To assess the prevalence of depression or depressive symptoms among engineering students.

Systematic review and meta-analysis of prevalence surveys using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

PubMed, Index Medicus Global, EMBASE, Web of Science, Scopus and PsycINFO were searched from 1 January 2003 to 28 June 2024.

Studies were included if they: (1) reported the prevalence of depression or depressive symptoms among engineering students, (2) used a validated instrument with defined cut-off points to assess depression or depressive symptoms and (3) were published in a peer-reviewed journal.

Two researchers independently extracted data using a standardised spreadsheet, collecting information on country of data collection, survey years, year of training, sample size, mean age of participants, number and percentage of male participants, assessment instrument, cut-off points and prevalence estimates. Discrepancies were resolved by a third researcher. Risk of bias was assessed with the Risk of Bias for Studies of the Prevalence of Mental Health Disorders tool. Prevalence estimates were synthesised using random-effects meta-analysis. Between-study heterogeneity was assessed with ² tests and the I² statistic. Subgroup analyses were conducted according to severity cut-off points, and meta-regression was used to explore the influence of study-level characteristics on prevalence estimates.

23 studies involving 12 758 students across 11 countries were analysed. All studies used validated scales with cut-off points to assess depression or depressive symptoms. The overall pooled prevalence was 42.6% (95% CI 32.7 to 53.1) for studies using symptom severity cut-off points at mild or above, and 33.1% (95% CI 25.2 to 42.0) for studies using symptom severity cut-off points at moderate or above. Meta-regression indicated a progressive annual increase in prevalence (OR 1.14, 95% CI 1.01 to 1.28, p=0.034) across studies conducted from 2014 to 2024.

Prevalence of depression and depressive symptoms is high among engineering students, at levels comparable to medical students. Given the substantial impact, further research should investigate risk factors and evaluate preventive, early detection and treatment strategies tailored to engineering students.

CRD42024571131.

Mistreatment and obstetric violence constitute significant human rights violations with profound implications for maternal mental health. These detrimental practices persist globally, particularly in contexts where underfunded health systems, workforce shortages and entrenched gender inequalities intersect, depriving women of adequate psychosocial support and culturally sensitive mental healthcare. Although awareness of the immediate harms of mistreatment is increasing, its cumulative effects throughout the maternal care continuum remain insufficiently understood. This review will synthesise evidence on the impact of mistreatment on perinatal mental health, identify critical gaps and advocate for systemic change.

This systematic review and meta-analysis protocol complies with the guidelines set forth by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. A thorough literature search will be executed across multiple electronic databases, including CINAHL—Cumulative Index to Nursing and Allied Health Literature, Embase via Ovid, MEDLINE, PsycInfo, PubMed, Scopus, as well as other significant or specialised databases and grey literature. The review will incorporate only non-randomised study types and observational studies (cohort, cross-sectional, case-control), along with mixed-method and qualitative studies. Abstract and full-text screening will be performed by two reviewers using Covidence. The methodological quality of the included studies will be assessed using the Newcastle-Ottawa Scale for observational studies, the Risk of Bias in Non-Randomised Studies of Interventions, the Critical Appraisal Skills Programme and the Mixed Methods Appraisal Tool. Statistical heterogeneity will be evaluated using the Higgins test. Meta-analysis will be conducted using R statistical software V.4.4.4, employing random effects models to determine the weights. The study results will be reported sequentially, beginning with primary outcomes, followed by secondary outcomes and significant subgroup outcome analyses.

Ethical approval is not required as no original data will be collected. The findings of this review will be disseminated through publication and conference presentations.

CRD420251044379.

This study aimed to assess the prevalence of eye care service utilisation and associated factors among healthcare professionals in Gondar city, northwest Ethiopia.

An institution-based cross-sectional study was conducted using a systematic random sampling method.

The study was conducted at public healthcare facilities in Gondar city, orthwest Ethiopia.

The study included 607 healthcare professionals who worked in public healthcare facilities in Gondar ity.

