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Bipolar disorder affects around 2% of the population and is linked with reduced life expectancy and socioeconomic burden. Depressive episodes are difficult to treat and typically more prevalent, enduring and burdensome than manic episodes. The use of antidepressants alone has limited effect and is associated with significant clinical risk through polarity switch. Current National Institute for Health and Care Excellence guidelines recommend quetiapine, olanzapine (with or without fluoxetine) and lamotrigine; however, these medications have limited efficacy, tolerability and acceptability. The ASCEnD study aims to assess the clinical and cost-effectiveness of aripiprazole plus sertraline compared with quetiapine, offering potential improvements for outcomes in bipolar depression. The study is funded by the National Institute for Health and Care Research Health Technology Assessment programme (NIHR132773).
ASCEnD is a prospective, two-arm, superiority, individually 1:1 randomised, controlled, pragmatic, parallel group, type A open-label clinical trial of aripiprazole/sertraline medication combination compared with quetiapine for bipolar depression. The study is conducted in the UK National Health Service setting with the aim of recruiting and randomising 270 participants followed-up for 24 weeks. Adults with bipolar disorder self-refer or are recruited through primary and secondary care services. The primary outcome is change in depressive symptoms 12–16 weeks after randomisation. Secondary outcomes include measures of symptom change, treatment satisfaction, tolerability, medication adherence, concomitant medication use, psychosocial functioning, quality of life and cost-effectiveness and informal carer measures of quality of life and costs of caring. The exploratory outcome is change in participant reward and punishment responsiveness. Analysis will follow a prespecified statistical analysis plan. A nested qualitative study is included to examine feasibility and acceptability of the trial design.
A Clinical Trial Authorisation from Medicines and Healthcare products Regulatory Agency, and approval from the Health Research Authority (IRAS 1007468) and North East – Newcastle and North Tyneside 1 Research Ethics Committee (23/NE/0132) were obtained. Results will be disseminated through peer-reviewed publications, conference presentations and lay summaries for participants and patient and public groups.
To establish consensus definitions for non-visually impairing eye conditions (NVICs) and their methods of assessments to provide standards for use in population-based eye surveys.
A literature review of NVICs in sub-Saharan Africa, a questionnaire of inquiry based on the literature review developed by an expert panel and a modified Delphi exercise with three iterative rounds with eye health experts.
Eye health academia and community eye health in Nigeria.
Nigerian ophthalmologists, including subspecialists experienced in population-based eye health surveys.
Definitions and statements where at least 70% of the respondents agreed or strongly agreed.
Forty-two ophthalmologists practising in Nigeria with experience in conducting population-based eye health surveys were invited to take part in the Delphi exercise. There were three rounds with response rates of 39/42 (92.9%) in round 1, (94.9%) in round 2 and 100% in round 3. Consensus for NVICs to be included in population-based eye surveys, their definitions and methods for assessment was reached by the third round.
We propose case definitions for NVICs to be assessed in population-based eye surveys through a modified Delphi approach with an expert panel of ophthalmologists from across Nigeria. These case definitions will allow for standardisation of NVICs in population-based eye surveys to assess the prevalence and magnitude of the different types of NVICs for planning purposes. Further studies are needed to validate these case definitions and inform their evolution.
by Claire L. Chan, Saskia Eddy, Jennie Hejdenberg, Ben Morgan, Heather M. Morgan, Gillian Lancaster, Clare Robinson, Sandra M. Eldridge
BackgroundThe National Institute for Health and Care Research accepts applications for pilot and feasibility studies to their Research for Patient Benefit (RfPB) programme. There has been limited work describing the design practices of these applications and funding status. Knowing some of the qualities which may contribute towards a pilot or feasibility study application successfully gaining funding could help researchers improve the quality of their applications. Therefore, this study describes the protocol for a review looking at the characteristics of funded and non-funded external pilot trial applications. In particular, the primary objective is to describe the planned sample size and sample size justifications.
MethodsThe study will be conducted on 100 applications from Competition 31–37 with a randomised feasibility design, identified and given access to us by RfPB where the lead applicant has consented. We will screen these applications to identify the external pilot trials, first looking through the titles and then the full text. Following this, we will extract data on information such as medical area, study design, objective(s), sample size, sample size justification, and funding outcome stage one and two. Validation will be performed on 20% of the data extracted; discrepancies will be resolved by discussion or a third reviewer will decide if there is no consensus. We will use descriptive statistics to summarise quantitative data, and will analyse qualitative data using thematic analysis. Findings will be summarised through discussion with the project contributors to produce a reader-friendly guidance document.
DiscussionThis work will provide a more complete picture of RfPB external randomised pilot and feasibility trials. The findings will assist researchers when planning their pilot trials, and could help improve the quality of submitted applications.
Protocol RegistrationOpen Science Framework protocol registration DOI: https://doi.org/10.17605/OSF.IO/PYKVG.
