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Development of a Core Outcome Set for Dysphagia Interventions in Parkinsons disease (COS-DIP): study protocol

Por: Hirschwald · J. · Duncan · S. · Warnecke · T. · Boyle · G. · Regan · J. · Walshe · M.
Introduction

Current clinical trials on swallowing disorders (dysphagia) in Parkinson’s disease (PD) apply a high variety of outcomes and different outcome measures making comparative effectiveness research challenging. Furthermore, views of patients and dysphagia clinicians when selecting trial outcomes have not been considered in the past, thus study results may have little importance to them. This study aims to develop an agreed standardised Core Outcome Set for Dysphagia Interventions in Parkinson’s disease (COS-DIP), systematically measured and reported as a minimum for all clinical trials. It will also comprise guidance on outcome definitions, outcome measures and time points of measurement.

Methods and analysis

The COS-DIP development will comprise five stages following established methodology: (1) a recent scoping review on all applied outcomes, their definitions, methods and time points of measurement in clinical trials in dysphagia in PD, (2) online surveys and focus groups with clinicians, patients, caregivers and family members to identify outcomes that are important to them, (3) an identified list of outcomes based on results of stage 1 and 2, (4) three round online Delphi survey with up to 200 key stakeholders to determine core outcomes and (5) two online consensus meetings with up to 40 representative key stakeholders to agree on all outcomes, definitions, methods and time points of measurement in the final COS-DIP.

Ethics and dissemination

Full ethical approval was obtained from the Research Ethics Committee, School of Linguistic, Speech and Communication Sciences, Trinity College Dublin, on 15 May 2023 (HT27). Dissemination of the COS-DIP will be enhanced through presentations at (inter-) national conferences and through peer-reviewed, open access publications of related manuscripts. Lay and professional information sheets and infographics will be circulated through relevant patient and professional organisations and networks.

Trial registration number

The COS-DIP study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database on 24 September 2021 (www.comet-initiative.org/Studies/Details/1942).

Burden of diabetic ketoacidosis among patients with diabetes mellitus in Ethiopia: a systematic review and meta-analysis

Por: Abera · E. G. · Yesho · D. H. · Erega · F. T. · Adulo · Z. A. · Gebreselasse · M. Z. · Gebremichael · E. H.
Objectives

This systematic review and meta-analysis aimed to assess the magnitude and determinants of diabetic ketoacidosis (DKA) among patients with diabetes mellitus (DM) in Ethiopia.

Design

Systematic review and meta-analysis.

Participants

Age 15 and above all patients with diabetes with the diagnosis of DKA in Ethiopia

Data source

PubMed/MEDLINE, Cochrane Library, Science Direct, HINARI, Google Scholar and grey literatures were accessed to find relevant articles. Studies that have been conducted and reported in English language, articles with an available full-text, and observational studies were included. The task of searching sources was carried out from all stated electronic databases performed during 15 April–29 April 2023.

Primary and secondary outcome measures

Eligible studies were critically appraised by three independent reviewers for methodological quality in the review using standardised critical appraisal instruments from Joanna Briggs Institute (JBI) for observational studies. After the finally extracted studies were exported, systematic review and meta-analysis were conducted using Unified Management, Assessment and Review of Information (JBI SUMARI) (JBI, Adelaide, Australia) and STATA V.17 software. Sensitivity tests were done, and funnel plot inspections with Egger’s test were used to check for publication bias.

Result

From a total of 19 studies with 6498 study participants, the pooled prevalence of DKA among patients with DM in Ethiopia was 30.92% (95% CI 29.96 to 31.89) with a significant statistical heterogeneity (I2=99.2, p=

Conclusion

This systematic review and meta-analysis revealed that the prevalence of DKA among patients with DM in Ethiopia was 30.92%. Besides, different behavioural and clinical determinants of DKA among patients with DM were identified. However, further studies should be conducted, particularly on the possible determinants of DKA, and different stakeholders should be engaged to minimise its burden.

