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Ayer — Octubre 2nd 2025Tus fuentes RSS

Barriers and enablers to healthcare access for older adults in Cambodia: perspectives of healthcare professionals - a qualitative study

Por: Maung · K. T. · Phou · S. · Hunsberger · M. · Santosa · A. · Ng · N. · Sopheab · H. · Chhea · C. · Eriksson · M.
Objective

To explore health professionals’ perspectives on the barriers and enablers of healthcare access for older adults in Cambodia.

Design

A qualitative study based on semi-structured interviews conducted in Khmer, recorded, transcribed, translated into English and analysed using an abductive thematic analysis approach.

Setting

Phnom Penh, Cambodia.

Participants

A purposive sample of 11 health professionals serving in diverse roles and sectors participated in the study.

Results

Three key barriers emerged: (1) institutional barriers, (2) patient-specific access barriers and (3) communication barriers. However, four key enablers were also identified: (1) supportive healthcare environment, (2) reaching out to improve access to health services, (3) peer and community engagement and (4) government direct support to access healthcare. Despite previous policy efforts, gaps in the implementation of healthcare services for older adults persist across all health facilities. Health professionals identified that improving healthcare access for older adults in Cambodia requires a multifaceted strategy involving proactive outreach, health promotion, financial assistance and stronger community and family support.

Conclusion

Effective policy implementation requires collaboration among stakeholders and the active involvement of older adults in programme design to enhance dignity and well-being in Cambodia’s ageing population.

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Understanding Canadian experiences of suicidality during the COVID-19 pandemic: protocol of a pan-Canadian qualitative study

Por: Baharikhoob · P. · Hollenberg · E. · Cuperfain · A. B. · Rudoler · D. · Nicoll · G. · Blumberger · D. · Bolton · J. · Chartier · G. B. · Crawford · A. · Furqan · Z. · Gajaria · A. · Gratzer · D. · Hatcher · S. · Husain · M. I. · Kurdyak · P. · Lam · J. S. H. · Lavergne · M. R. · Marshall
Introduction

The COVID-19 pandemic led to major disruptions in society across many spheres, including healthcare, the economy and social behaviours. While early predictions warned of an increased risk of suicide during and after the COVID-19 pandemic, rates of suicide deaths remained stable or decreased over that period for most countries. In contrast, the prevalence of suicidal ideation doubled and suicide attempts slightly increased during the COVID-19 pandemic in the adult general population worldwide, accompanied by a higher prevalence of major depressive disorder and anxiety disorders. While these data can tell us what happened, they cannot tell us why. Qualitative suicide research seeks to understand experiences of individuals with suicide-related thoughts and behaviours, provides an in-depth exploration of their lives and interactions with others and centres their views and unique context. There is little qualitative research focusing on suicidality during the pandemic. This study will use a qualitative approach to explore the extent and impact of the COVID-19 pandemic on Canadians who experienced suicidality and review their experiences of accessing mental healthcare to identify key components in supporting safety and recovery.

Methods and analysis

This study will involve approximately 100 semistructured interviews with participants across four Canadian provinces and will explore experiences with suicide-related thoughts and behaviours during the COVID-19 pandemic. Transcripts will be analysed through qualitative analysis informed by constructivist grounded theory.

Ethics and dissemination

The study was approved by the Research Ethics Board of the Centre for Addiction and Mental Health, Toronto Academic Health Sciences Network (for JZ: CAMH REB No 104-2022). In addition to traditional peer-reviewed presentations and publications, a report will make study findings accessible to policy makers, media and the public.

Randomised controlled study investigating standard dose continuous renal replacement therapy (CRRT) versus low-dose CRRT in critically ill patients with acute kidney injury (AKI): study protocol for a prospective, randomised, controlled, international, mu

Por: Strauss · C. · Sadjadi · M. · von Groote · T. · Booke · H. · Schöne · L. M. · Hegner · C. · Wempe · C. · Meersch · M. · Gerss · J. · Bernard · A. · Haeberle · H. A. · Rosenberger · P. · Rahmel · T. · Unterberg · M. · Adamzik · M. · Arndt · C. · Wulf · H. · Romagnoli · S. · Bonizzoli · M.
Introduction

The only supportive therapy for patients with severe acute kidney injury (AKI), a common complication among the critically ill, is dialysis. Based on the literature and current guidelines, continuous renal replacement therapy (CRRT) with a total effluent dose of 20–25 mL/kg/hour and adjustments to ensure such dose is delivered despite down time (eg, due to surgical procedures) is recommended. However, experimental and clinical studies suggest that azotaemia, which can be induced by lowering the effluent dose, may accelerate renal recovery. This clinical study investigates whether a lower effluent dose (10–15 mL/kg/hour) for a maximum of 7 days or until successful (>24 hours) liberation of CRRT in critically ill patients with a dialysis-dependent AKI accelerates renal recovery and reduces time on CRRT compared with guideline-directed standard dose (25–30 mL/kg/hour).

