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Hoy — Octubre 2nd 2025Tus fuentes RSS

Efficacy of a mobile app-based intervention to improve eating behaviours and lifestyle in infants of mothers with metabolic risk factors: study protocol of a randomised controlled trial

Por: Chan · D. · Leong · K. · Ong · C. · Ku · C. W. · Chan · J. K. Y. · Chua · M. C. · Yap · F. · Loy · S. L.
Introduction

Childhood obesity has surged globally, leading to various metabolic comorbidities and increased cardiovascular risks. Early intervention in lifestyle and feeding practices during infancy is crucial to mitigate these risks. This study evaluates the efficacy of a mobile web app-based intervention tool, named the Feeding, Lifestyle, Activity Goals (FLAGs) to promote healthier eating behaviours and lifestyle habits in infants from birth to 12 months.

Methods and analysis

This two-arm randomised controlled trial will enrol 220 caregiver-infant pairs per arm at KK Women’s and Children’s Hospital, Singapore, with recruitment expected from January to December 2025. Eligible participants include women at ≥34 weeks’ gestation or up to 3 days post delivery with pre-pregnancy overweight/obesity (body mass index (BMI) >23 kg/m2) and/or a diagnosis of diabetes. Caregiver-infant pairs will be randomised to the FLAGs intervention or control group. Over 12 months, both groups will receive standard infant care. The intervention group will undergo regular assessments via the FLAGs web app built-in assessment tool, assessing infant feeding practices, sedentary behaviour and physical activity. The intervention group will also receive FLAGs personalised guidance and weekly digital nudges. Maternal and infant data will be collected at baseline and at 12 months. Primary outcomes are infant BMI, weight-for-length and body composition at 12 months. Secondary outcomes include lifestyle behaviours and eating habits assessed through validated questionnaires when the infants are 1 year old. We will perform both intention-to-treat and per protocol analysis.

Ethics and dissemination

Ethical approval has been obtained from the SingHealth Centralised Institutional Review Board (Ref: 2024/3224). Written informed consent will be obtained from all participants. Study findings will be disseminated via peer-reviewed publications and academic conferences, with de-identified data available on reasonable request. This trial is registered on ClinicalTrials.gov (ID: NCT06457750).

Trial registration number

NCT06457750.

Protocol for an observational cohort study integrating real-world data and microsimulation to assess imaging surveillance strategies in stage I-IIIA NSCLC patients in OneFlorida+

Por: Braithwaite · D. · Karanth · S. D. · Bian · J. · Meza · R. · Jeon · J. · Tammemagi · M. · Wheeler · M. · Cao · P. · Rackauskas · M. · Shrestha · P. · Yoon · H.-S. · Borondy Kitts · A. · Verma · H. · Blair · M. C. · Chen · A. · Das · D. · Lou · X. · Wu · Y. · Han · S. · Hochhegger · B. · Guo · Y
Introduction

Although lung cancer remains the leading cause of cancer deaths in the US, recent advances in early detection and treatment have led to improvements in survival. However, there is a considerable risk of recurrence or second primary lung cancer (SPLC) following curative-intent treatment in patients with early-stage non-small cell lung cancer (NSCLC). Professional societies recommend routine surveillance with CT to optimise the detection of potential recurrence and SPLC at a localised stage. However, no definitive evidence demonstrates the effect of imaging surveillance on survival in patients with NSCLC. To close these research gaps, the Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2) study will leverage real-world electronic health records (EHRs) data to evaluate surveillance outcomes among patients with and without guideline-adherent surveillance. The overarching goal of the PLuS2 study is to assess the long-term effectiveness of surveillance strategies in real-world settings.

Methods and analysis

PLuS2 is an observational study designed to assemble a cohort of patients with incident pathologically confirmed stage I/II/IIIA NSCLC who have completed curative-intent therapy. Patients undergoing imaging surveillance will be followed from 2012 to 2026 by linking EHRs with tumour registry data in the OneFlorida+ Clinical Research Consortium. Data will be consolidated into a unified repository to achieve three primary aims: (1) Examine the utilisation and determinants of CT imaging surveillance by race/ethnicity and socioeconomic status, (2) Compare clinical endpoints, including recurrence, SPLCs and survival of patients who undergo semiannual versus annual CT imaging and (3) Use the observational data in conjunction with validated microsimulation models to simulate imaging surveillance outcomes within the US population. To our knowledge, this study represents the first attempt to integrate real-world data and microsimulation models to assess the long-term impact and effectiveness of imaging surveillance strategies.

Ethics and dissemination

This study involves human participants and was approved by the University of Florida Institutional Review Board (IRB), University of Florida IRB 01, under approval number IRB202300782. The results will be disseminated through publications and presentations at national and international conferences. Safety considerations encompass ensuring the confidentiality of patient information. All disseminated data will be de-identified and summarised.

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Changes in prescription patterns of antidiabetic medication in patients newly diagnosed with type 2 diabetes in Spain: an observational study

Por: Cea-Soriano · L. · Moreno · A. · Calonge · M. · Rivas · A. · Pulido-Manzanero · J. · Colchero · M. C. · Artola · S. · Serrano · R. · Franch-Nadal · J. · Regidor · E. · the PRECOZIN Study Group · Adan · Almanzar · Alonso · Alonso · Alonso · Alvarez · Alvarez · Amoros · Araujo · Arbide
Objective

To estimate the frequency of antidiabetic prescriptions in type 2 diabetes mellitus (T2DM) in Spain and describe changes in prescription patterns between 2018–2022 and 2023-2024.