Is reduced heart rate variability associated with functional somatic disorders? A cross-sectional population-based study; DanFunD

Por: Jorgensen · T. · Dantoft · T. M. · Petersen · M. W. · Gormsen · L. · Winter-Jensen · M. · Fink · P. · Linneberg · A. · Benros · M. E. · Eplov · L. F. · Bjerregaard · A. A. · Schovsbo · S. U. · Brinth · L. S.
Objectives

It has been hypothesised that functional somatic disorders (FSD) could be initiated by sympathetic predominance in the autonomic nervous system as measured by low heart rate variability (HRV). Earlier studies on the association between HRV and FSD are small case–control studies hampered by selection bias and do not consider the great overlap between the various FSDs. The aim of the present study is to assess any associations between HRV and various FSDs and whether chronic stress confounds such an association.

Design

A cross-sectional general population-based study.

Setting

The Danish Study of Functional Somatic Disorders conducted 2013–2015 in 10 municipalities in the western part of Greater Copenhagen, Denmark.

Participants

A total of 6891 men and women aged 18–72 years were included in the analyses after exclusion of 602 persons with missing HRV data. Various delimitations of FSD (chronic fatigue, chronic widespread pain, irritable bowel and bodily distress syndrome) were identified by validated questionnaires and diagnostic interviews. HRV parameters in time and frequency domains were calculated from successive beat-to-beat heart rate (HR) data using the ‘E-motion’ HR monitor device during 7 min of supine rest. Chronic stress was assessed by Cohen’s self-perceived stress scale.

Outcome measures

Logistic regression analyses were used to calculate possible associations between the various delimitations of FSD and HRV adjusting for chronic stress.

Results

Persons with FSD had a slightly higher mean HR and lower HRV as measured by time domain parameters, whereas associations with frequency domain parameters were not consistent. Adjusting for chronic stress attenuated associations slightly.

Conclusion

The study supports a sympathetic predominance in persons with FSD, which could not be entirely explained by chronic stress. However, it is not possible to conclude whether the association is a causal factor to or a consequence of FSD.

The influence of supportive work environment on work‐related stress and conflict management style among emergency care nurses: A descriptive correlational study

Abstract

Background

Stress and conflict in emergency departments are inevitable but can be managed. A supportive work environment is key to helping emergency care providers, especially nurses, constructively manage work-related stress and conflict.

Aim

The aim of this study was to assess the influence of supportive work environments on work-related stress and conflict management style among emergency care nurses.

Methods

A descriptive correlational research design was utilized. Data were collected from 221 staff nurses recruited from two university hospital emergency departments in Alexandria, Egypt. Three instruments were used: (1) perceived organizational support scale, (2) nurses' occupational stressors scale, and (3) conflict management style inventory.

Results

There was a highly significant correlation between supportive work environments and work-related stress (p = .000) and a significant correlation between supportive work environments and conflict management style (p = .026). Supportive work environments had a significant inverse negative relationship with work-related stress experienced by nurses (p = .001) and accounted for 51% of variance in work-related stress. Meanwhile, supportive work environments had a significant positive relationship with conflict management styles of nurses (p = .026). Work-related stress had a significant relationship with nurses' conflict management style (p = .000) and accounted for 45% of the variance in conflict management style.

Linking Evidence to Action

The style of conflict management modeled by staff within emergency departments can positively or negatively influence the work environment and level of work-related stress. There is a necessity to cultivate a supportive culture for nurses in emergency departments to develop skills for constructive conflict management styles to reduce work-related stress.

How does subjective social status at school at the age of 15 affect the risk of depressive symptoms at the ages of 18, 21, and 28? A longitudinal study

by Marie Kjærgaard Lange, Vivi Just-Nørregaard, Trine Nøhr Winding

Background

Young people’s mental health is declining. Depression is a public disease which is increasing internationally, and in Denmark an increase is seen especially among young people. Objective social status is known to be associated with mental health and depression, but little is known about the association between adolescent subjective social status at school and depressive symptoms during young adulthood. The aim was to investigate the association between 15-year-old’s subjective social status at school and the development of depressive symptoms at age 18, 21 and 28.