Methods and analysis

The Ketzerei trial is an international, multicentre randomised, controlled trial, designed to investigate if a lower effluent dose (10–15 mL/kg/hour) accelerates renal recovery and reduces the time on CRRT compared with the guideline directed standard effluent dose (25–30 mL/kg/hour). The study aims to enrol 150 critically ill patients with a dialysis-dependent AKI. Eligible patients will be randomised to receive either a standard effluent dose (control group, 25–30 mL/kg/hour) or lower effluent dose (interventional group, 10–15 mL/kg/hour). The primary endpoint is the number of days free from CRRT and alive (from randomisation through day 28). Key secondary endpoints include the number of (serious) adverse events due to potential uremia, the duration of RRT and intensive care unit survival.

Ethics and dissemination

The Ketzerei trial has been approved by the Ethics Committee of the Chamber of Physicians Westfalen-Lippe (2023–343 f-s), the University of Muenster and subsequently by the corresponding Ethics Committee of the participating sites. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research.

Trial registration number

clinicaltrials.gov (NCT06021288).

Development of intersectoral medical care for patients with 'chronic critical illness: protocol for a telemedicine interventional study with a pre-post design in out-of-hospital intensive care facilities (E=MC{superscript 2})

Por: Edel · A. · Jöbges · S. · Weiss · B. · Paul · N. · Lyall · M. L. · Hoffmann · C. · Schüürhuis · S. · Piper · S. K. K. · Konietschke · F. · Berger · E. · Busse · R. · Marschall · U. · Kraufmann · B. · Witzenrath · M. · Eckardt · K.-U. · Spies · C.
Introduction

Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.

Method and analysis

This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.

Ethics and dissemination

This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.

Trial registration number

This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).

Public perceptions of digitalisation and patient safety: a cross-sectional survey in Germany

Por: Amberger · O. A. · Lemke · D. · Müller · H. · Lüttel · D. · Schwappach · D. · Geraedts · M. · Müller · B. S.
Objectives

To explore perceptions of digitalisation and patient safety from the view of the German general public and related sociodemographic factors.

Design

Cross-sectional survey.

Setting

A nationwide survey was undertaken in 2024, using data from the Techniker Krankenkasse (TK) Monitor of Patient Safety. The TK Monitor of Patient Safety is an annual survey of the population on the state of patient safety in medical care.

Participants

1000 German adults (18 years and older).

Primary and secondary outcome measures

Ordinal logistic regression analyses were performed to investigate the associations among sociodemographic factors (age, gender, education and household income) and perceptions on digitalisation and patient safety.

Results

The majority of respondents expected benefits from digital applications in healthcare. Over half of the respondents (58%) believed that artificial intelligence (AI) can help reduce complications and errors, while 49% of the respondents believed that the use of AI poses serious new risks for the healthcare sector. The results showed that sociodemographic variables are important factors influencing patient safety perceptions of digitalisation and AI. Female, older, less educated and/or lower-income individuals were less likely to perceive benefits from digital care applications and AI.

Conclusions

In our study, the German public appears to view digital technologies and AI as tools both for improving patient safety and as potential risk factors. Our findings also highlight the importance of analysing sociodemographic factors to identify specific disparities in how different groups are affected by digitalisation. Such analysis is essential for developing targeted strategies that mitigate current patient safety risks, ensuring that digital health solutions are equitable and safe across all demographic groups.

Nurses' Self‐Reported Practices and Prescribers' Expectations in Intravenous Fluid Therapy for Hospitalised Patients: A Survey Study and Clinical Documentation Review

ABSTRACT

Aims

To assess self-reported practices and knowledge of nurses and prescribers (i.e., physicians and nurse practitioners) on intravenous fluid therapy, and to evaluate how this is documented through a clinical documentation review.

Design

Multicentre cross-sectional study, between April 2022 and July 2022, across 13 wards from four Dutch hospitals.

Methods

A survey study was conducted to assess self-reported practices related to intravenous fluid therapy. A 12-item questionnaire evaluated knowledge. To gain insights into documentation practices, a retrospective chart review was performed. Data analysis involved descriptive statistics, with group differences analysed using the chi-squared test or Fisher's exact test, as appropriate.

Results

Three hundred and four healthcare professionals completed the questionnaire (92% nurses). The majority of prescribers (n = 20/25; 80%) expected that nurses would start, stop or change intravenous fluid therapy. Overall, the median number of correct answers to knowledge questions was eight (IQR 7–9, range 0–12); four participants (1%) answered all knowledge questions correctly. Knowledge about the composition of sodium chloride 0.9% solution was limited. Analysis of patient charts revealed that 54% (196/362) received intravenous fluids, most commonly 0.9% sodium chloride infusion (168/195; 86%), although the indication was described in 3% (6/196). Thirty-one percent (61/196) of patients received intravenous fluids to keep the vein open (< 30 mL/h).

