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Ayer — Mayo 14th 2024Tus fuentes RSS

Study protocol for assessment of the efficacy of calcium dobesilate versus placebo on SARS-CoV-2 viral load in outpatients with COVID-19 (CADOVID study): a randomised, placebo-controlled, double-blind, monocentric phase II trial

Por: Salamun · J. · Da Silva · T. · Ustero · P. · Gosmain · Y. · Guessous · I. · Calmy · A. · Spechbach · H.
Introduction

SARS-CoV-2 mainly infects respiratory endothelial cells, which is facilitated through its spike protein binding to heparan sulphate. Calcium dobesilate (CaD) is a well-established, widely available vasoactive and angioprotective drug interacting with heparan sulphate, with the potential to interfere with the uptake of SARS-CoV-2 by epithelial cells. The CADOVID trial aims to evaluate the efficacy and safety of CaD in reducing the SARS-CoV-2 viral load in non-hospitalised adult patients diagnosed with COVID-19, confirmed by a positive SARS-CoV-2 PCR, including its efficacy to reduce the impact of persistent COVID-19 symptoms.

Methods and analysis

This is a randomised, placebo-controlled, double-blind, monocentric phase II trial. Enrolment began in July 2022. A total of 74 adult patients will be randomly allocated to the CaD arm or the placebo group with a 1:1 ratio, respectively. Participants in the intervention arm will receive two capsules of CaD 500 mg two times per day and the placebo arm will receive two matching capsules of mannitol 312.5 mg two times per day, with a treatment period of 7 days for both arms, followed by a 77-day observational period without treatment administration. Participants will be asked to complete secured online questionnaires using their personal smartphone or other electronic device. These include a COVID-19 questionnaire (assessing symptoms, temperature measurement, reporting of concomitant medication and adverse events), a COVID-19 persistent symptoms’ questionnaire and the Short Form 12-Item (SF-12) survey. SARS-CoV-2 PCR testing will be performed on nasopharyngeal swabs collected on days 1, 4, 8 and 21. The primary endpoint is the reduction from baseline of SARS-CoV-2 viral load determined by RT-PCR at day 4.

Ethics and dissemination

This trial has received approval by the Geneva Regional Research Ethics Committee (2022-00613) and Swissmedic (701339). Dissemination of results will be through presentations at scientific conferences and publication in scientific journals.

Trial registration number

NCT05305508; Clinicaltrials.gov; Swiss National Clinical Portal Registry (SNCTP 000004938).

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Parents' Trigger Tool for Children with Medical Complexity – PAT‐CMC: Development of a recognition tool for clinical deterioration at home

Abstract

Aim

To develop a trigger tool for parents and lay caregivers of children with medical complexity (CMC) at home and to validate its content.

Design

This was a multi-method study, using qualitative data, a Delphi method and a concept mapping approach.

Methods

A three-round electronic Delphi was performed from December 2021 to April 2022 with a panel of 23 expert parents and 30 healthcare providers, supplemented by a preliminary qualitative exploration of children's signs of deterioration and three consensus meetings to develop the PArents' Trigger Tool for Children with Medical Complexity (PAT-CMC). Cognitive interviews with parents were performed to assess the comprehensiveness and comprehensibility of the tool. The COREQ checklist, the COSMIN guidelines and the CREDES guidelines guided the reporting respectively of the qualitative study, the development and content validity of the trigger tool and the Delphi study.

Results

The PAT-CMC was developed and its content validated to recognize clinical deterioration at home. The tool consists of 7 main clusters of items: Breathing, Heart, Devices, Behaviour, Neuro-Muscular, Nutrition/Hydration and Other Concerns. A total of 23 triggers of deterioration were included and related to two recommendations for escalation of care, using a traffic light coding system.

Conclusion

Priority indicators of clinical deterioration of CMC were identified and integrated into a validated trigger tool designed for parents or other lay caregivers at home, to recognize signs of acute severe illness and initiate healthcare interventions.