Data were collected using personal interview using a pretested and structured questionnaire.

A total of 607 study participants took part in this study with a response rate of 91.97%. The median age of the participants was 32 years (IQR 30–36; range ±6). The proportion of eye care services utilisation in this study was 27.68% (95% CI 24.11% to 31.25%). Being masters or higher degree educational status (adjusted OR (AOR)=4.81, 95% CI: 2.01, 11.46), having more than ten years of working experience in healthcare (AOR3.01, 95% CI: 1.51 to 5.99), being affiliated with general hospital (AOR 4.02, 95% CI 1.51 to 10.68) and specialised hospital (AOR 3.02, 95% CI 1.55 to 5.89), obtaining prior eye healthcare training (AOR 1.90, 95% CI 1.20 to 3.00) and having a higher monthly household income (AOR 3.59, 95% CI 1.89 to 6.81) were positively associated with eye care service utilisation.

This study revealed that the proportion of eye care service utilisation among study participants was low. Holding a master or higher degree, more than 10 years of working experience in healthcare, affiliation with general or specialised healthcare facility, obtaining prior eye healthcare training and higher monthly household income were significantly associated with a good level of eye care service utilisation.

Penicillin allergy is a significant barrier to optimal antibiotic stewardship, contributing to increased antimicrobial resistance, higher treatment costs, prolonged hospital stays and elevated mortality rates. However, approximately 90% of penicillin allergy labels are disproven on evaluation. Risk stratification-based penicillin allergy evaluation (PAE) has proven safe and effective outside allergology departments, yet its adoption in routine clinical practice remains limited. This study aims to examine the implementation of a risk stratification-based PAE programme across hospitals in Western Norway.

We aim to examine implementation of a risk stratification-based programme for evaluating and de-labelling declared penicillin allergy in Western Norway hospitals in a multicentre study. The study employs a combined stepped wedge- and interrupted time series design. It includes hospitals of varying service levels in both urban and rural settings. Each participating centre receives 12 months of active implementation support, followed by a 6 month postintervention evaluation. The study is guided by the Consolidated Framework for Implementation Research and the Expert Recommendations for Implementing Change. Implementation outcomes assessed include acceptability, fidelity, adoption, penetration, feasibility and sustainability.

The study was approved by the Regional Ethics Committee of Western Norway (approval number: 199210). All legal and formal research requirements are met. Results will be published open access in peer-reviewed journals and included in the first author’s publicly available PhD. Nationwide implementation of PAE is planned, informed by the study’s findings.

Current Research Information System (Cristin) in Norway project identification number: 2500736.

To evaluate the impact of video use in out-of-hours primary care (OOH-PC) telephone triage by examining how triage outcomes (ie, ended by telephone, clinic consultation or home visit) changed during a period with video service failure.

Observational register-based study, using periods of video service failure as a randomisation mechanism for a controlled study.

OOH-PC in four of the five Danish regions.

All telephone triage contacts to the OOH-PC call centres between April 2020 and December 2021.

Video service failures resulted in a subset of telephone triage contacts without the option of using video as a triage tool. Video service failures were identified algorithmically based on observed periods without video use.

Proportion of telephone triage contacts with clinic consultations or home visits as triage outcome during a period of video service failure compared with matched reference telephone triage contacts taking place during normal service (1:10), presented as risk ratios (RR) with 95% CI).

The algorithm identified 6605 telephone triage contacts during video service failure. Compared with matched contacts during normal service, these had a 15% higher risk of resulting in a clinic consultation (RR: 1.15, 95% CI 1.09 to 1.20). This effect was primarily isolated to the year 2021 (RR: 1.23, 95% CI 1.16 to 1.31) compared with 2020 (RR: 1.05%, 95% CI 0.97 to 1.13). Video service failure did not significantly affect the risk of a home visit.

Results strongly suggest that the unavailability of the video service is likely to significantly increase the number of clinic consultations in OOH-PC as a triage outcome. Whether this effect is likely to persist in the long term remains unclear.