Conclusion

The study identified shared responsibility, a knowledge gap, and limited documentation concerning intravenous fluids. Prescribers expect nurses to adjust intravenous fluids without consulting a prescriber, which aligns with what nurses do, although they are not legally authorised. Given the limited documentation of the indication for intravenous fluids, it is plausible that several patients received intravenous fluids unnecessarily.

Implications

The perceived shared responsibility presents an opportunity to develop a protocol engaging both prescribers and nurses, aiming to guide more targeted infusion therapy.

Impact

Reducing unnecessary infusions to keep-the-vein-open can help eliminate low-value care.

Reporting Method

CROSS guideline.

Patient or Public Contribution

No patient or public contribution.

Propofol-based versus sevoflurane-based anaesthesia for deceased donor kidney transplantation: the VAPOR-2 study protocol for an international multicentre randomised controlled trial

Por: Huisman · G. J. J. · Berger · S. P. · Thyrrestrup · P. S. · Hausken · J. · Veelo · D. P. · Guirado · L. · Pol · R. · Jensen · L. L. · Tonnessen · T. I. · Bemelman · F. J. · Facundo · C. · THE VAPOR-2 STUDY GROUP · Tamasi · K. · Lunter · G. · Jespersen · B. · Leuvenink · H. G. D. · Str
Introduction

Ischaemia reperfusion injury (IRI) is inevitable in kidney transplantation and negatively affects patient and graft outcomes. Anaesthetic conditioning (AC) refers to the use of anaesthetic agents to mitigate IRI. AC is particularly associated with volatile anaesthetic (VA) agents and to a lesser extent to intravenous agents like propofol. VA like sevoflurane interferes with many of the processes underlying IRI and exerts renal protective properties in various models of injury and inflammation. We hypothesise that a sevoflurane-based anaesthesia is able to induce AC and thereby reduce post-transplant renal injury, reflected in improved graft and patient outcome, compared with a propofol-based anaesthesia in transplant recipients of a deceased donor kidney.

Methods and analysis

Investigator-initiated, multicentre, randomised, controlled and prospective clinical trial with two parallel groups. The study will include 488 kidney transplant recipients from donation after brain death (DBD) or donation after circulatory death (DCD) donors. Participants are randomised in a 1:1 design to a sevoflurane (intervention) or propofol (control) group. The primary endpoint is the incidence of delayed graft function in recipients of DCD and DBD donor kidneys and/or 1-year biopsy-proven and treated acute rejection. Secondary endpoints include functional delayed graft function defined as failure of serum creatinine levels to decrease by at least 10% per day for three consecutive days; primary non-function is defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kinds, estimated glomerular filtration rate at 1 week and 3 and 12 months calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; readmissions at 3 and 12 months, graft survival and all-cause mortality at 12 months.

Ethics and dissemination

The study is approved by the local ethical committees and national data security agencies. Results are expected to be published in 2025.

Trial registration number

NCT02727296.

Effects of manual therapy on oral opening, swallow function and upper quarter mobility in Chilean survivors of head and neck cancer: a study protocol for a controlled, randomised study (MAnual ThErapy for Oral Opening (MATEO) study)

Introduction

Head and neck cancer (HNC) accounts for over 4% of global cancer incidence, yet the oncological treatment induces several sequelae such as oral dysfunction, cervical and shoulder impairments or pain that are not well addressed. Thus, survivors of HNC (sHNC) perceive a decrease in their quality of life (QoL). This study protocol aims to investigate the effects of manual therapy (MT) to determine the effectiveness and safety on oral opening, swallow function and upper quarter mobility, cervical muscle strength, pain, functionality and QoL of sHNC.

Methods and analysis

A randomised controlled trial will include 70 sHNC over 18 years of age and will be divided into two groups. Intervention will last for 6 weeks with a total of 18 sessions, including MT targeting mastication and head and neck muscles. The control group will receive motor control exercises. The main outcomes will be oral opening and swallow function. An intention-to-treat analysis will be performed to evaluate the effectiveness of the intervention, which will be further determined with the calculation of effect sizes expressed in Cohen’s d.

Ethics and dissemination

The study was approved by the Ethics Committee of the Universidad de La Frontera (File 001_24) according to the Helsinki Declaration for Biomedical Research. All participants will provide informed consent. Study results will be published in open access peer-reviewed journals and may be shared at relevant meetings and research meetings.

Trial registration number

This trial was registered with ClinicalTrials.gov on 28 November 2023 (code: NCT06148077).