The rise in smartphone use presents opportunities and challenges in clinical settings. Despite guidelines restricting mobile phone use, nurses frequently rely on them for various purposes. While beneficial, smartphone use poses risks to information security, patient safety, and care quality, prompting the need for monitoring.
This study examined smartphone usage among nursing students and their perspectives on acceptable and unacceptable use during clinical placements.
This cross-sectional study used convenience sampling to recruit undergraduate nursing students from five universities in Australia and New Zealand. Participants completed the Attitude Towards Digital Device Use during Clinical Placement (Adduct) Scale online between September 2021 and August 2022. The survey included closed and open-ended questions. Descriptive and inferential analyses were conducted using SPSS. Exploratory factor analysis identified attitudinal dimensions, while group comparisons assessed demographic variations. Qualitative responses were thematically analysed. Reporting followed the Consensus-Based Checklist for Reporting of Survey Studies (CROSS).
Among 279 respondents, drawn from an eligible population of 2682 students, the response rate was 10.4%. Age significantly influenced perceptions of unacceptable smartphone use. Younger students (mean age = 25.0, SD = 9.8) were more likely to view such use as acceptable, with those up to 21 years reporting higher scores on the Unacceptable Use sub-scale compared to older peers (p = 0.024). Most respondents found smartphone use beneficial for accessing information and learning, though concerns included distractions and confidentiality breaches. Younger students were at greater risk of non-adherence to guidelines.
Smartphones can enhance learning and efficiency, but clear guidelines and education are needed to balance benefits with risks, particularly for younger students.
This study highlights the need for clear guidelines and structured training to balance educational benefits of smartphone use with the risks of distraction and breaches of patient confidentiality in clinical practice.
No patient or public pontribution.
To explore women's experience of the period after completion of cancer treatment for gestational trophoblastic neoplasia (GTN): a descriptive exploratory study.
A descriptive exploratory qualitative study.
Women diagnosed with the rare pregnancy-related cancer GTN who had completed their treatment participated in semi-structured telephone interviews. Twenty-two interviews were conducted in June 2024 and digitally recorded and transcribed verbatim. The analysis used reflective thematic analysis.
Complex responses to treatment completion were revealed, described by some as a ‘double-edged sword’. The end of treatment routine, coupled with recovery from physical effects, left space for the impact of all they had experienced to ‘hit home’. Multiple concerns and losses were described, including issues relating to pregnancy, self-identity, confidence, fear of recurrence, work and relationships. Gaps in immediate post-treatment support services created challenges for recovery.
The study provides valuable insight into the physical, emotional and social impact of GTN experienced by patients following treatment. The findings highlight the importance of continuing support in the immediate post-treatment period. This study has identified ways in which services can be improved, recognising the need for an individual-tailored approach to reflect the complex responses of patients to treatment completion.
The findings reveal that many women begin to process the implications of their diagnosis and treatment following the completion of their treatment. The end of treatment can be a time when support from healthcare staff is reduced due to fewer routine contacts with healthcare staff. However, these findings suggest the need for nurses to ensure services continue to provide support during the post-treatment recovery phase.
The interview schedule was reviewed by women previously treated for GTN.
by Annyi Tatiana Belalcazar, Valeria Monroy Lasso, José Darío Álvarez Herazo, Ana Clarete, Roger Figueroa-Paz, Duban Maya-Portillo, Julio Diez-Sepúlveda
BackgroundThe Shock Index (SI) is a validated prognostic tool in conditions such as severe trauma and obstetric hemorrhage. During the COVID-19 pandemic, it was used to identify patients at higher risk of clinical deterioration, but results have been inconsistent. This study aimed to evaluate the prognostic value of the SI and its variants in predicting mortality, need for mechanical ventilation, and hospital length of stay in patients with moderate COVID-19.
Methods and findingsThis longitudinal analytical observational study was conducted at a high-complexity hospital in southwestern Colombia and included adults over 18 years of age with moderate COVID-19 treated between 2020 and 2022, using data from the institutional RECOVID registry. A total of 283 patients were analyzed (median age: 61 years; 58.7% male), with cardiovascular and renal comorbidities being predominant. On admission, vital signs were stable (NEWS2: 3.0; shock index: 0.7). ICU admission was required in 29.3% of cases, and overall mortality was 12%. ROC curves and diagnostic accuracy parameters were used to assess the discriminatory ability of the SI and its variants. Most SI variants showed low discriminatory power (AUC Conclusions
Early identification of patients at risk for complications in moderate COVID-19 is essential for optimizing hospital resources. The shock index and its variants showed limited utility as standalone predictors for mortality, ICU admission, and hospital length of stay. Combining SI with other clinical parameters may offer some benefit, but heterogeneity limits generalizability. Future studies should develop and prospectively validate multivariable models integrating clinical, laboratory, and imaging biomarkers.