Despite efforts to improve feeding practices globally, 48% of children do not meet the recommended minimum meal frequency. Thus, the aim of this study was to assess minimum meal frequency and its associated factors in children aged 6–23 months in cash crop districts of Kercha, Southern Ethiopia.

A community-based cross-sectional design was used to conduct this study from 29 February 2024 to 29 March 2024.

Kercha district, Southern Ethiopia

A total of 543 children aged 6–23 months were selected using a multistage sampling technique.

The primary outcome of this study was minimum meal frequency, defined as the percentage of children aged 6–23 months who consumed solid, semisolid or soft foods (including milk for non-breastfed children) at least the required number of times for their age in the previous day.

The secondary outcome of this study was factors associated with minimum meal frequency. Bivariable and multivariable multilevel mixed-effect logistic regression analyses were performed to find factors related to minimum meal frequency. Adjusted ORs (AORs) with 95% CIs and p values

A total of 539 (99.3%) children aged 6–23 months and their mothers participated in this study. The prevalence of minimum meal frequency was 62.3% (95% CI 58.1% to 66.4%) among children in the cash crop district of Kercha. The final model yielded an intracluster correlation coefficient of 7.3%, reflecting unexplained variations in the prevalence of minimum meal frequency among children at the kebele level. Factors associated with higher odds of meeting minimum meal frequency included being a first-born child (AOR 2.91, 95% CI 1.06 to 8.05), mothers (AOR 2.66, 95% CI 1.48 to 4.76) and fathers (AOR 3.43, 95% CI 1.98 to 5.95) with primary education, having mother attending postnatal visits (AOR 2.74, 95% CI 1.52 to 4.94), introducing additional food at 6 months (AOR 4.71, 95% CI 2.79 to 7.94), good maternal knowledge on child feeding (AOR 1.98, 95% CI 1.21 to 3.22) and living in the household with medium (AOR 2.98, 95% CI 1.59 to 5.53) and rich (AOR 2.39, 95% CI 1.37 to 4.18) wealth status.

The study revealed that only three-fifths of children met the recommended minimum meal frequency. Birth order, introducing additional foods at 6 months, parental education, maternal postnatal visits, good maternal knowledge on child feeding and wealth were linked to minimum meal frequency. To improve child nutrition, it is crucial to enhance maternal education, increase access to postnatal healthcare and educate parents about the importance of introducing additional foods at 6 months.

Inappropriate medication use among surgical patients poses significant risks, including antibiotic resistance, complications, mortality, increased healthcare costs and challenges in pain management. This study aimed to assess the extent of inappropriate antibiotic and analgesic prescriptions, treatment adequacy and contributing factors.

A hospital-based cross-sectional study was conducted among patients admitted to surgical wards in three comprehensive specialised hospitals in northwest Ethiopia.

All eligible adult patients admitted to the surgical wards during the data collection period were included in the study.

The primary outcomes were the appropriateness of antibiotic and analgesic prescriptions. To assess patients’ pain perception and the effectiveness of pain management strategies, the American Pain Society Patient Outcome Questionnaire was used. The Pain Management Index was employed to evaluate the treatment adequacy. The RAND (Research and Development)-modified Delphi method was applied to reach expert consensus on best practices for antibiotic prescribing. Additionally, the national standard treatment guideline was used to benchmark prescribing practices. Binary logistic regression was used to identify factors associated with inappropriate prescriptions of antibiotics and analgesics.