Impact

The PAT-CMC was developed to guide families in recognizing signs of deterioration in CMC and has potential for initiating an early escalation of care. This tool may also be useful to support education provided by healthcare providers to families before hospital discharge.

Patient or Public Contribution

Parents of CMC were directly involved in the selection of relevant indicators of children's clinical deterioration and the development of the trigger tool. They were not involved in the design, conducting, reporting or dissemination plans of this research.

Pérdida significativa como factor del alcoholismo

La relación de la pérdida significativa de un ser querido y el alcoholismo ha minimizado las implicaciones sobre mecanismos de afrontamientos para generar conductas saludables. Este artículo se basa en entrevistas semiestructuradas a profundidad en hombres de entre 30 y 70 años, con más de 10 años en Alcohólicos Anónimos del Estado de Tamaulipas, México. El objetivo fue reflexionar sobre los significados de la pérdida significativa de un ser querido y el alcoholismo. En la búsqueda del significado, se explica que un factor que lleva al alcoholismo no es una sola pérdida significativa de personas queridas, sino un cúmulo también de pérdidas materiales y no materiales, se reflejaron recursos limitados para afrontar las pérdidas, la relación entre la pérdida significativa con el alcoholismo fue mediado por dos principales aspectos, las creencias sobre los efectos que produce el consumo de alcohol como formas de escapar de la realidad y las influencia de la familia al inicio del consumo de alcohol. Por otra parte, la presencia de lo espiritual, la conciencia y las emociones que experimentan durante su proceso de duelo y alcoholismo, los llevó a identificar el problema de la adicción, que permitió influir en el proceso de rehabilitación.

Deciphering the role of wound healing genes in skin cutaneous melanoma: Insights into expression, methylation, mutations, and therapeutic implications

Abstract

Skin Cutaneous Melanoma (SKCM) is a form of cancer that originates in the pigment-producing cells, known as melanocytes, of the skin. Delay wound healing is often correlated with the occurrence of and progression of SKCM. In this comprehensive study, we investigated the intricate roles of two important wound healing genes in SKCM, including Matrix Metalloproteinase-2 (MMP2) and Matrix Metalloproteinase-9 (MMP9). Through a multi-faceted approach, we collected clinical samples, conducted molecular experiments, including RT-qPCR, bisulphite sequencing, cell culture, cell Counting Kit-8, colony formation, and wound healing assays. Beside this, we also used various other databases/tools/approaches for additional analysis including, UALCAN, GEPIA, HPA, MEXPRESS, cBioPortal, KM plotter, DrugBank, and molecular docking. Our results revealed a significant up-regulation of MMP2 and MMP9 in SKCM tissues compared to normal counterparts. Moreover, promoter methylation analysis suggested an epigenetic regulatory mechanism. Validations using TCGA datasets and immunohistochemistry emphasized the clinical relevance of MMP2 and MMP9 dysregulation. Functional assays demonstrated their synergistic impact on proliferation and migration in SKCM cells. Furthermore, we identified potential therapeutic candidates, Estradiol and Calcitriol, through drug prediction and molecular docking analyses. These compounds exhibited binding affinities, suggesting their potential as MMP2/MMP9 inhibitors. Overall, our study elucidates the diagnostic, prognostic, and therapeutic implications of MMP2 and MMP9 in SKCM, shedding light on their complex interplay in SKCM occurrence and progression.

NURE Investigación ante los nuevos criterios de valoración de la ANECA

Los nuevos criterios establecidos para el acceso a los cuerpos docentes en España por la Agencia Nacional de la Evaluación de la Calidad y Acreditación (ANECA) van a servir para evaluar de forma más justa los méritos de investigación. Los nuevos criterios restan importancia al factor de impacto de las revistas, valorando la calidad de estas en base a criterios más objetivos, como el hecho de que se encuentren indexadas en bases de datos de referencia. Creo que este puede ser otro importante paso hacia el fin de esa suerte de mercadeo en la que se había convertido la publicación científica en los últimos años y deseo que esta forma de evaluar los méritos de investigación traslade, también, a otros países.