Treatments for Pyoderma Gangrenosum: A Systematic Review and Single‐Arm Meta‐Analysis of Systemic Therapies

ABSTRACT

Pyoderma gangrenosum (PG) is a neutrophilic dermatosis associated with significant morbidity and mortality, with no consensus treatment to date. To review all clinical trials of treatments for PG to synthesise clinical evidence regarding the efficacy and safety of different treatments. After PROSPERO (CRD42023459180) registration, we systematically searched five databases (clinicaltrials.gov, CENTRAL, Embase, PubMed and Scopus) up until 18th May 2024 for PG treatments. Of 10 579 identified articles, 5853 deduplicated abstracts were screened. Twenty studies met the screening criteria after a full text review of 60 articles. We assessed the risk of bias using ROBIN-I for non-randomised and ROB-2 for randomised trials. Two reviewers independently performed article screening and quality assessments. Two reviewers independently extracted and recorded data on study characteristics, participants' demographics, disease characteristics, treatment regimens, and outcomes for the selected studies. A single-arm meta-analysis of available RCTs and non-randomised studies was conducted to analyse the outcomes of different systemic immunomodulators. The primary outcome was the complete healing of PG. Secondary outcomes included rates of recurrence, treatment failure, adverse events and time to complete healing. A total of twenty (20) interventional studies were included in the data synthesis: nine (9) prospective open-label studies, six (6) prospective cohort studies, three (3) open-label clinical trials, and two (2) randomised controlled trials evaluating multiple biological, systemic, and topical interventions. On random effects meta-analysis of systemic therapies including adalimumab, canakinumab, infliximab, chlorambucil, cyclosporine, cyclophosphamide and prednisolone, the pooled proportion of complete healing across 11 studies was 0.59 (95% confidence interval [CI]: 0.41–0.74; Χ 2 = 26.66, p < 0.01; I 2 = 66%); the pooled proportion of PG recurrence across 6 studies was 0.30 (95% CI: 0.20–0.41; Χ 2 = 1.14, p = 0.95; I 2 = 0%); the pooled proportion of serious adverse effects from 4 studies was 0.10 (95% CI: 0.05–0.19; Χ 2 = 5.01, p = 0.17; I 2  = 40%); and the pooled proportion of PG treatment failure across seven studies was 0.36 (95% CI: 0.24–0.49; Χ 2 = 12.78, p = 0.03; I 2 = 61%). The proportion of complete wound healing varies significantly across treatments and recurrence is common even in a limited follow-up period. Heterogeneity of study methods and low numbers hamper disease research. There remains a significant unmet need for better outcome measures than just complete healing as well as better treatment options to improve patient outcomes.

Trends in public perceptions of patient safety during the COVID-19 pandemic: Findings from a repeated cross-sectional survey in Germany, 2019–2023

by Olga Amberger, Dorothea Lemke, Hardy Müller, David Schwappach, Max Geraedts, Beate S. Müller

In recent years, public perceptions of patient safety have evolved significantly, driven by media coverage, healthcare reforms, and greater awareness during the coronavirus disease 2019 (COVID-19) pandemic. The present study aimed to examine trends in public perceptions of patient safety, knowledge and self-efficacy in Germany during this pandemic between 2019 and 2023. A repeated cross-sectional study was conducted, using data from TK Monitor of Patient Safety. TK Monitor of Patient Safety in a nationwide survey assessing public perceptions of safety in medical treatment and diagnosis. Self-reported data were collected annually from a randomly selected sample of 1,000 different adults aged 18 and older residing in Germany. Statistical analyses included descriptive statistics, chi-square tests, and linear regressions for trend analyses. Our results revealed high perceived patient safety risk during the years of the study. Up to one third of respondents considered it very likely or somewhat likely that patients would be harmed when receiving medical treatment in hospital or ambulatory care, with lower perceived levels of risk before the COVID-19 pandemic. Regarding perceived prevalence of preventable adverse events, over half of respondents considered it very likely or somewhat likely that an illness of theirs would be diagnosed incorrectly, or that they would contract a nosocomial infection, at some stage in their lives. The majority of respondents considered themselves overall well informed about patient safety and reported higher levels of self-efficacy with regard to error prevention before and after the pandemic than during it. Given the facts that patient safety remains an important issue and that the German public perceives the level of patient safety risk but also of patient safety knowledge, and self-efficacy as high, actively involving patients in safety initiatives is essential for shaping positive public perception.

PhD Virtual Connect: Exploring the Development of a Community of Practice in Nursing Doctoral Education

ABSTRACT

Background

Virtual scholarly events play an increasing role in doctoral education, particularly in nursing. The PhD Virtual Connect-event has been held annually for the past decade, evolving as a platform for engagement, knowledge exchange and professional development. However, its potential as a structured virtual Community of Practice remains underexplored.