Methods

The study is a longitudinal study using questionnaire data from The West Jutland Cohort Study Denmark. The study population consisted of adolescents who at baseline, at age 15 (2004), had answered questions about their subjective social status in school using the MacArthur scale-youth version. Answers were categorised into low, medium, and high subjective social status. Outcome data about depressive symptoms was collected at age 18 (2007), age 21 (2010) and age 28 (2017) using the CES-DC and CES-D scales, dichotomised into few or many depressive symptoms. The associations between subjective social status at school at age 15 and depressive symptoms at ages 18, 21 and 28 were analysed using multiple logistic regression.

Results

Statistically significant associations were found between low subjective social status at school at age 15 and the odds of many depressive symptoms at all three age points in young adulthood. When adjusting for co-variates the odds ratio for many depressive symptoms at age 18 was OR 3.34 [1.84;6.08], at age 21 OR 3.31 [1.75;6.26] and at age 28 OR 2.12 [1.13;3.97].

Conclusions

The subjective social status of 15-year-olds is associated with depressive symptoms at ages 18, 21 and 28, respectively. It seems that subjective social status at age 15 is of greatest importance for the occurrence of depressive symptoms in the short run, and that the impact attenuates over time.

Non-ischaemic preservation of the donor heart in heart transplantation: protocol design and rationale for a randomised, controlled, multicentre clinical trial across eight European countries

Por: Brouckaert · J. · Dellgren · G. · Wallinder · A. · Rega · F.
Introduction

Ischaemic cold static storage (ICSS) is the gold standard in donor heart preservation. This ischaemic time frame renders a time constraint and risk for primary graft dysfunction. Cold oxygenated heart perfusion, known as non-ischaemic heart preservation (NIHP), theoretically limits the ischaemic time, while holding on to the known advantage of hypothermia and cardioplegia, a low metabolic rate.

Methods and analysis

The NIHP 2019 study is an international, randomised, controlled, open, multicentre clinical trial in 15 heart transplantation centres in 8 European countries and includes 202 patients undergoing heart transplantation, allocated 1:1 to NIHP or ICSS. Enrolment is estimated to be 30 months after study initiation. The patients are followed for 12 months after transplantation.

The primary objective is to evaluate the effect of NIHP on survival, allograft function and rejection episodes within the first 30 days after transplantation. The secondary objectives are to compare treatment groups with respect to survival, allograft function, cardiac biomarkers, rejection episodes, allograft vasculopathy, adverse events and adverse device effects within 12 months.

Ethics and dissemination

This protocol was approved by the Ethics Committee (EC) for Research UZ/KU Leuven, Belgium, the coordinating EC in Germany (Bei Der LMU München), the coordinating EC in the UK (West Midlands—South Birmingham Research), the EC of Hospital Puerta de Hierro, Madrid, Spain, the EC of Göteborg, Sweden, the coordinating EC in France, the EC of Padova, Italy and the EC of the University of Vienna, Austria. This study will be conducted in accordance with current local regulations and international applicable regulatory requirements according to the principles of the Declaration of Helsinki and ISO14155:2020. Main primary and secondary outcomes will be published on modified intention-to-treat population and per-protocol population.

Trial registration number

NCT03991923.

The important factors nurses consider when choosing shift patterns: A cross‐sectional study

Abstract

Aim

To gain a deeper understanding of what is important to nurses when thinking about shift patterns and the organisation of working time.

Design

A cross-sectional survey of nursing staff working across the UK and Ireland collected quantitative and qualitative responses.

