from pooling. Subgroup analyses (LMIC vs HIC), sensitivity analyses (model and risk) and confidence grading using Confidence in the Evidence from Reviews of Qualitative Research and Grading of Recommendations, Assessment, Development and Evaluations will be conducted.

Ethics and dissemination
No primary data will be collected; thus additional Research Ethics Committee approval is unnecessary. The results will be disseminated via open-access publication, conference presentations and policy briefs for Nairobi County health stakeholders.

PROSPERO registration number
CRD42023466849.

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Evaluating an intervention to promote access to mental healthcare for low language proficient migrants and refugees across Europe (MentalHealth4All): study protocol for a pretest-post-test cross-national survey study

Background
Migrants and refugees with low language proficiency (LLP) in the dominant language of their host country have a higher risk of suffering from certain mental health disorders compared with non-migrant populations. They are also more likely to experience a lack of access to mental healthcare due to language-related and culture-related barriers. As part of the MentalHealth4All project, a digital multilingual communication and information platform was developed to promote access to mental healthcare for LLP migrants and refugees across Europe. This paper describes the study protocol for evaluating the platform in practice, among both health and/or social care providers (HSCPs) and LLP migrants and refugees.

Methods and analysis
We will conduct a pretest–post-test cross-national survey study to evaluate the platform’s effect evaluation (primary objective) and process evaluation (secondary objective). The primary outcomes (measured at T0, T2 and T3) are four dimensions of access to mental healthcare services: availability, approachability, acceptability and appropriateness of mental healthcare. Secondary outcomes (measured at T2) are: actual usage of the platform (ie, tracking data), perceived ease of use, usefulness of content, comprehensibility of information, attractiveness of content and emotional support. Participants will be recruited from nine European countries: Belgium, Germany, Italy, Lithuania, the Netherlands, Poland, Slovakia, Spain and the UK. Using convenience sampling through professional networks/organisations and key figures, we aim to include at least 52 HSCPs (ie, 6–10 per country) and 260 LLP migrants (ie, 30–35 per country). After completing a pretest questionnaire (T0), participants will be requested to use the platform, and HSCPs will participate in an additional personalised training (T1). Next, participants will fill out a post-test questionnaire (T2) and will be requested to participate in a second post-test questionnaire (T3, about 6–8 weeks after T2) to answer additional questions on their experiences through a brief phone interview (T3 is optional for migrants/refugees).

Ethics and dissemination
For all nine countries, the ethical review board of the participating university (hospital) has assessed and approved the protocol. If successful, the MentalHealth4All platform will be made publicly available to help improve access to mental healthcare services, as well as HSCPs’ cultural competencies in delivering such services, for any LLP migrants and refugees across Europe (and beyond). Findings will also be disseminated through peer-reviewed journals and conferences.

Registration details
The ‘MHealth4All project’ was prospectively registered on Open Science Framework, DOI: 10.17605/OSF.IO/U4XSM.

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Longitudinal study of infants born preterm (<33 weeks) or with a very low birth weight in the Ile de France region of France (SEV-IDF programme): cohort profile

Purpose
The SEV-IDF programme aims to track infants born before 33 weeks of gestation, with very low birth weight (VLBW), neonatal encephalopathy or severe birth anomalies and perinatal disease. It employs an open, prospective, multicentric, population-based cohort approach. This report aims to describe the methodology employed to establish and manage the programme, details regarding follow-up procedures, baseline characteristics of the included infants, and highlights new research opportunities emerging from the “Suivi des Enfants Vulnérables d’Ile-de-France” (SEV-IDF) programme.

Participants
The programme aims to (1) detect developmental anomalies early, (2) improve prevention using standardised data, (3) optimise follow-up care and (4) support multidisciplinary research.
Eligible participants are infants alive at discharge from the 59 maternities with a neonatal unit of the Île-de-France (IDF) region (France). A network of 567 trained physicians monitors the children’s development at 4 months, 1 and 2 years of corrected age, and 3, 4, 5, 6 and 7 years of age. Collected data include sociodemographic, pregnancy and neonatal characteristics, and standardised child development scores.