To examine the concept of midwifery agency when using Maternity Early Warning Tools.
Concept analysis using Rogers' evolutionary method.
Data were collected from interviews with midwives working in various Australian maternity settings. A subset of the dataset was collected and analysed (2021–2022) to examine how agency functions when midwives use Maternity Early Warning Tools.
Three conceptual attributes fundamental to agency were identified: considered judgement, reasoned clinical decision-making, and collaborative action. These attributes reveal how midwives navigate the interface between structured risk management tools and relational, woman-centred care.
Maternity Early Warning Tools can either limit or enhance professional agency. When used reflexively, they become artefacts that support learning, communication, and sound clinical judgement. Viewing these tools as enablers rather than enforcers sustains midwifery expertise and strengthens interdisciplinary collaboration.
Sustaining midwifery agency protects both professional integrity and the quality of woman-centred care.
What problem did the study address? How the use of Maternity Early Warning Tools influences midwives' agency.
Type 2 diabetes mellitus (T2D) and metabolic syndrome (MetS) have reached epidemic proportions for Indigenous populations globally. In Australia, disproportionate rates of T2D and MetS are inextricably tied to the experience of colonisation. As part of a growing shift towards strengths-based, Aboriginal-led initiatives, this project sought to co-design and assess the feasibility of a metabolic remission initiative, whereby Aboriginal people living on Ngarrindjeri Ruwe (Country) are supported to adopt a low-carbohydrate diet.
This 28-week pilot takes the form of a non-randomised stepped-wedge design. Aboriginal adults (≥18 years) living on Ngarrindjeri Ruwe with T2D or MetS will be recruited to two sites in rural South Australia. Participants will transition through three phases (control phase, remission phase and maintenance phase) with repeated measures taken across five key time points (T1–T5). While centring on the adoption of a low-carbohydrate diet, participants will be equipped with continuous glucose and ketone monitors and meal boxes and offered ongoing support through weekly to fortnightly check-ins. The primary outcome is to assess the feasibility of Nra:gi Ya:yun in preparation for a large-scale clinical trial of similar design. Feasibility will be assessed through recruitment, retention and adherence rates. Self-reported dietary recall, out-of-pocket food costs and national pharmaceutical and medical benefits scheme data will also be examined. Qualitative data obtained using the Aboriginal research method of yarning will aid analysis and interpretation of results. Clinical measures (such as blood pressure, weight, waist circumference, capillary ketones and capillary glucose) and venous blood draws will assist in the evaluation of our secondary outcome, namely the initiatives’ preliminary effect on participant metabolic health.
Findings will be disseminated to Community, participants and policymakers in the form of digital posters, manuals, infographics and peer-reviewed publications. Lessons from this study have the potential to provide insights and benefits to Australian public health policy and research, as well as Indigenous populations globally who face similar metabolic challenges. Findings will be used to advise on an implementation strategy for a large-scale clinical trial. Pilot trial approved by the Aboriginal Health Research Ethics Committee (HREC), Flinders University HREC and Southern Adelaide Local Health Network HREC.
Pilot prospectively registered with the Australian and New Zealand Clinical Trials Registry ACTRN12624001019594.
Commentary on: Wilson, A., Hurley, J., Hutchinson, M., & Lakeman, R. (2023). In their own words: Mental health nurses’ experiences of trauma-informed care in acute mental health settings or hospitals. International Journal of Mental Health Nursing. doi.org/10.1111/inm.13280
Trauma-informed care (TIC) in acute mental healthcare settings is inhibited by mental health nurses’ experiences of being unsafe, their lack of emotion management skills and their involvement in coercive practices. Further research is needed to better understand the relationship between mental health nurses’ emotional intelligence and their ability to implement TIC.
TIC is an approach that has emerged from recognition of the prevalence of psychological trauma.
El presente trabajo tiene como finalidad determinar la producción científica sobre lactancia materna, con una muestra de artículos publicados en revistas españolas sanitarias entre los años 1980 y 2015, seleccionadas en las bases de datos Cuiden Citation 2015 y Google Scholar Metrics. Un análisis bibliométrico a través de indicadores de productividad, colaboración y obsolescencia. Se han analizado 113 artículos, identificándose 387 autores con un índice de productividad mayor que 0 y menor que 1, una media de 3.6 autores por artículo. La autora más productiva, Pallás Alonso, C.R., los hospitales clínico universitario Lozano Blesa, universitario 12 de Octubre y Universidad de Zaragoza, las instituciones más prolíficas. Encontrándose 1998 el año más productivo, predominando entre todos los artículos analizados los de metodología descriptiva, con una colaboración internacional del 2%. Se considera preciso aumentar la colaboración internacional entre instituciones, así como, el aumento de estudios de metodología analítica o intervención.
FreshRSS 