Methods

We recruited from two National Health Service Trusts and through an open call via trade union membership, online/print nursing profession magazines and social media. Worked versus preferred shift length/pattern, satisfaction and choice over shift patterns and nurses' views on aspects related to work and life (when working short, long, rotating shifts) were analysed with comparisons of proportions of agreement and crosstabulation. Qualitative responses on important factors related to shift preferences were analysed with inductive thematic analysis.

Results

Eight hundred and seventy-three survey responses were collected. When nurses worked long shifts and rotating shifts, lower proportions reported being satisfied with their shifts and working their preferred shift length and pattern. Limited advantages were realised when comparing different shift types; however, respondents more frequently associated ‘low travel costs’ and ‘better ability to do paid overtime’ with long shifts and ‘healthy diet/exercise’ with short shifts; aspects related to rotating shifts often had the lowest proportions of agreement. In the qualitative analysis, three themes were developed: ‘When I want to work’, ‘Impacts to my life outside work’ and ‘Improving my work environment’. Reasons for nurses' shift preferences were frequently related to nurses' priorities outside of work, highlighting the importance of organising schedules that support a good work-life balance.

Relevance to Clinical Practice

General scheduling practices like adhering to existing shift work guidelines, using consistent and predictable shift patterns and facilitating flexibility over working time were identified by nurses as enablers for their preferences and priorities. These practices warrant meaningful consideration when establishing safe and efficient nurse rosters.

Patient or Public Contribution

This survey was developed and tested with a diverse group of stakeholders, including nursing staff, patients, union leads and ward managers.

Reporting Method

The Strengthening the Reporting of Observational Studies (STROBE) checklist for cross-sectional studies was used to guide reporting.

Work-related stress and associated factors among health professionals working in Ambo town public health facilities, West Shoa Zone, Ethiopia, 2021: a cross-sectional study

Por: Bakare · M. · Darega · J. · Nugus · G. G. · Tsegaw · M.
Objectives

To assess work-related stress (WRS) and associated factors among health professionals working in Ambo town governmental health facilities, in 2021.

Design

Institution-based analytical cross-sectional study.

Setting

Institution-based analytical cross-sectional study was conducted in Ambo town from 15 July 2021 to 15 August 2021. A simple random sampling technique was used to select 420 participants. Data were collected by using structured self-administered questionnaire. Descriptive statistics was used to show the magnitude of WRS. Multivariate logistic regression was employed to identify variables that are significantly associated with WRS at 95% CI and p value

Participants

A total of 407 participants were involved in the study making the response rate 96.9%. The age of the respondents ranged from 20 to 52 with the mean age of 29 years (SD=4.8). Among all participants, 261 (64.1%) were male health professionals.

Results

This study found that the overall prevalence of WRS was 52.33% (47.5, 57.2). Being female (adjusted OR (AOR)=1.73, 95% CI 1.06, 2.81), home-work interface (AOR=1.93, 95% CI 1.19, 3.14), job insecurity (tendency not knowing continue current job (AOR=3.22, 95% CI 1.87, 5.56) and major life events (serious injury to close relatives (AOR=3.13, 95% CI 1.68, 5.84), death of close relative (AOR=2.09, 95% CI 1.16, 3.77), being violated by other (AOR=3.10, 95% CI 1.65, 5.83) and anything else seriously upset (AOR=2.63, 95% CI 1.60, 4.32) were factors significantly associated with WRS.

Conclusion

The prevalence of WRS among health professionals working in Ambo town public health facilities was high as compared with other studies. Sex, job insecurity, home-work interface and occurrence of major life events were factors that positively related to WRS and make the work of health professionals stressful. Health facilities, programme managers and policy makers should consider those identified factors while designing public health interventions to reduce WRS among health professionals.