Design

Observational study.

Participants

Patients from primary care centres newly diagnosed with T2DM in 2018–2022 and 2023–2024.

Primary and secondary outcomes

In each period, the prescription frequency of an antidiabetic medication at the diagnosis of T2DM was calculated and subsequently subdivided into monotherapy and combination therapy. The prescription frequency of the most common antidiabetic drugs was also calculated. Calculations were made for the entire group of subjects and stratified by sex and age (under 60 years and 60 years or older). Comparison of the frequencies between the two periods was performed using the chi-square test.

Results

In 2018–2022 and 2023–2024, 78.4% and 88.9% of patients, respectively, were prescribed an antidiabetic medication. The prescription frequencies for monotherapy and combination therapy were 66.1% and 33.9% in the first period and 57.4% and 42.6% in the second. The prescription frequencies for metformin as monotherapy and combination therapy were 57.4% and 27.8% in the first period and 46.6% and 39.8% in the second. Prescribing metformin with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide receptor 1 agonists (GLP1a) was the most frequent combination therapy: 12.8% in 2018–2022 and 29.5% in 2023–2024. With a few exceptions, the prescribing pattern was similar by sex and age. The difference between the prescribing distributions in the two periods is significant.

Conclusion

Antidiabetic medication prescribing at the diagnosis of T2DM was high. Most prescriptions contained metformin. Monotherapy decreased in 2023–2024 compared with 2018–2022, while combination therapy increased due to increased prescriptions of metformin with SGLT2i and/or GLP1a.

Evaluating a population-based screening programme for early detection of liver fibrosis and cirrhosis in primary care in Germany: a cost assessment study

Por: Ortner · J. · Van Ewijk · R. · Velthuis · L. · Labenz · C. · Arslanow · A. · Nguyen-Tat · M. · Wörns · M.-A. · Reichert · M. C. · Farin-Glattacker · E. · Binder · H. · Fichtner · U. A. · Graf · E. · Stelzer · D. · Galle · P. R. · Lammert · F.
Objectives

Structured Early detection of Asymptomatic Liver fibrosis and cirrhosis (SEAL) is a population-based screening programme using non-invasive tests for the early detection of liver fibrosis. This study evaluates the cost implications if the SEAL programme were to be implemented in routine care in Germany.

Design

This study models cost differences with and without the SEAL screening programme. We regress costs of care on patient characteristics (age, comorbidities, sex, liver diseases, liver cancer and liver fibrosis and cirrhosis (LCI) stage) using statutory health insurance (SHI) data from routine care patients with LCI (n=4177). Based on these results, we predict per-patient costs for the patients newly diagnosed with LCI by SEAL (n=45). Costs with and without screening are estimated using patient age and LCI stage distributions from either SEAL or routine care.

Setting

SEAL was conducted in two German states. Initial screening was performed by patients’ primary care physicians.

Participants

Individuals insured by SHI without a prior diagnosis of LCI, eligible for Check-up 35, a general health check-up programme primarily targeting adults aged 35 and older, conducted by primary care physicians.

Interventions

Screening via aspartate aminotransferase to platelet ratio index in primary care, for further evaluation serological diagnostics and ultrasound examinations in secondary care and specific assessment for definite diagnosis including transient elastography and liver biopsy for selected cases in tertiary care.

Primary and secondary outcome measures

Primary outcome measures: expected 5-year cost changes for SEAL patients diagnosed with fibrosis or cirrhosis compared to costs without a screening programme. Secondary outcome measures: case mix of leading chronic liver disease and LCI stages among patients diagnosed with advanced fibrosis or cirrhosis in SEAL versus routine care without screening.

Results

Screening leads to fewer decompensated cases at initial diagnosis (4.6% in SEAL vs 22.8% in routine care) and thus savings in the costs of care within the first years of diagnosis: total expected costs per case were 2175 lower (bias-corrected bootstrap CIs (BCI): 527 to 3734), and LCI-associated costs were reduced by 1218 (BCI: 296 to 2164). Comparing the savings to the additional costs of diagnosis (range: 1575–1726 per detected LCI case) reveals that average changes in costs with screening range from moderate savings to moderate extra costs.

Conclusions

SEAL liver screening identifies patients in less advanced stages of LCI. If only costs were considered that are directly attributable to LCI, savings within 5 years are unlikely to fully outweigh the costs of screening. However, since this approach might miss additional LCI-related costs, SEAL appears to be cost-neutral compared with routine care when considering total healthcare costs.

Registration number

The SEAL registration number is DRKS00013460. This study relates to its results.

Efficacy of virtual reality in reducing pain, anxiety and fear in hospitalised children: a systematic review and meta-analysis protocol

Introduction

Paediatric hospitalisation, encompassing the period from admission to discharge, often involves feelings of pain, fear and anxiety, primarily due to clinical diagnoses and, more significantly, discomfort and stress-inducing procedures. Numerous methodologies and interventions have been investigated and implemented to alleviate these phenomena during paediatric hospitalisation. Virtual reality (VR), for example, has demonstrated efficacy in pain relief for hospitalised children in recent studies. This systematic review, therefore, aims to identify and evaluate the effectiveness of VR in alleviating pain, fear and anxiety in hospitalised children undergoing painful procedures.