ABSTRACT

The brand new criteria established for accessing to university teaching jobs in Spain by the National Agency for Quality Assessment and Accreditation (ANECA) will serve to evaluate research merits in a more fair way. The new criteria downplay the importance of the journals' impact factor, assessing the quality of the journals according to more objective criteria, such as the fact that they are indexed in reference databases. I believe that this could be another important step towards the end of the kind of marketing that scientific publishing had become in recent years, and I hope that this way of evaluating the merits of research will also be transferred to other countries.

Beyond the burn: An observational study of cardiovascular risk in burn survivors in the north of Iran

Abstract

Burn survivors experience profound physiological changes following injury, which may have lasting implications for cardiovascular health. This study aims to investigate the cardiovascular risk profile among burn survivors treated at a burn center in northern Iran. This observational study was conducted from 2022 to 2023 at the burn centre affiliated with Guilan University of Medical Sciences, Rasht, Iran. This study assessed a cohort study of 210 burn survivors, focusing on individuals with ≥20% TBSA burn injuries who had recovered and returned to their daily lives. This study assessed patients' lipid profiles, Framingham General Cardiovascular Risk Score (FGCRS) and risk factors, including demographics, clinical variables and physical activity. Statistical analysis employed descriptive and inferential statistics. The mean age was 49.23 years, and the mean TBSA burned was 37.06%. The risk of cardiovascular disease in 66% of the study population was less than 10%, and in 13%, it was more than 20%. Significant associations were identified between CVD risk and sex, diabetes, hypertension, BMI, TBSA burned, years after burn, physical activity level and LDL. Of the lipid profile measures, LDL, triglycerides and TC/HDL exceeded the desirable levels. This research highlights the heightened cardiovascular risk in burn survivors, emphasizing the necessity for targeted interventions and regular monitoring. Identifying modifiable risk factors enables healthcare practitioners to develop tailored strategies, enhancing cardiovascular health in this vulnerable population and improving overall outcomes and quality of life.

Does a program‐based cognitive behavioral therapy affect insomnia and depression in menopausal women? A randomized controlled trial

Abstract

Background

Menopausal women often complain of a range of physical and psychological symptoms known as menopausal syndrome. These symptoms are associated with fluctuating hormone levels, sleep disturbances, and mood swings.

Aim

This study aimed to examine the efficacy of a program-based cognitive behavioral group therapy (CBT) for insomnia and depression among women experiencing menopause.

Methods

A randomized controlled trial of 88 women experiencing menopause was conducted in Egypt from June to September 2022 in outpatient clinics at Mansoura University Hospitals in Egypt. Participants were randomly assigned to a control group (45 women) and an intervention group (43 women). The intervention group received 7 weeks of CBT sessions. Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), and Beck Depression Inventory 2nd Edition (BDI-II) were administered before and after the intervention.

Results

In the intervention group, there was a significant difference in scores of the subdomains of PSQI, including sleep efficiency, daytime dysfunction, subjective sleep quality, and sleep disturbance (t = 8.911, 11.77, 7.638, and 11.054, respectively), while no significant difference in domains of using sleep medication, sleep duration, and sleep latency. Significant improvements were observed between pre-and-post-intervention in the intervention group for the total scores of PSQI, ISI, and BDII-II (t = 12.711, 16.272, and 12.384, respectively), indicating a large effect size for the three studied variables (r = .81, .87, .8, respectively).

Linking Evidence to Action

This study demonstrated the efficacy of group CBT for lowering insomnia and depression in women experiencing menopause. Thus, results indicated the need of considering prompt and appropriate interventions such as CBT as a safe treatment option to prevent the aggravation of sleep and emotional problems for menopausal women.

Trial Registration

ClinicalTrials.gov Identifier: NCT05920460.

Development and psychometric evaluation of an expanded urinary catheter self‐management scale: A cross‐sectional study

Abstract

Aim

To develop and test the psychometric properties of an expanded catheter self-management scale for patients with in-dwelling urinary catheters.