Shaping care home COVID-19 testing policy: a protocol for a pragmatic cluster randomised controlled trial of asymptomatic testing compared with standard care in care home staff (VIVALDI-CT)

Por: Adams · N. · Stirrup · O. · Blackstone · J. · Krutikov · M. · Cassell · J. A. · Cadar · D. · Henderson · C. · Knapp · M. · Gosce · L. · Leiser · R. · Regan · M. · Cullen-Stephenson · I. · Fenner · R. · Verma · A. · Gordon · A. · Hopkins · S. · Copas · A. · Freemantle · N. · Flowers · P. · Sh
Introduction

Care home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes.

Methods and analysis

The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.

The trial will be delivered by a multidisciplinary research team through a series of five work packages.

The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers.

Ethics and dissemination

The study has been approved by the London—Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants.

Trial registration number

ISRCTN13296529.

A survey of Indonesian nurses' educational experiences and self‐perceived capability to care for people with intellectual disability and/or autism spectrum disorder

Abstract

Aims

To describe Indonesian nurses' educational experience regarding care for people with intellectual disability and/or autism and to explore if these educational experiences are associated with their self-perceived confidence, comfort, knowledge and preparedness to care for these cohorts.

Design

Cross-sectional descriptive survey.

Methods

A descriptive survey tool utilized in a study of Australian registered nurses was replicated and adapted for this study. Following descriptive analysis, chi-square analyses were undertaken to explore associations between educational experiences, and self-rated measures of confidence, comfort and knowledge to work with people with intellectual disability and/or autism. Although there was no end-user involvement in the design of the study, the concepts explored have all been raised by those with lived insights of intellectual disability and/or autism as being critical to their healthcare experiences.

Results

There were 544 complete responses, and 51.7% were not exposed to any educational or clinical content relevant to caring for people with intellectual disability and/or autism. Moderate to low levels of self-perceived confidence, comfort, knowledge and preparedness to address healthcare needs of these cohorts were reported. Significant associations were identified between educational and clinical experiences during undergraduate training, and higher levels of self-perceived confidence, comfort and knowledge.

Conclusion

Mirroring international literature, the findings of this study highlight a large proportion of Indonesian nurses had little educational experience relevant to caring for people with intellectual disability and/or autism, and have relatively low levels of self-reported capability.

Impact

This study highlights gaps in the educational experiences, and self-perceived confidence, comfort, knowledge and preparedness of Indonesian nurses regarding caring for people with intellectual disability and/or autism. Given that internationally, people with intellectual disability and/or autism have disproportionately negative health outcomes and experiences, these findings have substantial implications for nursing curriculum, policy and professional development.

Clinical evaluation of intralesional umbilical cord‐derived mesenchymal stem cells, conditioned medium and triamcinolone acetonide injection for keloid treatment: A pilot study

Abstract

Topical keloid therapy is performed with triamcinolone acetonide (TA) intralesional injection. However, the recurrence rate is high with various side effects. Mesenchymal stem cells (MSCs) have high proliferative abilities and reduce the activity and proliferation of fibroblast cells in keloids. To overcome the costs and limitations, conditioned medium (CM) is used. This study aims to evaluate feasibility of intralesional injection of umbilical cord MSC (UC-MSC) and conditioned medium (UC-CM) compared to TA for keloid therapy. Twenty-four patients with keloids who met the inclusion criteria were included, randomized into three treatment groups and then got assessed for the sociodemographic data, keloid volume, histopathology (type 1:3 collagen ratio), interleukin-10 (IL-10) levels and Patient and Observer Scar Assessment Scale (POSAS) score during visits. Largest volume regression occurred in the UC-MSC group, followed by UC-CM and then the TA group (UC-MSC: 45.32% ± 2.61%; UC-CM: 43.61% ± 3.67%; TA: 28.34% ± 3.81%; p = 0.003). Similar pattern was also observed in increase in IL-10 levels, the decrease in POSAS scores and the reduction of type 1:3 collagen ratio. Hence, UC-MSC and UC-CM are promisingly more effective than TA for keloid therapy, showcasing their superiority in reducing keloid volume, symptoms and type 1:3 collagen ratio, as well as increasing the levels of IL-10.