Aim

This study explores the experiences of PhD students participating in the 9th and 10th editions (2023 and 2024) of the Sigma Theta Tau European Region's PhD Virtual Connect, examining how they perceive its alignment with Community of Practice principles and its role in doctoral nursing education.

Method

A qualitative, open-ended survey was administered to the event participants who presented their studies across both editions, with responses being analysed using reflexive thematic analysis, followed by a comparative discussion of findings.

Results

A total of 36 participants answered the survey. The analysis identified four key themes: developing a scholarly identity, reciprocity in feedback, structuring engagement and broadening research perspectives. Participants highlighted the event's role in strengthening academic confidence and fostering a sense of belonging. A shift towards peer-driven feedback and structured engagement in 2024 reflected increasing demand for organised discussions and thematic breakout sessions. These findings support the event's function as a dynamic Community of Practice, where participants co-construct knowledge, refine collaborative processes and navigate interdisciplinary learning.

Conclusion

The PhD Virtual Connect fosters scholarly engagement, mentorship and interdisciplinary exchange as an evolving virtual Community of Practice. While it sustains meaningful academic interaction, addressing digital inequities, enhancing interactive elements and formalising mentorship structures will be key to ensuring long-term inclusivity and engagement. Future research should examine the long-term impact of the virtual Community of Practice on academic career trajectories and professional networking in doctoral education.

Patient or Public Contribution

No Patient or Public Contribution. This study focused on PhD nursing students' experiences in a virtual scholarly event, involving only academic participants. As it was not a healthcare intervention or service-related study, patient or public involvement was not applicable.

Cohort profile: Mother and Infant Metabolome and Microbiome (MIMM) study, a prospective cohort study of mothers and infants in Boston, Massachusetts

Por: Andrews · C. · Vodapally · S. · Foster · L. P. · Lawandy · I. · Murphy · M. · Castellanos · M. · Moncada · D. · Mourao · M. L. · Bhushan · B. · Berger · P. K. · Fichorova · R. · Monthe-Dreze · C. · Freedman · S. D. · Angelidou · A. · Martin · C. R. · Sen · S.
Purpose

Breastfeeding is beneficial to the health of both the mother and infant. Despite recommendations to breastfeed by organisations including the WHO and the American Academy of Pediatrics, rates of breastfeeding remain below public health goals. The Mother and Infant Metabolome and Microbiome (MIMM) study is a prospective cohort study of healthy mother-term infant dyads designed to comprehensively assess the perinatal, maternal, neonatal and infant factors that are associated with breastfeeding outcomes and human milk composition.

Participants

MIMM participants were recruited from two medical centres in Boston, Massachusetts, from 2019 to 2023 and are followed for 2 years. Dyads were included if the mother delivered a singleton infant at ≥37 weeks’ gestation, was discharged home 2 and infant gestational age was 39.3 weeks. Approximately 43% of infants were born via caesarean delivery, and 45.5% were female.

Findings to date

MIMM study procedures include longitudinal (1) collections of maternal blood, vaginal swab, stool and milk and infant blood and stool samples and (2) assessments of breastfeeding status, child neurodevelopment and growth and maternal health at birth, 6 weeks and 6, 12, 18 and 24 months. Data collection through 18 months is complete. The overall objective of the MIMM study is to identify potential targets to improve breastfeeding outcomes, human milk composition and ultimately, maternal and child health. Preliminary analyses, reported in conference presentations (with ongoing analyses and results manuscripts pending), have found that (1) mothers with higher levels of stress were less likely to be exclusively breastfeeding their infants at 6 weeks; (2) higher breastfeeding intensity was associated with greater postpartum weight loss at 6 weeks; (3) feeding type was a more relevant predictor of feeding frequency and volume compared with feeding mode; (4) infants who received exclusive human milk had higher food enjoyment compared with those who received any formula; and (5) infants of mothers with obesity had higher average feeding volume per feed.

Future plans

Data collection for the final 24-month visit is expected to be completed by August 2025. We expect that all sample assays will be completed by December 2025. Findings will continue to be submitted for presentation at scientific conferences, and we expect to publish the first findings from this cohort in manuscript format in 2025.

Experiences of adopting remote technologies for blood pressure control among women with pre-eclampsia and healthcare providers: a systematic review of qualitative studies

Por: Srimoragot · M. · Nuampa · S. · Saenkla · P. · Hershberger · P. E.
Introduction

Pre-eclampsia is a harmful and potentially life-threatening condition affecting maternal health and fetal well-being. In response to the need for timely and continuous monitoring, remote health technologies have been implemented for blood pressure control among this group over the last decades. The purpose of this study is to synthesise qualitative evidence on the experiences of adopting remote technologies for blood pressure control among women with pre-eclampsia and their healthcare providers.