Design

A cross-sectional validation study. Despite the utility of the original 13-item catheter self-management scale, this instrument did not include bowel management, general hygiene and drainage bag care, which are fundamental skills in urinary catheter self-management to prevent common problems resulting in unnecessary hospital presentations. The expanded catheter self-management scale was developed with 10 additional items to comprehensively assess all five essential aspects of urinary catheter self-management.

Methods

A total of 101 adult community-dwelling patients living with indwelling urinary catheters were recruited from Western Sydney, Australia. Using exploratory factor analysis with Varimax rotation, the number of factors to be extracted from the expanded 23-item expanded catheter self-management scale was determined using a scree plot. The reliability of the overall scale and subscales was measured using Cronbach's alpha. Convergent validity was assessed using Spearman's correlations between clinical characteristics, overall scale and subscales.

Results

The 23-item expanded catheter self-management scale yielded a 5-factor solution, labelled as: (i) self-monitoring of catheter function, (ii) proactive, help-seeking behaviour function, (iii) bowel self-care function, (iv) hygiene-related catheter site function and (v) drainage bag care function. Cronbach's alpha of the expanded catheter self-management scale indicating all 23 items contributed to the overall alpha value. Convergent validity results showed a negative correlation between the overall expanded catheter self-management scale and catheter-related problems.

Conclusion

The 5-factor structure provided a comprehensive assessment of key aspects of urinary catheter self-management essential to reduce the likelihood of catheter-related hospital presentations.

Implications

The expanded catheter self-management scale can be used to assess and monitor effective patient-centred interventions for optimal self-management to prevent catheter-related problems and improve the quality of life of patients.

Impact

Many patients start their journey of living with a urinary catheter unexpectedly and are not supported with quality information to care for their catheter. The findings of this study show the correlation between catheter self-management skills and catheter-related problems. The expanded catheter self-management scale (E-CSM) assists with analysing the self-management skills of patients living with a catheter and developing tailored interventions to prevent problems and improve their quality of life. In addition, this screening tool can be included in policies, guidelines, and care plans as a standard for improving catheter management and developing educational resources for patients.

Reporting Method

STROBE checklist was used to report all aspects of this study comprehensively and accurately.

Patient or Public Contribution

Patients living with indwelling urinary catheter and their carers have participated in surveys, interviews and co-designing interventions. This paper reports the psychometric analysis of the expanded catheter self-management scale (E-CSM) used in the patient survey as part of the main study ‘Improving Quality of Life of Patients Living with Indwelling Urinary Catheters: IQ-IDC Study’ (Alex et al. in Collegian, 29:405–413, 2021). We greatly value our consumers' contributions and continue to communicate the progress of the study to them. Their contributions will be acknowledged in all publications and presentations. In addition, all participants will be provided the option of receiving the interventions and publications generated from this study.

Preguntas clínicas como generadoras de conocimiento para la toma de decisiones en enfermería

la toma de decisiones en el ámbito clínico sigue haciéndose, con mucha frecuencia, sin considerar los hallazgos de los estudios. Habitualmente, decidimos cuál es la mejor manera de actuar en situaciones concretas basándonos nuestra experiencia personal (que puede provenir de la observación o del ensayo-error) o llegando a un consenso entre las enfermeras que atienden al paciente. Parece que, aunque la investigación y la necesidad de basarnos en la mejor evidencia disponible es algo incuestionable cuando hablamos de cuidados, cuando atendemos a pacientes en el entorno clínico, obviamos esa fuente de conocimiento que es la investigación. ¿Pero realmente lo obviamos o realmente no tenemos evidencia en la que basarnos?

Midwives' stress and burnout during the Omicron wave in Italy: An observational survey

Abstract

Aim

To evaluate midwives' level of stress and burnout during the COVID-19 Omicron phase in Italy. Secondary aims were to explore the impact of the pandemic on midwives' personal dimensions and professional activities and potential supporting strategies.

Design

A mixed-methods study was undertaken from July to December 2022.