The prevalence of inappropriate antibiotics use was 67.5% and 42.2% of patients received inappropriate analgesic prescriptions. Moreover, 51.6% of patients experienced inadequate pain management. Significant factors associated with inappropriate antibiotic prescription included the presence of comorbidities (adjsuted OR (AOR) 3.34, 95% CI 1.88 to 5.92), lack of laboratory tests (AOR 0.26, 95% CI 0.16 to 0.43, higher number of medications (AOR 2.71, 95% CI 1.62 to 4.52) and contaminated wound class (AOR 3.13, 95% CI 1.58 to 6.20). For inappropriate analgesic prescription, pain due to disease (AOR 8.69, 95% CI 1.73 to 4.62), mixed causes of pain (AOR 7.20, 95% CI 1.43 to 6.31), head and facial pain (AOR 0.14, 95% CI 0.05 to 0.39) and an increased number of medications (AOR 2.75, 95% CI 1.72 to 4.41) were significant factors.

The majority of the patients admitted to surgical wards were found to receive inappropriate antibiotic and analgesic medications. Prescribers should pay attention to patients with comorbid diseases, receiving multiple medications. Additionally, routine laboratory tests are essential for guiding antibiotic therapy and improving patient outcomes in surgical wards.

A substantial number of patients with major depressive disorder experience non-remission despite treatment with psychotherapy and several antidepressant drugs. This has increased the interest in new treatment strategies, including non-invasive brain stimulation methods. This randomised controlled trial examines a new treatment method using transcranial-pulsed electromagnetic fields (T-PEMF) delivered via a MoodHeadBand (MHB). The main study objective is to examine the antidepressant effect of T-PEMF on moderate to severe depression.

A double-blinded, randomised (1:1), sham-controlled trial with 96 participants diagnosed with moderate to severe depression without psychotic symptoms, recruited from Psychiatric Center Copenhagen. Participants receive daily 30 min at-home T-PEMF or sham treatment for 8 weeks with the MHB. Depressive symptomatology is examined using the Inventory of Depressive Symptomatology (Self-Report) (primary outcome) and Hamilton-D-17 Items Rating Scale at baseline and treatment completion. Cognitive functions are examined using a battery of emotion-laden and non-emotion-laden tests at baseline, after 1 week and at treatment completion. The participants fill out the Quick Inventory of Depressive Symptomatology (Self-Report) and sleep logs weekly. Summary statistics, generalised linear models, proc mixed models, mixed model repeated measures and Kaplan-Meier analysis will be applied as appropriate to analyse data on depressive symptoms, cognition and sleep.

The Danish Medicines Agency (CIV-23-01-041987) and the Medical Research Ethics Committee (2215332) have approved the trial. The project concurs with the EU directive for medical devices 2017/745 of 5 April 2017 and the ISO 14155 standard. Participants give written informed consent before any trial-related activities. Results will be published in peer-reviewed journals and presented at relevant conferences.

NCT06005103.

The introduction of fentanyl and its analogues in the illicit drug supply has prompted greater emphasis on refining clinical treatment protocols to ensure sustained retention in opioid agonist treatment (OAT). Take-home dosing may lessen the treatment burden on clients and thus reduce the risk of treatment discontinuation. The evidence base supporting the use of take-home dosing, including the optimal duration of dispensations, is, however, limited. The objective of this study is to determine the comparative effectiveness of alternative take-home dosing schedules, as observed in clinical practice in British Columbia, Canada from 2010 to 2022.

We propose to emulate a target trial with a population-level retrospective study of individuals initiating methadone or buprenorphine/naloxone between 1 January 2010 and 31 December 2022 who are 18 years of age or older and not currently incarcerated or pregnant with no history of cancer or palliative care. Our study will draw on nine linked health administrative databases from British Columbia and will evaluate take-home doses of 2–5 days, 6 days or >6 days compared with continuous daily dosing. The primary outcomes include OAT discontinuation and all-cause mortality on treatment. A causal per-protocol analysis is proposed with longitudinal matching and inverse probability of censoring weighting approaches to adjust for time-fixed and time-varying confounding. A range of sensitivity analyses will be executed to determine the robustness of results.

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated and shared with local advocacy groups and decision-makers, developers of national and international clinical guidelines, presented at national and international conferences and published in peer-reviewed journals electronically and in print.