Methods

Peer-reviewed publications published in English from January 2013 to March 2023 were searched using seven electronic databases: PubMed, Nursing & Allied Health Premium (ProQuest), Scopus, ScienceDirect, Taylor & Francis Online, Google Scholar and EBSCO Open Dissertations. The findings were subjected to meta-synthesis using the Joanna Briggs Institute meta-aggregation approach, whereby credible and unequivocal findings supported by participant quotations were extracted, grouped into categories and then integrated into synthesised findings through consensus among reviewers. A total of 4827 studies were identified in the initial database search. Twelve eligible studies were included in the meta-synthesis.

Results

Among 12 studies, five synthesised findings were elicited from women’s experiences with remote monitoring, including reassurance and increased self-confidence in health, a sense of autonomy, enhanced awareness of their health, acceptability and satisfaction with telehealth and reduced anxiety and stress. Providers’ perspectives on telehealth were presented in four synthesised findings: increasing value for oneself and work, strengthening knowledge and skills on pre-eclampsia, improving quality of care and concerns about technology challenges.

Conclusion

Healthcare providers reported professional growth and improved care delivery, though technical challenges persist. These findings support the integration of remote monitoring into maternal healthcare.

Conditioned open-label placebos to facilitate opioid reduction in patients with chronic non-cancer pain: study protocol of a randomised controlled trial

Por: Carratta · K. · Bodonyi · K. · Frey Nascimento · A. · Friis · D. · von Känel · R. · Bircher · L. · Koechlin · H. · Bernstein · M. · Streitberger · K. · Arnet · I. · Roth · A. J. · Ronel · J. · Olliges · E. · Locher · C.
Introduction

Chronic non-cancer pain presents a global health problem, with a significant increase in opioid prescriptions over recent decades. However, opioid therapy poses risks of adverse events, overdose and non-medical use. As a result, many patients seek to discontinue or reduce their opioid intake. Strategies for opioid tapering often lack efficacy, prompting the investigation of novel approaches like open-label placebo (OLP), that is, the administration of a placebo with full disclosure that it is a placebo. OLP has shown efficacy in chronic non-cancer pain syndromes and has been suggested as a promising candidate for medication tapering. This study aims to assess whether OLPs can enhance the reduction of daily morphine equivalent dose (MED) in chronic non-cancer pain patients and examines its potential in mitigating opioid withdrawal symptoms.

Methods and analysis

This study is designed as a randomised, controlled, single-centre trial. Participants will be randomised into either an OLP group or a control group. The study duration will span six to nine weeks, during which all participants will aim to reduce their opioid intake. Both groups will monitor their opioid intake daily using a diary app and will receive feedback on their progress of reducing opioids. Additionally, participants in the OLP group will receive OLP tablets for the entire study period. During the first week, the OLP group will undergo a one week learning phase using a classical conditioning paradigm, where each opioid intake is paired with a placebo. In the subsequent five weeks, the OLP group will enter a dose-extension phase in which only the first opioid intake of the day is paired with a placebo, and additional placebos can be taken as desired. At the end of the study, qualitative interviews will be conducted with the first 15 participants in the OLP group. The primary outcome measure is daily opioid intake. Secondary outcomes include opioid withdrawal symptoms, pain severity, disability, anxiety, depression, opioid beliefs, intervention expectancy and qualitative data. Statistical analyses will include analysis of covariance and regression models.

Ethics and dissemination

The ethics committee of the Canton of Zurich, Switzerland, approved the study (SNCTP-nr.: SNCTP000005853/BASEC nr.: 2023–02327).

Participants will be compensated with 100 Swiss Francs for their full participation in the study. Participants who will take part in the qualitative interview will be compensated with additional 15 Swiss Francs.

Trial registration number

This study is registered at clinicaltrials.gov: NCT06350786.

Risk factors for neuroendocrine neoplasms: protocol for a case-control study based on a record linkage of registry and claims data

Por: Voigtländer · S. · Gerlach · R. · Grundmann · N. · Donnachie · E. · Berger · U. · Hakimhashemi · A. · Meyer · M. · Tauscher · M. · Müller-Nordhorn · J.
Background

Recent studies showed an increase in neuroendocrine neoplasms, especially for the digestive tract. Several risk factors have been suggested to explain this increase, including a family history of cancer, tobacco smoking, alcohol consumption and metabolic disorders such as diabetes and obesity. Another risk factor may be depressive disorders, which could increase the risk of neuroendocrine neoplasms either directly or mediated through associated risk behaviours and/or antidepressant medication. Here, we outline the design of our study to identify the risk factors for neuroendocrine neoplasms in Germany.

Methods and analysis

A case–control study of the resident population of Bavaria, the second most populous federal state in Germany, based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. Cases have a diagnosis of a malignant neuroendocrine neoplasm, either of the bronchopulmonary system or the gastroenteropancreatic system, in the period from 2021 to 2023. Controls are sampled from the non-cases and matched on sex, birth year (in 5-year intervals) and time of diagnosis (by calendar quarter). Risk factor prevalence of cases and controls is assessed on the basis of assured outpatient diagnoses, that is, diagnoses documented in at least 2 out of 4 consecutive quarters in the 16 quarters preceding the diagnosis of a neuroendocrine neoplasm. The analysis uses conditional logistic regression to estimate ORs and 95% CIs.