Methods

Data were collected using a national online observational survey. Descriptive and inferential analyses were performed to evaluate stress, burnout and the impact of the pandemic on personal and professional dimensions. A deductive qualitative approach was used to analyse open-ended responses, that were merged with quantitative data following a convergent mixed-methods approach.

Results

A total of 1944 midwives participated in the survey. The stress summary score mean was 10.34, and 562 midwives (28.91%) experienced burnout. The intention to reduce working hours was reported by 202 midwives (10.39%), with 60.40% (n = 122) of them experiencing burnout. The intention to leave clinical practice within the following 2 years was reported by 239 (12.29%), with 68.20% (n = 163) of them experiencing burnout. All the personal dimensions and professional activities considered were defined by more than half of midwives as being impacted ‘Moderately’ or ‘To a great extent’ by pandemic. Stress and burnout frequencies increased when the midwives' perception of the pandemic effects was higher. Potential supporting strategies described by midwives as the most important in increasing their ability to cope with the pandemic were ‘Women's awareness of the midwives' role’ (n = 1072; 55.14%) and ‘Family and friends' emotional support’ (n = 746; 38.38%).

Conclusion

Our findings suggested strategies to support a positive and safe working environment for midwives during a pandemic emergency, with potential transferability to similar contexts when human resources are lacking. It is recommended that maternity services provide the necessary resources for a safe and supportive working environment to prevent high stress levels and chronic burnout.

Impact

Studies conducted during the first COVID-19 pandemic wave showed an increased level of stress, anxiety, burnout, post-traumatic stress disorder and depression experienced by healthcare professionals; moreover, midwives experienced drastic changes in care pathways and policies with struggles identified when providing high-quality woman-centred care following pandemic restrictions. Although it is recommended, there is lack of knowledge about long-term psychological effects of COVID-19 for midwives. Our study highlights that during the Omicron wave midwives experienced a high level of stress and burnout with an impact on individual dimensions and professional activities. Their stress and burnout were influenced by several factors, including restrictions in place, lack of organizational acknowledgement, work overload and need for extra childcare cover. Maternity services should provide the necessary resources for a safe and supportive working environment to prevent high stress levels and chronic burnout. Recommendations on how to facilitate this are suggested.

Reporting Method

During the writing process, we referred to ‘The Strengthening the Reporting of Observational Studies Epidemiology Statement’, the guidelines for reporting observational studies from the Equator network.

Patient or Public Contribution

No patient or public contribution.

What does this paper contribute to the wider global clinical community?

Work overload conditions negatively impacted on the quality of maternity services. Improving organizational aspects, reducing working hours, promoting family and friends' emotional support and improving women's awareness of midwife's role were the main strategies reported by midwives. These suggestions for ensuring a positive and safe working environment for midwives during a pandemic emergency could potentially be applied to similar situations where human resources are lacking.

Exploring the Documentation of Delirium in Patients After Cardiac Surgery: A Retrospective Patient Record Study

imageDelirium is a common disorder for patients after cardiac surgery. Its manifestation and care can be examined through EHRs. The aim of this retrospective, comparative, and descriptive patient record study was to describe the documentation of delirium symptoms in the EHRs of patients who have undergone cardiac surgery and to explore how the documentation evolved between two periods (2005-2009 and 2015-2020). Randomly selected care episodes were annotated with a template, including delirium symptoms, treatment methods, and adverse events. The patients were then manually classified into two groups: nondelirious (n = 257) and possibly delirious (n = 172). The data were analyzed quantitatively and descriptively. According to the data, the documentation of symptoms such as disorientation, memory problems, motoric behavior, and disorganized thinking improved between periods. Yet, the key symptoms of delirium, inattention, and awareness were seldom documented. The professionals did not systematically document the possibility of delirium. Particularly, the way nurses recorded structural information did not facilitate an overall understanding of a patient's condition with respect to delirium. Information about delirium or proposed care was seldom documented in the discharge summaries. Advanced machine learning techniques can augment instruments that facilitate early detection, care planning, and transferring information to follow-up care.