Total diet replacements (TDRs) and weight loss medications (WLMs) have proven effective in producing substantial weight loss for individuals with obesity. Evidence is lacking on whether combining these treatments is effective and cost-effective in primary care for adults with obesity class I (body mass index (BMI) 30–34.9) or uncomplicated obesity class II or higher (BMI≥35 without obesity-related disease).

LightCARE is a 2-year 1:1 randomised, parallel-group, clinical superiority trial with blinded outcome assessment evaluating the benefits and harms of an intensive weight loss (IWL) intervention compared with usual care for adults with obesity in Denmark and the UK. The trial will include 400 participants aged 18–60 years with obesity class I or uncomplicated obesity class II or higher. The IWL programme aims to achieve and maintain a weight loss of ≥20% through a flexible and individualised combination of TDR, behavioural support, including physical activity and sleep guidance, and WLM if needed and will continue for 2 years. The control group will receive usual care offered in each country, typically consisting of brief behavioural support for weight loss. The primary outcome is body weight 2 years after randomisation. Secondary outcomes will include the proportion of participants achieving ≥20% weight loss, Short-Form-36 Mental Component Score, 4-m gait speed and Metabolic Syndrome Severity-Z score. Serious adverse events, the incidence of eating disorders and bone mineral density will be evaluated as safety outcomes. We will also examine the cost-effectiveness of the intervention, within the trial and in the longer term through modelling. We will conduct a process evaluation to inform any future implementation.

Ethical approval was granted in Denmark (December 2023, H-23051332) and the UK (August 2024, 24/SC/0210). Findings from the trial will be disseminated through peer-reviewed journals and scientific conferences.

NCT06321432.

A scoping review on the association between ID and frailty was published in 2016,1 which found that frailty may affect people with ID at a young age and is associated with negative outcomes. The authors of the paper discussed here sought to update the...

Diabetic retinopathy (DR) in pregnancy can cause blindness. National guidelines recommend at least one eye examination in early pregnancy, then ideally 3-monthly, through to the postpartum for pregnant women with pregestational diabetes. Here we examined adherence rates, barriers and enablers to recommended DR screening guidelines.

Cross-sectional survey study, as part of a larger prospective cohort study.

Participants were recruited from two tertiary maternity hospitals in Melbourne, Australia.

Of the 173 pregnant women with type 1 (T1D) or type 2 diabetes (T2D) in the main cohort study, with an additional four who participated solely in this survey study, 130 (74.3%) completed the survey.

This study calculated rates of adherence to guideline-recommended DR screening schedules and collected data on the enablers and barriers to attendance using a modified Compliance with Annual Diabetic Eye Exams Survey. Each of the 5-point Likert-scale survey items was compared between adherent and non-adherent participants using the Wilcoxon rank-sum test and logistic regression models were constructed to quantify associations as ORs.

A retinal assessment was undertaken at least once during pregnancy in 86.3% of participants, but only 40.9% attended during their first trimester and only 21.2% attended the recommended number of examinations. Competing priorities were the main barriers to adherence, with eye examinations ranked as the fourth priority (IQR 4th–5th) among other health appointments during pregnancy. Meanwhile, knowledge of the benefits of eye screening examinations, eye-check reminders and support from relatives was identified as enablers.

Despite the risk of worsening DR during pregnancy, less than half of the participants adhered to recommended screening guidelines, suggesting that eye health is not a priority. Proactive measures to integrate care are needed to prevent visual loss in this growing population.

The Puerto Rico Department of Health (PRDH) seeks to identify dengue epidemics as early as possible with high specificity.

Development and prospective application of an early warning system for dengue epidemics using routine historical surveillance data. A weekly intercept-only negative binomial regression model was fitted using historical probable and confirmed dengue data. A range of threshold definitions was explored using three model-estimated percentiles of weekly dengue case counts.

Dengue is endemic in Puerto Rico with irregular occurrence of large epidemics with substantial impact on health burden and health systems. Probable and confirmed dengue data are routinely collected from all hospitals and private clinics.