Consulta puerperal: ¿las enfermeras egresadas de una residencia obstétrica realizan esta práctica?

Objetivo principal: comprender cómo se ha realizado la asistencia ofrecida en consultas puerperales por enfermeros egresados de un programa de residencia en enfermería obstétrica en una Universidad Pública del Sur de Minas Gerais. Metodología: estudio cualitativo, descriptivo y exploratorio, se utilizó el análisis de contenido de Bardin. La población está compuesta por ocho enfermeras parteras y la recolección de datos consistió en entrevistas semiestructuradas, en línea, a través de la plataforma Skype. Principales resultados: surgieron cuatro categorías temáticas, entre ellas: “Atención integral en la consulta puerperal”; “Facilidades, dificultades y posibilidades para realizar la consulta puerperal”; “Uso de metodologías activas en las consultas prenatales y puerperales para la educación en salud”, y “Las bases de la humanización del cuidado de enfermería a la puérpera”. Principal conclusión: se verificó que actúan de forma calificada, humanizada, integral, en concordancia con la literatura científica e identificadas dificultades, facilidades y posibilidades, así como la realización de la educación en salud y humanización de la atención puerperal.

Prevalencia del catéter venoso periférico en un hospital terciario: elección en función del tratamiento

Objetivo: Determinar la prevalencia del catéter venoso periférico y conocer si su elección es adecuada en función del tratamiento. Metodología: Estudio observacional transversal realizado en la Unidad de Medicina Interna de un hospital de tercer nivel. Análisis descriptivo e inferencial mediante explotación de datos de forma pseudoanonimizada y retrospectiva. Resultados: El 96,6% de pacientes fueron portadores de catéteres venosos periféricos con una media de días de catéter de 3, 62. Los motivos de retirada más frecuentes fueron la extravasación (51,4%), el fin de tratamiento (16,2%) y la flebitis (12,8%). El tratamiento endovenoso fue superior a 6 días en un 40,4% de los pacientes y considerado vesicante y/o irritante en un 56,4%. Conclusiones: Existe un sobre uso del catéter venoso periférico, resultando primordial el diseño e implementación de estrategias con enfoque multidisciplinar que favorezcan una adecuada elección y manejo de los accesos vasculares.

Sociodemografía de los hábitos alimentarios. Una investigación en jóvenes universitarios de Alicante

Objetivo principal: el objetivo de esta investigación es describir los hábitos de consumo alimentario y determinar qué variables sociodemográficas, dentro del colectivo de los estudiantes jóvenes universitarios, están implicadas en la elección de los alimentos. Metodología: se aplicó un cuestionario ad hoc, anónimo y auto-administrado a 599 estudiantes de la Universidad de Alicante, matriculados en el curso académico 2018/2019. Resultados principales: los resultados muestran que los jóvenes universitarios concentran sus ingestas en la comida (90,2%) y la cena (82%). Se evidenció, además, que los alimentos incluidos en la dieta mediterránea se consumen dos o tres veces por semana en esta población, pero en porcentajes diferentes. Los datos confirman que los educados en un estilo democrático consumen, en un 59%, alimentos enriquecidos con vitaminas y minerales por encima de otros estilos educativos familiares. De los estudiantes que afirmaban consumir alimentos precocinados un 51,9% pertenecen a un estilo educativo democrático, un 32,3% al permisivo, un 14,6% al autoritario y un 1,2% al negligente, lo que confirma la influencia de la cultura educativa familiar en los hábitos de alimentación de este grupo etario para esta variable. Conclusión principal: se concluye que las pautas definitorias de la dieta mediterránea han perdido protagonismo en este grupo poblacional, al comparar sus resultados con los de otros momentos históricos. Además, los resultados obtenidos muestran que los estilos de crianza no influyen de forma determinante en la elección de la alimentación en la etapa universitaria, a excepción del consumo alimentos precocinados.

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