Method and analysis

This systematic review and meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. A systematic search will be conducted in March and April 2025 across the following databases, with no restrictions on language or publication year: PubMed, Embase, Scopus, Web of Science, Cumulated Index in Nursing and Allied Health Literature, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Eligible studies will include randomised and quasi-randomised clinical trials involving children (aged 2–10 years) and adolescents (aged 10–18 years) who received VR interventions during painful procedures. Data will be managed and analysed using Review Manager software (RevMan 5.2.3). In cases of significant heterogeneity (I² > 50%), a random-effects model will be employed to combine studies and calculate the OR with a 95% CI. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias 2.0 tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluations framework.

Ethics and dissemination

This study will solely review published data; thus, ethical approval is not required. This systematic review is expected to provide subsidies, evidence and insights into the use of VR. It is also anticipated that the results will directly impact the improvement of care for these patients and the qualification of professional care.

PROSPERO registration number

CRD42024568297.

Development and psychometric evaluation of a new self-report measure to assess patient engagement behaviours and capacity in the USA: the Patient Engagement Capacity Survey

Por: Gregory · M. E. · Sieck · C. J. · Walker · D. M. · Di Tosto · G. · Edwards · M. C. · McAlearney · A. S. · Gebretsadik · S. · DeVos · T. V. · Hefner · J. L.
Objective

Patient engagement (PE), or a patient’s participation in their healthcare, is an important component of comprehensive healthcare delivery, yet there is not an existing, publicly available, measurement tool to assess PE capacity and behaviours. We sought to develop a survey to measure PE capacity and behaviours for use in ambulatory healthcare clinics.

Design

Measure development and psychometric evaluation.

Setting and participants

A total of 1180 adults in the USA from 2022 to 2024, including 1050 individuals who had indicated they had seen a healthcare provider in the prior 12 months who were recruited nationally via social media across three separate samples; 8 patient advisors and healthcare providers recruited from a large, midwestern US Academic Medical Center; and 122 patients recruited from five participating ambulatory clinics in the Midwestern USA.

Methods

An initial survey was developed based on a concept mapping approach with a Project Advisory Board composed of patients, researchers and clinicians. Social media was then used to recruit 540 participants nationally (Sample 1) to complete the initial, 101-item version of the survey to generate data for factor analysis. We conducted exploratory and confirmatory factor analyses to assess model and item fit to inform item reduction, and subsequently conducted cognitive interviews with eight additional participants (patient advisors and providers; Sample 2), who read survey items aloud, shared their thoughts and selected a response. The survey was revised and shortened based on these results. Next, a test–retest survey, also administered nationally via another round of social media recruitment, was administered two times to a separate sample (n=155; Sample 3), 2 weeks apart. We further revised the survey to remove items with low temporal stability based on these results. For clinic administration, research staff approached patients (n=122; Sample 4) in waiting rooms in one of five ambulatory clinics to complete the survey electronically or on paper to determine feasibility of in-clinic survey completion. We engaged in further item reduction based on provider feedback about survey length and fielded a final revised and shortened survey nationally via a final round of social media recruitment (n=355; Sample 5) to obtain psychometric data on this final version.

Primary and secondary outcome measures

Cronbach’s alphas, intraclass correlations (ICCs), Comparative Fit Index (CFI), root mean square error of approximation (RMSEA), standardised root mean squared residual (SRMR).

Results

The final PE Capacity Survey (PECS) includes six domains across two scales: ‘engagement behaviours’ (ie, preparing for appointments, ensuring understanding, adhering to care) and ‘engagement capacity’ (ie, healthcare navigation resources, resilience, relationship with provider). The PECS is 18 questions, can be completed during a clinic visit in less than 10 minutes, and produces scores which demonstrate acceptable internal consistency reliability (α=0.72 engagement behaviours, 0.76 engagement capacity), indicating items are measuring the same overarching construct. The scales also had high test–retest reliability (ICC=0.82 behaviours, 0.86 capacity), indicating stability of response over time, and expected dimensionality with high fit indices for the final scales (behaviours: CFI=0.97; RMSEA=0.07; SRMR=0.05; capacity: CFI=0.99; RMSEA=0.06; SRMR=0.06), indicating initial evidence of construct validity.

Conclusions

The PECS is the first known measure to assess patients’ capacity for engagement and represents a step toward informing interventions and care plans that acknowledge a patient’s engagement capacity and supporting engagement behaviours. Future work should be done to validate the measure in other languages and patient populations, and to assess criterion-related validity of the measure against patient outcomes.

Factors influencing HPV vaccine acceptance in immunosuppressed patient populations: a protocol for a systematic review

Introduction

The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.

Methods and analysis

A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.

Ethics and dissemination

This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023452537.

Two years and counting: a prospective cohort study on the scope and severity of post-COVID symptoms across diverse patient groups in the Netherlands--insights from the CORFU study

Por: Klein · D. O. · Waardenburg · S. F. · Janssen · E. B. N. J. · Wintjens · M. S. J. N. · Imkamp · M. · Heemskerk · S. C. M. · Birnie · E. · Bonsel · G. J. · Warle · M. C. · Jacobs · L. M. C. · Hemmen · B. · Verbunt · J. · van Bussel · B. C. T. · van Santen · S. · Kietelaer · B. L. J.
Importance

Little research has been done on post-COVID symptoms at 24 months postinfection and on the association these may have on health-related quality of life (HRQOL).

Objective

We assessed the prevalence and severity of post-COVID symptoms and quantified EuroQol 5 Dimension 5 Level (EQ-5D-5L), self-perceived health question (EuroQol Visual Analogue Scale (EQ-VAS)) and health utility scores (HUS) up to 24 months follow-up.