Endoscopic retrograde cholangiopancreatography utilisation and outcomes in the first advanced endoscopy centre in Palestine at Al-Ahli Hospital: a retrospective cohort study

Por: Salama · H. Z. · Alnajjar · Y. A. · Owais · T. A. · Jobran · A. W. M. · Safi · R. · Bahar · M. · Al-Ashhab · H.
Objective

To evaluate the utilisation and outcomes of endoscopic retrograde cholangiopancreatography (ERCP) procedures, success rates, incidence and risk factors for procedural-related complications in a single centre-based study.

Study design

Retrospective cohort study.

Setting

First advanced tertiary endoscopy centre in Palestine.

Participants

A total of 1909 procedures on 1303 patients were included in the analysis: females were 57.9% of the cases (n=755), 1225 patients (94%) were from West Bank and Jerusalem and 78 (6%) were from Gaza Strip. All patients who underwent ERCP throughout the period from December 2017 to September 2022 were selected to participate in the study.

Primary and secondary outcome measures

The primary outcomes of interest in our analysis were success rates, procedural outcomes and post- procedural complications including pancreatitis, bleeding and others. Two multivariate logistic regression models were performed to calculate the risk of post-ERCP complications and post-ERCP pancreatitis (PEP) in patients with certain risk factors like demographic factors, procedural techniques' variation, pancreatic duct manipulations and others. We also discussed the management of the failed procedures.

Results

The overall complication rate was 5%, including PEP (n=43, 2.3%), infection/cholangitis (n=20, 1%), bleeding (n=9, 0.5%) and perforation (n=7, 0.4%). The mortality rate was 0.6% (n=11). Risk factors for adverse events included pancreatic duct cannulation and PEP (p

Conclusions

We summarised the utilisation and outcomes of ERCP among the Palestinian population in the first advanced centre in Palestine. Cannulation success rates are similar to the established standards and are acceptable compared with other centres worldwide. Perioperative complication rates of ERCP remain infrequent, and death is quite unusual and thus considered a safe procedure.

Impact of virtual reality‐based therapy on post‐stroke depression: A systematic review and meta‐analysis of randomized controlled trials

Abstract

Background

Post-stroke depression is the most common neuropsychiatric consequence and reduces rehabilitation effectiveness. However, the efficacy of virtual reality (VR) on mental health treatment for patients after a stroke is uncertain.

Aims

The aim of this study was to evaluate the efficacy of VR as a co-adjuvant form of treatment to reduce depression in stroke patients admitted to neurorehabilitation units.

Methods

We systematically searched medical databases including PubMed, CINAHL, PsycINFO, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov from inception to November 16, 2023. Clinical trials comparing the use of VR as an adjuvant form of treatment in stroke patients' rehabilitation with the usual treatment were included. Pooled standardized mean differences were calculated using a random-effects model. Subgroup analyses were performed according to type of stroke, VR characteristics, and the scale used to measure depression. Meta-regression analysis was performed for intervention duration and to determine the mean age of the participants.

Results

Eight studies and 388 stroke patients were included. The VR interventions were associated with a lower risk of depression in patients (ES = −0.69; 95% CI [−1.05, −0.33]; I 2 = 57.6%; p ≤ .02). The estimates were not affected by the type of stroke, the type of VR used, the blinding process, the type of scale used to detect depression, the duration of the intervention (weeks and minutes), and the total number of sessions. Meta-regression shows that younger samples (p = .00; 95% CI [0.01, 0.08) and longer interventions (p = < .05; 95% CI [−0.00, −0.00) lead to a greater reduction in depression.

Linking Evidence to Action

This review provides an important basis for treating depression in patients after a stroke. Professionals working in stroke neurorehabilitation units should consider VR as a form of co-adjuvant treatment for depression in patients.

Systematic Review Registration

CRD42022303968.