Ethics and dissemination

This study protocol was approved by the Ethics Committee of the Bavarian State Chamber of Physicians (reference number: 24008). Approval by the supervisory authority has been obtained from the Bavarian State Ministry of Health, Care, and Prevention (reference number: G35h-A1080-2023/20-2) and also the Bavarian Data Protection Commissioner stated to have no concerns after presentation of the study protocol (reference number: DSB/7-692/1-275). The results of the case–control study will be presented at national as well as international conferences and be published in the form of scientific articles in peer-reviewed journals.

Trial registration number

NCT06282016.

Primary care providers experience and satisfaction with personalised breast cancer screening risk communication: a descriptive cross-sectional study

Por: Omeranovic · A. · Lapointe · J. · Fortier · P. · Bergeron · A.-S. · Dorval · M. · Chiquette · J. · Boubaker · A. · Eloy · L. · Turgeon · A. · Lambert-Cote · L. · Joly · Y. · Brooks · J. D. · Walker · M. J. · Stockley · T. · Pashayan · N. · Antoniou · A. · Easton · D. · Chiarelli · A. M.
Objective

To describe primary care providers’ (PCPs) experience and satisfaction with receiving risk communication documents on their patient’s breast cancer (BC) risk assessment and proposed screening action plan.

Design

Descriptive cross-sectional study.

Setting

A survey was distributed to all 763 PCPs linked to 1642 women participating in the Personalized Risk Assessment for Prevention and Early Detection of Breast Cancer: Integration and Implementation (PERSPECTIVE I&I) research project in Quebec, approximately 1–4 months after the delivery of the risk communication documents. The recruitment phase took place from July 2021 to July 2022.

Participants

PCPs.

Main outcome measures

Descriptive analyses were conducted to report participants’ experiences and satisfaction with receiving risk communication. Responses to two open-ended questions were subjected to content analysis.

Results

A total of 168 PCPs answered the survey, from which 73% reported being women and 74% having more than 15 years of practice. Only 38% were familiar with the risk-based BC screening approach prior to receiving their patient risk category. A majority (86%) agreed with the screening approach and would recommend it to their patients if implemented at the population level. A majority of PCPs also reported understanding the information provided (92%) and expressed agreement with the proposed BC screening action plan (89%). Some PCPs recommended simplifying the materials, acknowledging the potential increase in workload and emphasising the need for careful planning of professional training efforts.

Conclusion

PCPs expressed positive attitudes towards a risk-based BC screening approach and were generally satisfied with the information provided. This study suggests that, if introduced in Canada in a manner similar to the PERSPECTIVE I&I project, risk-based BC screening would likely be supported by most PCPs. However, they emphasised the importance of addressing concerns such as professional training and the potential impact on workload if the approach were to be implemented at the population level. Future qualitative studies are needed to further explore the training needs of PCPs and to develop strategies for integrating this approach with the high workloads faced by PCPs.

Characterizing suicidal thoughts and behaviours in individuals presenting to a psychiatric emergency department: a protocol for a multimethod approach for suicide prevention research

Por: Baharikhoob · P. · Maslej · M. · Wong · A. H. C. · Mulsant · B. · Blumberger · D. · Courtney · D. · Husain · M. I. · Kurdyak · P. · Kleinman · R. A. · Torfason · A. · Gajaria · A. · Diaconescu · A. · Ma · A. · Sonley · A. · Abramovich · A. · Crawford · A. · Petronis · A. · Fage · B. · Orch
Introduction

Identifying individuals at risk of suicide remains an ongoing challenge. Previous research investigating risk factors for suicidal thoughts and behaviours (STB) has been informative for assessing suicide risk. However, the complex biological, psychological and sociocultural factors underlying STB have not been comprehensively captured to date, which has limited our understanding of how these factors interact to influence STB. Moreover, acute care settings, such as emergency departments (EDs), are often first points of contact for individuals with STB, highlighting a need for more research in these settings.

Methods and analysis

We aim to (1) characterize a cohort seeking care for STB and their clinical trajectories; (2) situate the cohort by comparing its characteristics and outcomes to other groups seeking emergency care; (3) explore their experiences of seeking care; and (4) examine blood-based biomarkers modulating risk for STB. Using a multimethod, prospective cohort design, we will follow up to 500 people aged 16 or older presenting to the ED with STB at a psychiatric hospital over 1 year. Analyses will involve descriptive statistics and latent profile analysis to characterize the cohort, hypothesis tests and regression models to situate the cohort, qualitative analysis based on a realist research framework to understand experiences, and within-participant comparisons of proteins, mRNA and epigenetic DNA modifications to examine biomarkers of contrasting states of STB.