Design

The longitudinal multiple cohort CORona Follow-Up (CORFU) study combines seven COVID-19 patient cohorts and a survey among the general public. The participants received questionnaires on several time points. Participants were stratified by: without a known SARS-CoV-2 infection (control group), proven SARS-CoV-2 infection but non-hospitalised, proven SARS-CoV-2 infection hospitalised to the ward, and proven SARS-CoV-2 infection hospitalised to the intensive care unit (ICU).

Setting

In this study, data of seven COVID-19 patient cohorts and a survey among the general public are included.

Participants

Former COVID-19 patients and controls participated in this cohort study.

Main outcomes and measures

Former COVID-19 patients and non-COVID-19 controls were sent questionnaires on symptoms associated with post-COVID condition. The CORFU questionnaire included 14 symptom questions on post-COVID condition using a five-level Likert-scale format. Furthermore, HRQOL was quantified using the EuroQol EQ-5D-5L questionnaire: EQ-VAS and the EQ-5D-5L utility score. The EQ-5D-5L questionnaire includes five domains that are scored on a five-point Likert scale: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Results

A total of 901 participants (and 434 controls) responded at 24 months follow-up. In all former COVID-19 patients, the presence of post-COVID condition at 24 months was observed in 62 (42.5%, 95% CI 34.3% to 50.9%) of the non-hospitalised patients, 333 (65.0%, 95% CI 60.7% to 69.2%) of the hospitalised ward patients and 156 (63.2%, 95% CI 56.8% to 69.2%) of the ICU patients, respectively (p

Conclusions

Many former COVID-19 patients experience post-COVID symptoms at 24 months follow-up, with the highest prevalence in hospitalised participants. Also, former patients reported a lower HRQOL.

Trial registration number

The CORFU study was registered at clinicaltrials.gov (registration number NCT05240742).

Effectiveness of aromatherapy in pain relief postcardiac surgery: a systematic review and meta-analysis protocol

Introduction

Acute pain in the postoperative period of cardiac surgery is mostly treated with opioid analgesics. However, with the risk of adverse reactions and complications, strategies which do not involve opioid analgesics can be considered, such as aromatherapy. This systematic review aims to analyse the effectiveness of aromatherapy in relieving pain in post-cardiac surgery patients.

Methods and analysis

Two researchers will independently and simultaneously conduct searches and select studies from the following databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Literature on Health Sciences, Scopus, Web of Science, Cochrane (Library) and clinical trial registries (clinicaltrials.com), with no language or publication date restrictions. Randomised and quasi-randomised clinical trials on the use of aromatherapy for pain relief in postcardiac surgery patients will be included. Then, two researchers will independently examine the studies based on inclusion criteria, extract data from the included studies and assess the risk of bias using the Risk of Bias 2 tool and the Risk of Bias in Non-randomized Studies of Interventions tool from Cochrane. Data will be synthesised using Review Manager software. The strength of the evidence will be evaluated using the Grading of Recommendation Assessment, Development and Evaluation approach. The literature search, study selection, review and meta-analysis stages will be conducted from early October 2025 to April 2026.

Ethics and dissemination

This study is based on secondary data, and therefore ethical approval from a research ethics committee was not required. The results will be disseminated through publication in a peer-reviewed scientific journal.

PROSPERO registration number

CRD42024568532.

Transcranial direct current stimulation combined with physical exercise in knee osteoarthritis: a protocol for a randomised controlled clinical trial

Por: Lima · V. B. · Silva · C. A. M. · Silva · S. G. D. d. · Macedo · L. d. B. · de Souza · M. C. · Lins · C. A. d. A. · de Souza · C. G.
Introduction

Osteoarthritis (OA) is a degenerative and progressive joint condition causing pain and disability. Physical exercise is recognised as the most effective intervention since individuals with this condition often experience muscle weakness, balance deficits and chronic pain. Additionally, knee osteoarthritis (KOA) is associated with central sensitisation, contributing to chronic pain conditions. Transcranial Direct Current Stimulation (tDCS), a non-invasive neuromodulation technique, has been employed to induce changes in pain perception by altering cortical excitability, potentially reducing chronic pain.

Methods and analysis

This is a protocol for a randomised controlled trial. Participants will be allocated to two groups: G1 (active tDCS combined with exercise) and G2 (sham tDCS combined with exercise). The intervention protocol will last for 5 weeks, with two sessions per week on non-consecutive days. Pain intensity will be assessed as the primary outcome using the Numeric Rating Scale (NRS). The sample size was calculated based on a minimum clinically important difference of 3 points on the NRS between groups, with a statistical power of 80% and a significance level of 5%. Secondary outcomes will include physical function and global perceived change.

Ethics and dissemination

This protocol was approved by the Research Ethics Committee of the Trairi School of Health Sciences, Federal University of Rio Grande do Norte (Approval Number: 6.801.827), and it is in accordance with the Declaration of Helsinki for human research. Results will be published in peer-reviewed journals and presented at scientific events. This trial is registered in the Brazilian Clinical Trials Registry.

Trial registration number

Brazilian Clinical Trials Registry (RBR-5pb2g33).