Social media as a tool for oral health promotion: A systematic review

by Farzaneh Farrokhi, Zahra Ghorbani, Farid Farrokhi, Mahshid Namdari, Siavash Salavatian

Social media platforms are common means of sharing information, personal experiences, and lifestyle. They can also be utilized as cost-effective methods for individuals to acquire health information and promote oral health. The purpose of the present study was to systematically review the current literature on the interventions taken through social media for promoting lay people’s oral health. This systematic review (PROSPERO: CRD42023395005) followed the preferred reporting items for systematic reviews and meta-analyses (PRISMA) 2020 guidelines. A comprehensive search was conducted in four electronic databases (PubMed, Scopus, Embase, and Cochrane Library) for relevant articles published between 2012 and 2023. Data such as study design, sample size, follow-up duration, utilized social media platforms and main findings were extracted from the eligible studies. The quality of the studies included in the systematic review was evaluated by the quality assessment tools for intervention studies recommended by the National Collaborating Centre for Methods and Tools. Out of the 1934 records identified in the initial search, 10 studies met the inclusion criteria and were included in the qualitative synthesis. These studies comprised seven randomized control trials, one field trial and two quasi-experimental. Various social media platforms, including Telegram, Instagram, YouTube, WhatsApp and Snapchat, were used for communication with patients. Some studies solely utilized social media interventions, while others combined online and traditional interventions. The quality assessment categorized 30% of the studies as “strong”, 50% as “moderate”, and the remaining as “weak”. The implementation of social media interventions positively influenced multiple aspects of oral health among the laypeople. Online platforms such as YouTube, WhatsApp, Instagram, and Telegram can be effectively utilized to promote oral health among patients.

Suicidality Treatment Occurring in Paediatrics (STOP) Medication Suicidality Side Effects Scale in young people in two cohorts across Europe

Por: Santosh · P. · Sala · R. · Lievesley · K. · Singh · J. · Arango · C. · Buitelaar · J. K. · Castro-Fornieles · J. · Coghill · D. · Dittmann · R. W. · Flamarique · I. · Hoekstra · P. J. · Llorente · C. · Purper-Ouakil · D. · Schulze · U. · Zuddas · A. · Parnell · N. · Mohan · M. · Fiori · F
Objectives

As part of the ‘Suicidality: Treatment Occurring in Paediatrics (STOP)’ study, we developed and performed psychometric validation of an electronic-clinical-outcome-assessment (eCOA), which included a patient-reported-outcome (ePRO), an observer-rated-outcome (eObsRO) for parents/carers and a clinician-reported-outcome (eClinRO) that allows identification and monitoring of medication-related suicidality (MRS) in adolescents.

Design

STOP: Prospective study: A two phase validation study to assess the impact of medication on suicidal ideations.

Setting

Six participating countries: Netherlands, UK, Germany, France, Spain and Italy that were part of the Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 261411.

Participants

Cohort 1 consisted of 41 adolescent-completions, 50 parent-completions and 56 clinician-completions. Cohort 2 consisted of 244 adolescent-completions, 198 parent-completions and 240 clinician-completions from across the six countries. The scale was administered only to participants who have screened positive for the STOP-Suicidality Assessment Scale (STOP-SAS).

Results

A total of 24 items for the development of the STOP-Medication Suicidality Side Effects Scale (STOP-MS3) were identified and three versions (for patients, parents and clinicians) of the STOP-MS3 were developed and validated in two separate study cohorts comprising of adolescents, their parents and clinicians. Cronbach’s α coefficients were above 0.85 for all domains. The inter-rater reliability of the STOP-MS3 was good and significant for the adolescent (ePRO), clinician (eClinRO) (r=0.613), parent (eObsRO) versions of the scale (r=0.394) and parent and clinician (r=0.347). Exploratory factor analysis identified a 3-factor model across 24 items for the adolescent and parent version of the scale: (1) Emotional Dysregulation, (2) Somatic Dysregulation and (3) Behavioural Dysregulation. For the clinician version, a 4-factor model defined the scale structure: (1) Somatic Dysregulation, (2) Emotional Dysregulation, (3) Behavioural Dysregulation and (4) Mood Dysregulation.

Conclusion

These findings suggest that the STOP-MS3 scale, a web-based eCOA, allows identification and monitoring of MRS in the adolescent population and shows good reliability and validity.