Ethics and dissemination

This study was approved by the hospital’s Research Ethics Board with safeguards in place to ensure the well-being of participants and research team. An integrated knowledge translation approach will be used for dissemination, wherein patient and family advisors are engaged throughout each study phase. Findings will enhance our understanding of the multifactorial nature of suicide risk, inform strategies for prevention and provide important insights into characteristics, experiences and outcomes of individuals with STB, who are under-represented in mental health research.

SMALL: open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer--protocol for a phase III randomised multicentre trial

Por: Elder · K. · Coles · C. · Dodwell · D. · Elsberger · B. · Foster · J. · Gaunt · C. · Henderson · J. R. · Lyburn · I. · Mabena · C. · Morgan · J. · Nabi · Z. · Paramasivan · S. · Pinder · S. · Pirrie · S. · Potter · S. · Roberts · T. · Sharma · N. · Southgate · E. · Stobart · H. · Talwalkar
Introduction

Mammographic screening identifies many women with small breast cancers with favourable biological features, which have an excellent prognosis. Some of these may never have become clinically apparent without screening and are commonly described as ‘overdiagnosed’ cancers. Despite this, all patients with screen-detected cancers are currently treated with surgical excision and sentinel lymph node biopsy, although this may represent overtreatment. There is, therefore, a need for less invasive approaches to reduce treatment burden for patients while maintaining current excellent oncological outcomes. Vacuum-assisted excision (VAE) may represent such an alternative treatment approach, and the SMALL (Open Surgery versus Minimally invasive-vacuum Assisted excision for smaLL screen-detected breast cancer) trial aims to investigate the use of VAE for the safe de-escalation of surgical treatment for such excellent prognosis invasive breast cancers.

Methods

SMALL is a prospective, multicentre, randomised phase III trial of VAE versus surgery in patients with small, biologically favourable screen-detected invasive breast cancer. SMALL has an innovative hybrid design with coprimary endpoints. These include a randomised non-inferiority comparison of surgical re-excision rates following initial treatment, and a single-arm analysis of local recurrence at 5 years following VAE. Secondary outcomes include complication rates, overall survival, quality of life and a health economic analysis. The trial includes a QuinteT Recruitment Intervention to support recruitment.

Ethics and dissemination

Ethical approval was obtained from the Office for Research Ethics (Northern Ireland) for all UK sites. Results will be submitted for publication in a peer-reviewed journal, presented, shared with patient partners and with relevant professional organisations to inform future guideline development for the management of screen-detected breast cancer.

Trial registration number

ISRCTN12240119.

Prognostic factors of disability progression in multiple sclerosis in real life: the OFSEP-high definition (OFSEP-HD) prospective cohort in France

Por: Francis · G. · Romain · C. · Jonathan · E. · Yohann · F. · David · L. · Hamza · A. · Fabien · R. · Emmanuelle · L. · Sandra · V. · OFSEP-HD investigators · BERGER · BRANGER · CABRE · CASEZ · CIRON · CLAVELOU · CREANGE · SEZE · DOGHRI · SANTOS · EDAN · HEINZLEF · LABAUGE · LAPLAUD · LEBR
Purpose

To determine prognostic factors of disability in multiple sclerosis (MS), that is, (1) identify determinants of the dynamics of disability progression; (2) study the effectiveness of disease-modifying treatments (DMTs); (3) merge determinants and DMTs for creating patient-centred prognostic tools and (4) conduct an economic analysis.

Participants

Individuals registered in the French Observatoire Francais de la Sclérose en Plaques (OFSEP) database were included in this OFSEP-high definition cohort if they had a diagnosis of MS, were ≥15 years old and had an Expanded Disability Status Scale (EDSS) score

Findings to date

A cohort of 2842 individuals, 73.4% women, mean (SD) age of 42.7 (11.6) years, median disease duration of 8.8 years, has been recruited from July 2018 to September 2020. The course of MS was relapsing remitting in 67.7%, secondary progressive in 11.9%. The mean annual relapse rate was 0.98. The disease-modifying treatment received was highly effective therapy in 50.3% and moderately effective therapy in 30.7%.

Future plans

The participants will be followed until December 2026. Disease course up to four landmarks will be examined as predictors of disease progression: (1) diagnosis of MS; (2) relapse activity worsening and independent progression; (3) any recent disease activity and (4) any visit with absence of disease activity in the past 5 years. The marginal effectiveness and tolerability of treatments will be assessed. Stratified algorithms will be proposed for medical decision-making. Economic evaluation of disease cost and cost-effectiveness of new DMTs will be conducted from a public payer perspective.

Trial registration number

NCT03603457.

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