Optical correction of hyperopia in school-aged children: a scoping review protocol

Por: Srinivasan · G. · Kerber · K. L. · Liu · S.-H. · Manh · V. M. · Huang · K. · Williamson · A. · Sadhu · S. · Ollinger · M. C. · Tajbakhsh · Z. · Fisher · J. H. · Cheung · N. L. · Junge · J. · Chan · K. C. H. · Hussaindeen · J. R. · Simard · P. · Trast · K. R. · Morettin · C. E. · Krueger
Introduction

Prescribing patterns for hyperopia in children vary widely among eye care providers worldwide. This scoping review aims to identify and map the current literature on optical correction and catalogue outcomes reported, particularly in the domains of vision, vision-related functional outcomes and quality of life (QoL) in school-aged children with hyperopia.

Methods and analysis

This protocol was developed in accordance with the Joanna Briggs Institute’s Manual for Evidence Synthesis. We will include studies involving school-aged children with hyperopia without restrictions on sex, gender, race, ethnicity, type of optical correction, length of intervention, publication date or country of origin. We will include studies with internal or external comparison groups. We will exclude studies associated with myopia control treatments, ocular and visual pathway pathologies affecting vision or visual function. We will search Cochrane CENTRAL, Embase.com and PubMed. Examples of data to be extracted include population demographics, visual acuity, study-specific definitions for refractive error, treatment regimens for optical correction, vision and vision-related functional outcomes and QoL (general or vision-related) as quantified by validated instruments.

Ethics and dissemination

Informed consent and Institutional Review Board approval will not be required, as this scoping review will only use published data. The results from the scoping review will be disseminated by publication in a peer-reviewed scientific journal and at professional conferences.

Comparative effectiveness of maintenance doses of opioid agonist treatment among individuals with opioid use disorder: a target trial emulation protocol using a population-based observational study

Por: Zanette · M. · Min · J. E. · Homayra · F. · Bach · P. · Socias · M. E. · Bruneau · J. · Korthuis · P. T. · Karim · E. · Seaman · S. · Bozinoff · N. · Kennedy · M. C. · Nosyk · B.
Introduction

Opioid agonist treatment (OAT) prescribing patterns have shifted in recent years in British Columbia (BC), Canada due to the increasingly toxic unregulated drug supply. Experimental evidence to support guidelines on the effectiveness of maintaining clients at different maintenance dosage levels is incomplete and outdated for the fentanyl era. Our objective is to assess the risk of treatment discontinuation and mortality among individuals receiving different maintenance dosage strategies for OAT with methadone, buprenorphine/naloxone or slow-release oral morphine (SROM) at the population level in BC, Canada.

Methods and analysis

We propose a retrospective population-level study of BC residents initiating OAT on methadone, buprenorphine/naloxone or SROM between 1 January 2010 and 31 December 2022 who were ≥18 years of age with no known pregnancy, no history of cancer diagnosis or receiving palliative care and not currently incarcerated. Our study will employ health administrative databases linked at the individual level to emulate a target trial per OAT type where individuals will be assigned to discrete maintenance dosing strategies, according to the full range observed in BC during the study period. Primary outcomes include treatment discontinuation and all-cause mortality. To determine the effectiveness of alternative maintenance doses, we will emulate a ‘per-protocol’ trial using a clone-censor-weight approach to adjust for measured time-dependent confounding by indication.

Ethics and dissemination

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. All data are deidentified, securely stored and accessed in accordance with provincial privacy regulations. 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.

Cluster randomised controlled trial of a household-level, group preconception nutrition awareness and norm intervention (SUMADHUR) combined with multiple micronutrient supplements (MMS) for newly married households: a protocol

Por: Diamond-Smith · N. · Puri · M. C. · Borak · L. · Walker · D. · Charlebois · E. · Weiser · S. D. · McDonald · C. M.
Introduction

Micronutrient deficiencies remain prominent drivers of adverse maternal and child health outcomes in Nepal. Gender-based inequalities and norms around women’s status and access to nutrition exacerbate poor nutritional status. Many newly married, preconception women lack adequate nutrition due to delayed engagement with the health system and limited autonomy to prioritise their own health. To address this gap, the Sumadhur trial provides multiple micronutrient supplements (MMS) alongside a household-level behavioural intervention targeting newly married women, their husbands and mothers-in-law.

Methods and analysis

This will be a village-cluster randomised controlled trial across three districts in Nepal, enrolling 700 households, each comprising a triad of newly married woman, husband and mother-in-law. Villages will be randomised to receive either Sumadhur behavioural intervention+MMS (intervention) or standard of care (control). In intervention villages, participants will join weekly group sessions for 5 months, covering maternal and reproductive health, equitable household food allocation and nutrition information, and gender norms and household relationships. Women will receive three bottles of MMS (180 tablets each) over 18 months. Quantitative data collection at baseline, 6, 12 and 18 months will include surveys, venous blood draws (not at 12 months) and anthropometry. Primary outcomes will be anaemia prevalence and micronutrient status (iron, folate, vitamin B12). Secondary outcomes will include reproductive behaviours, birth outcomes and intrahousehold relationship dynamics. A nested qualitative component will employ longitudinal in-depth interviews with triads to understand the mechanisms of behavioural change. Impact will be measured through an intention-to-treat approach using mixed-effects logistic regression analyses.

Ethics and dissemination

The study is approved by institutional review boards in the Ethics Board of the Nepal Health Research Council and the University of California, San Francisco IRB. Results will be disseminated to participating communities, local stakeholders and international audiences through workshops, peer-reviewed publications and policy briefs.

All data will be made publicly available (deidentified) after the publication of the main impact paper.

Trial registration number

NCT06810440.