A total of 86 282 confirmed or probable dengue virus cases were reported from 1 January 1986 to 30 June 2024, with an annual mean of 2212 cases (median: 1533; range: 40–10 356).

The model was fitted retrospectively to mimic real-time epidemic detection and assessed based on sensitivity and specificity of epidemic detection.

The 75th percentile threshold aligned best with historical epidemic classifications, balancing false alarms and missed detections. This model provides a robust method for defining thresholds, accounting for skewed data, using all historical data and improving on traditional methods like endemic channels.

In March 2024, PRDH declared a public health emergency due to an early, out-of-season surge in cases that exceeded the epidemic alert threshold developed in this study. This real-time application highlights the value of these thresholds to support dengue epidemic detection and public health response. Integrating thresholds with other tools and strategies can enhance epidemic preparedness and management.

Despite low sensitivity and implementation challenges, the tuberculin skin test (TST) remains the standard-of-care tuberculosis (TB) infection test in Mexico. Interferon gamma release assays (IGRA) may overcome TST-related challenges. Within the confines of the local programmatic setting, this cross-sectional study evaluated the prevalence of TB infection (TBI) and concordance of TST and IGRA in three high-risk populations in Mexicali, Baja California, Mexico.

Household contacts (HHC) of individuals with TB, people who use drugs (PWUD), people deprived of liberty (PDL) and prison employees underwent evaluation for TBI using TST and QIAreach, a novel IGRA. Prevalence of infection, concordance of test results and reactivity trends of time-to-results (TTR) by TST-induration size were assessed.

In total, 214 of 411 (52.07%) people who had TST and 269 of 460 (58.48%) people who had IGRA tested positive for TBI. Frequency of infection varied across risk groups (HHC 29 (29.6%); PWUD 67 (70.53%); PDL 111 (56.06%) and prison employees 7 (35.0%), p20 mm, p=0.05).

All risk groups had a high frequency of TBI, necessitating locally tailored guidelines for screening, treatment and management of TBI to optimise care for vulnerable populations.

Medical oxygen supplementation is essential for treating severe illnesses and plays a critical role in managing life-threatening conditions, especially during the period of increased demand, such as the delta wave of COVID-19. The study aims to evaluate oxygen requirements and production to support effective capacity planning for future health crises.

Cross-sectional quantitative study. Data collection was carried out between 15 March and 19 December 2021.

The study used secondary data from Nepal’s Health Emergency Operation Centre. Regarding medical oxygen production, calculations included oxygen generated from both hospital-based oxygen plants and private companies, using their highest capacities for comparison. These production capacities were then assessed using three levels of efficiency (100%, 80% and 50%), revealing significant gaps when compared against the oxygen requirements of hospitalised COVID-19 patients, as guided by WHO recommendations. The results were communicated in terms of J-size cylinders, alongside average daily COVID-19 hospitalizations. Data was inputted and analysed using Microsoft Excel and presented in numbers and percentage.

The country’s oxygen demand relies largely on the production from private enterprises, with meeting approximately 85.2% of the total requirement. Optimal production ensures that national oxygen needs will be met. The analysis highlighted that at 80% operational efficiency, 90.8% of the hospital’s requirements could be fulfilled. However, if operational efficiency drops to 50%, the fulfilment rate diminishes to 56.7%. The differences in requirement and production of oxygen are consistent across the provinces; however, a huge disparity was notable in Karnali and Sudurpaschim.

Continuous assessment of production capacities in both hospital and private enterprises producing oxygen is necessary to plan and address the gaps.

Lateral hip pain due to hip abductor tendon pathology (ie, gluteal tendinopathy or tendon rupture) is a relatively new diagnosis. This patient group has previously been described as a clinical dilemma due to the often-short-lived effects of treatment. In the process of identifying the underlying pathology, however, more targeted treatment strategies have been explored. Recent research recommends exercise as a first-line treatment for this patient group along with patient education. However, patients seen in a hospital setting (secondary healthcare) often present recalcitrant lateral hip pain, tendon ruptures and multiple comorbidities. Whether patient education and exercise therapy are beneficial for patients in secondary healthcare has only been sparsely investigated. Therefore, this study aims to investigate changes in lateral hip pain following a 3 month physiotherapist-led patient education and exercise intervention in patients with MRI-proven hip abductor tendon pathology seen in a hospital setting.