Findings to date
The programme enrolled 21 175 participants between 2016 and 2023, with 16 461 (77.7%) having a gestational age less than 33 weeks, 1916 (9.0%) others having VLBW, 1525 (7.2%) having encephalopathy and 1273 (6.0%) having another severe birth anomaly.

Future plans
The collected data will enable the SEV-IDF scientific committee to describe high-risk infants in the IDF region, design evidence-based campaigns to improve the quality and effectiveness of the follow-up as well as conduct research on developmental anomalies in these high-risk infants. Ongoing research currently focuses on anticipating loss to follow-up and early detection of developmental anomalies.

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Interventions to mitigate drug shortages in public health systems in sub-Saharan Africa: a scoping review protocol

Introduction
Globally, drug shortages affect low-, middle- and high-income countries to different degrees. The challenges associated with drug shortages in health systems, particularly in public health facilities, and the consequent multiple adverse effects on patients and the health systems have led countries to continue to explore and implement different strategies to combat this challenge. Various factors implicated in drug shortages range from manufacturing concerns, demand issues, supply chain disruptions and regulatory issues. The effects of drug shortages in health systems range from poor patient compliance and therapeutic failure to antimicrobial resistance, low morale among healthcare workers and public distrust in government services. Furthermore, the effects of drug shortages in public health facilities include unavailability of drugs to patients, hospitalisation and readmissions, and associated costs that could be avoided, high out-of-pocket expenditures suffered by patients as patients resort to buying drugs from private pharmacies where the prices are usually exorbitant and prohibitive, putting patients at risk of treatment default due to lack of affordability. Successful mitigation strategies deployed to prevent and manage drug shortages in sub-Saharan Africa (SSA) remain unshared despite the potential of these strategies to serve as valuable lessons if the evidence is scientifically synthesised and reported. The scoping review will synthesise evidence to provide policy guidance for better planning of health services and resources, resulting in improved quality of life for citizens, underscoring the importance of functional and responsive health systems.

Methods and analysis
Using the Joanna Briggs Institute (JBI) scoping review methodology, a five-stage review is outlined: (1) determining the research question, (2) search strategy, (3) inclusion criteria, (4) data extraction and (5) analysis and presentation of the results. The literature search will use PubMed, SCOPUS and the Elsevier Science Direct search interfaces, reflecting empirical and grey literature. We will focus on literature published between 2000 and 2025. The study start and end dates are 1 September–30 November 2025. A two-stage screening process will be used to determine the eligibility of articles. All articles will be individually assessed for eligibility by two reviewers, while a third reviewer will resolve any disagreements. The data from eligible articles will be extracted and charted using a standardised form. Extracted data will be analysed using narrative and descriptive analyses.

Ethics and dissemination
Ethical approval is not required for this scoping review as it will use only previously published data. It does not require human participation. The results of this search will be disseminated through academic presentations at conferences and peer-reviewed publications.

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Poetry, Memory, and Medicine

Poetry catalyzes memory, as other poems featured in JAMA have variously demonstrated. It is used directly among patients with dementia in programs such as the Alzheimer’s Poetry Project to reproducibly beneficial effect. “Missing Father” offers another example of the connections between poetry and memory. The poem both describes actual memories while at the same time seeming to spark more of them. The paradoxical double meaning of the title both reports on and grieves for the lost voice of the storyteller father—he is both absent and an actively yearned-for presence—while the first line’s immediacy of “this morning being” ironically unleashes vivid memories, from the sound of his voice “rising/from the worn pages” of a picture book to the uncanny word-picture of the speaker and her twin sister eagerly awaiting his return from work, “pajamas hanging on us/like wilted petunias.” The poem reanimates them all together as they chant the names of the book’s characters, simultaneously recalling both the tenderness of a distant childhood and enacting poetry’s mooted origins in the passing down of community wisdom through incantatory language. Yet even as poetry facilitates such recollection, and helps sustain the more practical, trying search for “nursing homes close and affordable,” ultimately it cannot bring back the long-gone, stricken father; instead, it becomes an act of healing, remembering that brighter time of more bearable loss, “a day when the only problem/was a carrot missing from/Mister McGregor’s garden.”

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