Risk factors for unplanned readmissions in paediatric neurosurgery: a systematic review

Por: Sese · L. V. C. · Guillermo · M. C. L.
Objectives

Unplanned hospital readmission (UHR) after paediatric neurosurgery is an important indicator of surgical outcomes. As this field deals with complex cases, there is an increased likelihood of potential complications and the subsequent need for readmission. We estimated paediatric neurosurgery UHR rates globally and identified significant factors contributing to 30-day and 90-day UHR rates in children undergoing neurosurgical procedures.

Design

A systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources

Embase, Medline, CINAHL and Global Index Medicus databases were searched on 17th December 2023.

Eligibility criteria

We included studies that reported unplanned readmissions in the paediatric population within 30 days and 90 days of an index neurosurgical procedure.

Data extraction and synthesis

Two independent qualified researchers screened studies and extracted data using standardised methods. Risk of bias assessment was done using the Newcastle-Ottawa scale. Narrative synthesis was performed.

Results

2593 titles were identified following the search strategy. 52 studies were included after screening, full-text review and quality appraisal. Most studies were from the USA and are retrospective cohorts. The majority were cranial procedures (n=30), with common ones being shunt procedures for hydrocephalus and cranial tumour resections. 30-day readmissions ranged from 1.4% to 28% while 90-day readmissions ranged from 1.31% to 38.64%. 34 different risk factors were identified. Aetiology-related factors, procedure-specific complexities and age emerged as the three most common. Other common risk factors were complex chronic conditions, race, length of hospital stay and type of medical insurance. The patient’s age was a significant non-modifiable predictor, with younger children generally facing higher odds compared with their older counterparts across different procedures. While early readmissions could be due to disease progression, some were linked to preventable causes. Heterogeneity was also present due to variations in definitions and inclusion of studies from both national databases and single institutions.

Conclusions

Findings from this study contribute to a collective understanding of factors affecting unplanned readmissions in paediatric neurosurgery. UHRs reflect the interplay among surgical complexity, patient characteristics such as age and disease aetiology.

Comparison of outpatient attendance, cardiovascular risk management and cardiovascular health across preCOVID-19, during and postCOVID-19 periods: a prospective cohort study

Por: Zondag · A. G. M. · Haitjema · S. · de Groot · M. C. H. · de Boer · A. R. · van Solinge · W. W. · Bots · M. L. · Vernooij · R. W. M.
Objective

During the COVID-19 pandemic, a substantial decrease was observed in hospital admissions and in-hospital procedures for patients with acute cardiovascular diseases (CVDs). The extent to which measures to prevent COVID-19 transmission, for example, lockdowns, affected the outpatient care of patients at higher cardiovascular risk remains unclear. We aimed to compare outpatient department (OPD) attendance, cardiovascular risk management (CVRM) and cardiovascular health (CVH) of patients at higher cardiovascular risk referred to an OPD of a tertiary care centre between preCOVID-19, during and postCOVID-19 periods.

Design, setting and participants

We included all adult patients at higher cardiovascular risk referred to the cardiology, vascular medicine, diabetology, geriatrics, nephrology or multidisciplinary vascular surgery OPDs of the University Medical Centre Utrecht, the Netherlands, between March 2019 and December 2022, in a prospective cohort study.

Main outcome measures

We assessed trends in the number of first and follow-up appointments and in the completeness of extractable CVRM indicators from the electronic health record (EHR) as a proxy for CVRM guideline adherence. CVH was determined using the Life’s Essential 8 metric (score 0–100, the higher score, the better). We investigated whether CVH differed between COVID-19 periods compared with the reference period (ie, 2019) and stratified by OPDs, using multivariable linear regression, adjusted for age, gender, CVD history and whether the patient had a previous appointment before the reference period.

Results

Among 15 143 patients, we observed a 33% reduction in the weekly number of first appointments during the COVID-19 pandemic, with the largest reductions in the cardiology and nephrology OPDs, with no differences between women and men. Follow-up appointments conducted remotely, compared with before the COVID-19 pandemic, increased significantly for all OPDs. CVRM indicators were up to 11% less extractable during the first lockdown yet returned to prepandemic levels directly after the first lockdown period. The CVH score of patients visiting the nephrology, vascular medicine and geriatrics OPDs during the first lockdown was 11.23 (95% CI 2.74 to 19.72), 5.68 (95% CI 0.82 to 10.54) and 5.66 (95% CI 0.01 to 11.31) points higher, respectively, compared with the prepandemic period. In between the second and third lockdowns, the CVH score was comparable to the preCOVID reference period, yet for the cardiology OPD it was significantly higher (5.54, 95% CI 2.04 to 9.05).

Conclusions

During the COVID-19 pandemic, weekly numbers of first appointments to OPDs decreased, and a population with a higher CVH score (ie, better CVH) visited certain OPDs, especially during the first lockdown period. These suggest that patients with poorer CVH more often avoided or were unable to visit OPDs, which might have resulted in missed opportunities to control cardiovascular risk factors and potentially may have led to preventable disease outcomes. For future epidemics and pandemics, it seems vital to develop a strategy that includes an emphasis on seeking healthcare when needed, with specific attention to patients at higher CVD risk.

Recommendations for the use of biomarkers for the management of adults with sepsis: a scoping review and critical appraisal

Por: Mateos-Haro · M. · Garcia-Santa-Vinuela · A. · Molano-Franco · D. · Sola · I. · Gordo-Vidal · F. · Martin-Delgado · M. C. · Lopez-Alcalde · J. · Zamora · J.
Objective

A synthesis and appraisal of the recommendations for biomarkers in practice guidelines concerning sepsis is required to consolidate evidence-based practice. We generated an evidence gap map (EGM) on the use of biomarkers for managing adults with sepsis.