In this prospective cohort trial, 60 patients, presenting lateral hip pain and MRI-verified hip abductor tendon pathology at the orthopaedic outpatient clinic at Horsens Regional Hospital, Denmark, a public teaching hospital, are included. Hip abductor tendon pathology will be diagnosed by clinical tests and MRI. The intervention consists of seven physiotherapist-led patient education and exercise sessions at the hospital during 3 months. The instructions will guide the patients in their daily home-based exercise sessions.

The primary outcome is change in lateral hip pain measured by the ‘pain’ subscale from the patient-reported outcome measure: the revised Copenhagen Hip And Groin Outcome Score (HAGOS). Secondary outcomes are changes in the remaining subscales of the revised HAGOS, Oxford Hip Score, Victorian Institute of Sports Assessment-Gluteal Questionnaire, European Questionnaire-Five Dimensions Five-Level, lateral hip pain (numeric rating scale score, 0–10), hip muscle strength and the 30 s chair stand test. Also, patient-reported Global Rating of Change in hip condition, as well as adherence and harms, will be reported.

This trial has been accepted by the Central Denmark Regions Ethics Committee (1-10-72-136-22). The study is registered at the Central Denmark Region List of Research Projects (Journal No 1-16-02-180-24) and clinicaltrials.gov (NCT06418217).

All results from this study, regardless of the direction, will be published in a peer-reviewed journal and presented at national and international congresses.

NCT06418217.

Continuous glucose monitoring (CGM) provides real-time glucose data for people with diabetes. However, detailed knowledge of its use in daily life remains limited. We aim to investigate the interaction between people with type 1 diabetes (T1D) and their CGM data and the impact of the interaction on glycaemia and diabetes distress.

This is a two-centre observational study of adults (n=500) with T1D using FreeStyle Libre 2. Over a period of 14 days, participants will continue their regular CGM use, record insulin doses and timing with smart insulin pens, track activity and sleep with an activity tracker, log all food intake in the LibreLink app and answer questions about quality of life and hypoglycaemia two times per day. Before the study period, the participants will complete a survey of 11 validated questionnaires assessing diabetes distress, hypoglycaemia awareness and other patient-reported outcomes (PROs). After the study period, the participants will complete two additional questionnaires assessing diabetes distress and health literacy.

The collected data will be used in two substudies with the overall aims of:

Substudy 1: to investigate how CGM is used in practice and the impact of the interaction on diabetes distress and glycaemia.

Substudy 2: to investigate whether and how CGM functions as a technological substitute for impaired awareness of hypoglycaemia, focusing on alarm data.

Endpoints will include CGM metrics, alarm data and PROs.

The Danish Data Protection Agency approved the study (P-2024–15985), and the regional committee on health research ethics has granted an ethical waiver (H-24014662). All participants have signed written informed consent forms before participating. The results will be published in an international peer-reviewed scientific journal by the study investigators and shared via www.clinicaltrials.gov. Participants who agreed to receive information about the study will be sent the results after publication.

ClinicalTrials.gov (NCT06453434).

Selecting an optimal initial dosage of opioid agonist treatment (OAT) balances effectiveness and safety, as initial doses that are too low may be insufficient, potentially prompting clients to seek unregulated drugs to alleviate withdrawal symptoms, which may increase the likelihood of treatment discontinuation. Conversely, initial doses that are too high carry a risk of overdose. As opioid tolerance levels have risen in the fentanyl era, linked population-level data capturing initial doses in the real world provide a valuable opportunity to refine existing guidance on optimal OAT dosing at treatment initiation. Our objective is to determine the comparative effectiveness of alternative initial doses of methadone, buprenorphine-naloxone and slow-release oral morphine at OAT initiation, as observed in clinical practice in British Columbia (BC), Canada.