Design

Scoping review.

Data sources

MEDLINE, Guidelines International Network, Pan American Health Organization, Trip Database and UpToDate were searched from 2016 to March 2025.

Eligibility criteria

Guidance documents (GD) that searched at least one literature source and provided clinical recommendations for the use of biomarkers for the management (diagnosis and prognosis, including treatment response) of adults with sepsis.

Data extraction and synthesis

Two reviewers independently applied the eligibility criteria and extracted data. We used the AGREE-II (Appraisal of Guidelines for Research and Evaluation) tool to assess the GD quality. GDs that scored ≥50% on the AGREE-II 'Rigour of development' domain were considered robust. We also applied the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system to evaluate if the recommendations were strong or conditional.

Results

We found 10 GDs, with only half (4/8) having a robust methodology. There were 31 recommendations concerning biomarkers. Among these, 24 (77.4%) recommendations were about single biomarkers, with lactate (23; 74.2%) and procalcitonin (8; 25.8%) most frequently recommended. Biomarker testing focused on prognosis in 28 (90.3%) recommendations. Overall, 16 (51.6%) recommendations were graded strong and 13 (42.0%) were conditional, which we displayed in an EGM.

Conclusions

The methodology of GDs concerning adult sepsis was poor. Our review calls for more prudent use of biomarkers in specific prognostic scenarios and in combination with standard clinical assessments. Enhancing the methodological quality of future GDs is essential to generate more valid and robust recommendations for optimising patient care.

Are we ready for climate-friendly inhaler prescription and usage? A qualitative study among primary and secondary care patients, healthcare professionals and healthcare insurers in the Netherlands

Por: Oosterveld · B. · Broese · J. M. C. · Ossebaard · H. · van der Kleij · R. M. J. J.
Objectives

This study explored the knowledge and awareness of Dutch patients, healthcare professionals (HCPs) and healthcare insurers on the climate impact of inhalers as well as (factors influencing) their attitude towards climate-friendly inhaler prescription.

Design/setting

We recruited participants for this qualitative study with purposive sampling. We conducted four online focus groups with patients, six with HCPs and two interviews with healthcare insurer representatives. Determinants were analysed with the Framework Approach.

Participants

21 patients, 27 HCPs and two healthcare insurer representatives.

Results

Knowledge and awareness on the climate impact of inhalers varied and was generally lower among patients and healthcare insurers than among HCPs. The attitude towards climate-friendly inhaler prescription was variable among patients and mainly positive among HCPs. Both patients and HCPs assigned a greater role to HCPs than to patients in considering climate impact and agreed that patients’ interest must remain paramount. Factors influencing implementation were mainly related to outcome expectancies, such as expected effect on freedom of choice, expected response of patients and expected effect on patients’ health. The latter is partly influenced by beliefs about different types of inhalers. HCPs expressed a need for information and training on the topic and for collaboration with other stakeholders in the field of pulmonary care. Healthcare insurers assign themselves a role in a more climate-friendly healthcare but are reluctant to direct the preference policy on climate impact.

Conclusions

Both patients and HCPs feel climate-friendly inhaler prescription is important. Implementation can be promoted by enhancing awareness and providing HCPs with information on inhaler climate impact, how to safely practice climate-friendly prescription and how to inform patients about its benefits. Both patients and HCPs emphasise the significance of preserving freedom of choice in prescription and highlight the need for a consensus approach on climate-friendly prescribing endorsed by all pulmonary care stakeholders.

EARLYBIRD: catching the earliest changes of the bone and intervertebral discs in children at increased risk for scoliosis development with MRI - study protocol of a prospective observational cohort study

Por: Lafranca · P. P. G. · Stempels · H. W. · de Reuver · S. · Houben · M. L. · Kok · J. · Kruyt · M. C. · Castelein · R. M. · Seevinck · P. R. · van der Velden · T. · Shcherbakova · Y. M. · Ito · K. · Schlösser · T. P. C.
Introduction

Adolescent idiopathic scoliosis (AIS) is an acquired deformity that develops in 2–4% of otherwise healthy children during adolescent growth, substantially reducing their quality of life and creating a life-long burden of disease. Despite many years of dedicated research, the cause and mechanism of AIS are still unknown and no effective curative treatments are available for children suffering from this spinal and chest deformity. To date, all etiological studies focused on children with an already established scoliosis. EARLYBIRD aims to uncover the earliest pathoanatomical changes in AIS, by studying longitudinal spinal growth in children at increased risk for scoliosis development with MRI, starting before adolescence.

Methods and analysis

This prospective observational cohort study will follow two groups: 60 adolescent girls (8–10 years old) who have an older sibling or parent diagnosed with AIS (cohort 1) and 60 adolescents with 22q11.2 deletion syndrome, a genetic microdeletion associated with 50% scoliosis prevalence (cohort 2). Data collection will be completely radiation-free and occur at baseline and yearly during adolescence up to 15 years of age in girls and up to 16 in boys. A comprehensive physical examination, a dedicated spine and chest MRI as well as a standing three-dimensional (3-D) spinal ultrasound will be obtained at each time point. The main parameter will be the longitudinal changes in segmental axial rotation during growth in subjects that do and do not develop AIS. Secondary endpoints are longitudinal changes in 3-D morphology of the bone and intervertebral discs (IVDs) during normal spinal development and during scoliosis development, determining biomarkers for bone growth, implementing radiation-free imaging methods for spinal monitoring in adolescent patients at risk for scoliosis development and use these for spinal skeletal maturity and patient-specific spinal biomechanical analyses.

Ethics and dissemination

This protocol has been approved by the Medical Ethics Committee NedMed and is registered on clinicaltrials.gov (NCT05924347). Written informed consent will be obtained from all parents/legal representatives. Key findings will be disseminated via peer-reviewed journals and presentation at conferences. This study is funded by the European Research Council.

Safety and feasibility of allogeneic cord blood-derived cell therapy in preterm infants with severe brain injury (ALLO trial): a phase-1 trial protocol

Por: Razak · A. · Connelly · K. · Hunt · R. W. · Miller · S. L. · McDonald · C. A. · Jenkin · G. · Zhou · L. · Paton · M. C. · Martin · M. · Liu · L. · Hart · C. · Elwood · N. J. · Malhotra · A.
Introduction

Severe intraventricular haemorrhage (IVH) and white matter injury (WMI) are major neurological complications in preterm infants, leading to long-term neurodevelopmental impairments. Despite advances in neonatal care, effective treatments are lacking. Umbilical cord blood cell (UCBC) therapy shows neuroprotective potential, with autologous sources ideal but often not feasible due to the unpredictability of preterm births. Allogeneic UCBCs offer an alternative, although immunogenicity and human leucocyte antigen (HLA) compatibility present challenges with knowledge gaps in their relevance in neonatal populations. This study aims to assess the feasibility and safety of partially HLA-matched allogeneic UCBC therapy in preterm infants with severe brain injury.

Methods

The ALLO trial is an open-label, phase I, single-arm feasibility and safety study conducted at Monash Children’s Hospital, Victoria, Australia. Preterm infants born before 28 weeks (ALLO-1) or between 28 weeks and 36+6 weeks (ALLO-2) gestational age with severe brain injury identified on neuroimaging will be enrolled. Severe brain injury is defined as grade 3 or 4 IVH or significant WMI. Exclusion criteria include major congenital anomalies or redirection to comfort care. Eligible infants will receive a single intravenous infusion of unrelated, allogeneic, partially HLA-matched (4/6 or 5/6 HLA match) UCBCs sourced from a public cord blood bank. The target dose is 50 million total nucleated cells per kilogram body weight. Infusion will occur within 2–3 weeks of confirmation of eligibility, contingent on clinical stability and absence of active sepsis. Primary outcome includes: (1) feasibility, defined as having more than 60% of enrolled infants with an eligible allogeneic partially matched cord blood unit available and (2) safety, defined as absence of severe adverse events within 48 hours of infusion or graft-versus-host disease within 3 months of infusion. Secondary outcomes include survival, neonatal morbidities, neurodevelopmental assessments and serum cytokine analysis.

Ethics and dissemination

Monash HREC has granted full ethics approval (RES-23-0000-297A) for the study, including the research use of allogeneic cord blood from compassionate donations by healthy donors, facilitated through the Bone Marrow Donor Institute Cord Blood Bank within the AusCord network. Findings will be disseminated through peer-reviewed publications and conference presentations, contributing to the development of novel neuroreparative therapies for preterm brain injury.

Trial registration number

ACTRN12623001352695 (The Australian New Zealand Clinical Trials Registry).

Comparison of elective hemicolectomy patients before and after establishment of a preoperative anaesthesia assessment clinic: a retrospective, observational study in a hospital in Norway

Por: Kristoffersen · E. W. · Fossum · M. · Tveit · T. O. · Berge · G. T. · Hagen · M. C. · Opsal · A.
Objectives

To compare outcome data of hemicolectomy patients before and after the establishment of a preoperative anaesthesia assessment clinic (PAC).

Design

This observational study was conducted retrospectively through an electronic health record review covering periods before (2014–2017) and after (2017–2022) the PAC was established.

Setting

An acute care hospital in Norway.

Participants

A total of 612 patients undergoing elective open or laparoscopic hemicolectomy were included, of whom 338 (55.2%) had attended the PAC.

Primary and secondary outcome measures

The primary outcome was the rate of cancellation of planned surgeries, and the secondary outcomes were length of hospital stay (LOS), unanticipated intraoperative anaesthesia-related events and the presence of documentation relevant to the planning of anaesthesia in the patient’s medical records preoperatively.

Results

Compared with the after-PAC cohort, the before-PAC cohort was numerically more likely to have their planned surgery cancelled (OR=1.97, 95% CI (0.84 to 4.61); p=0.12). The before-PAC cohort also had a numerically lower rate of unanticipated intraoperative anaesthesia-related events (18.6%) than the after-PAC cohort (22.5%; p=0.240). However, neither of these differences was statistically significant. Median LOS was significantly shorter in the after-PAC cohort (4.79 days, IQR (3.80–6.12)) than in the before-PAC cohort (5.16 days (4.09–7.18); p=0.001). Moreover, the presence of documentation relevant to the planned anaesthesia in the medical records was significantly more common for after-PAC patients.

Conclusions

The establishment of the PAC reduced the rate of planned surgery cancellations but increased the rate of recorded intraoperative anaesthesia events. Patients who attended the PAC had a significantly shorter LOS and more anaesthesia-related information in their medical records.

Trial registration number

NCT05520229.

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