We propose a population-level retrospective observational study with a linkage of nine provincial health administrative databases in BC, Canada (1 January 2010 to 31 December 2022). Our study includes two time-to-event primary outcomes: OAT discontinuation and all-cause mortality during follow-up. We propose ‘initiator’ target trial analyses for each medication using both propensity score weighting and instrumental variable analyses to compare the effect of different initial OAT doses on the hazard of time-to-OAT discontinuation and all-cause mortality. A range of sensitivity analyses will be used to assess the robustness of the results.

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.

Methadone and buprenorphine/naloxone are effective medications for people with opioid use disorder; however, interruptions in daily dosing are common and diminish the benefits of these medications. While clinical guidelines in most North American jurisdictions, including British Columbia (BC), recommend dose adjustment after treatment interruptions to varying levels of specificity, the evidence to support these recommendations is limited. We aim to estimate the comparative effectiveness of alternative dose adjustment strategies on subsequent overdose-related acute care visits and discontinuation of opioid agonist treatment in BC, Canada.

Using a linkage of nine health administrative databases, we propose a population-level retrospective cohort study of adults aged 18 years or older in BC who initiated methadone or buprenorphine/naloxone between 1 January 2010 and 31 December 2022. We will specify parallel hypothetical trials, known as target trials, for methadone interruptions of 1–3 days, 4 days and 5–14 days, and buprenorphine/naloxone interruptions of 1–5 days and 6–14 days. Following the index interruption, the primary outcomes are the time to overdose-related acute care visits and treatment discontinuation (interruptions lasting >14 days), with time to all-cause acute care visits as a secondary outcome. The intention-to-treat effect will be estimated using both propensity score and instrumental variable approaches. A range of sensitivity analyses will assess the robustness of our results, including cohort and timeline restriction, alternative definitions of exposure and outcome and alternative estimation strategies.

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Institute and the Simon Fraser University Office of Research Ethics. All data are deidentified, securely stored and accessed in accordance with provincial privacy regulations. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.

Conventional cardiotocography (CTG) has been used extensively to monitor the fetal condition during labour. However, conventional non-invasive monitoring is limited by the difficulty of obtaining an adequate signal quality, particularly in the case of obese parturients. Furthermore, the rate of operative deliveries keeps rising despite the ability for conventional intrapartum monitoring. Electrophysiological monitoring is an alternative technique that has been developed over the past decades to improve signal quality. This non-invasive, transabdominal and wireless alternative measures fetal heart rate by fetal electrocardiography (NI-fECG), and uterine activity by electrohysterography (EHG). Both NI-fECG and EHG have been proven to be more accurate and reliable than conventional non-invasive methods and are less affected by maternal Body Mass Index. Nevertheless, it is still unknown whether electrophysiological intrapartum monitoring leads to better obstetric and neonatal outcomes. This study aims to investigate whether electrophysiological monitoring during labour affects the number of operative interventions compared with conventional monitoring during labour.

This is a single-centre cohort intervention random sampling study which will be performed in a tertiary obstetric care centre. In total, 3471 term pregnant women with a singleton fetus in cephalic position and indication for continuous fetal monitoring during labour will be included. Eligible women will be prospectively included in the cohort for conventional monitoring. From these women, 90.9% of women will be randomly sampled and will be offered electrophysiological monitoring. A historical cohort of an additional 2100 women who received conventional monitoring will be added to the conventional group. This historical cohort was collected between April 2019 and February 2023. The primary outcome will be the number of operative interventions during labour. Secondary outcome measures include maternal and neonatal outcomes, patient and healthcare professional perspectives and costs.

This study received approval from the Medical Ethics Committee of Máxima Medical Centre (W22.071) on 1 November 2023. All participants will provide informed consent prior to data collection. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.

NCT06135961.