Definition and clinical management of haemodialysis central venous catheter local infections (exit site and tunnel infection): An international consensus assessment

Abstract

Aim

To evaluate the relevance of signs and symptoms for the clinical identification of ESI and TI in HD-CVC, by means of international expert consensus, and to reach a consensus on a definition and clinical management (CM) for these infections.

Background

A recent systematic review showed a high heterogeneity in the signs/symptoms used for determining exit site infection (ESI) and tunnel infection (TI) of haemodialysis central venous catheter (HD-CVC).

Design

A modified Delphi ranking process was carried out between November 2020 and March 2021, consisting of four rounds using an online questionnaire with a panel of 26 experts from 12 countries.

Methods

Experts responded on the level of relevance for the identification of ESI and TI, based on a list of 22 signs/symptoms obtained from a previous systematic review, using a 4-point Likert-type scale. After reaching consensus on the signs/symptoms, they followed the same method to reach consensus on the CM. The STROBE Checklist was used to report this study.

Results

A high degree of consensus was reached to identify the presence of ESI based on nine signs/symptoms: presence of pain at the exit site (ES) during interdialysis period, with fever ≥38°C do not suspect other cause, local signs at the ES (inflammation, induration, swelling, hyperemia/erythema ≥2 cm from ES) and obvious abscess or purulent exudate at ES; and of TI. Likewise, 5 cm were agreed upon.

Conclusion

This Delphi study provides international expert consensus definitions of ESI and TI in HD-CVC, laying the groundwork for the validation of an HD-CVC ES clinical assessment scale for early identification of ESI.

Relevance to Clinical Practice

In addition, this study provides a series of attitudes to consensual clinics regarding signs/symptoms of local infections in HD-CVC, which may be useful as expert opinion in clinical practice guidelines, when there is insufficient scientific evidence.

Investigating the relationship of COVID-19 preventive and mitigation measures with mosque attendance in Pakistan

by Hamza Umer, Muhammad Salar Khan

Social distancing served as a principal strategy to curtail the spread of COVID-19. However, congregational activities in mosques made it challenging to practice social distancing and led to a rapid surge in virus infections in several Muslim countries. This study uses nationally representative cross-sectional data from Pakistan, a Muslim-majority country, to examine the relationship of practicing preventive measures (such as social distancing, wearing mask and hand washing) and mitigation measures (like avoid going to the market, social gatherings, healthcare seeking, use of public transport, and long-distance travel) with mosque visits by utilizing logistic regressions. The results show that individuals adhering to preventive and mitigation measures also avoid visiting mosques and other religious gatherings. From a policy perspective, these results suggest that the government of Pakistan can avoid direct religious confrontation when it needs to minimize mosque visits to curtail the spread of the virus by implementing preventive and mitigation measures.

20 años divulgando investigación enfermera de calidad

Nure Investigación lleva más de 20 años divulgando investigación enfermera de calidad. La revista se creó con la finalidad de publicar artículos y trabajos de investigación de forma libre y gratuita, alineados con el compromiso de la Fundación para el Desarrollo de la Enfermería (Fuden) por mejorar la salud de la población, ya que sabemos que los cuidados de mayor calidad son aquellos que se basan en la evidencia científica. Fieles a nuestra vocación de servicio, hemos intentado que Nure diera respuesta a las necesidades de las enfermeras en cada momento, y secciones como el de “Formación Metodológica” o el de “Originales para la práctica clínica”, que tan buena acogida han tenido entre los lectores, dan buena cuenta de ello.

Hoy día, nos congratula celebrar este 20 aniversario gracias a los autores, que saben que la publicación de sus artículos en Nure Investigación supone publicar en una revista internacional, referente en la disciplina, indexada en las principales bases de datos de enfermería y comprometida con las buenas prácticas de la publicación científica. Quienes hacemos posible Nure (revisores externos, maquetadores, diseñadores gráficos, comité editorial) seguiremos trabajando para crecer y mejorar cada día.

ABSTRACT

Nure Investigación has been publishing quality research nursing for 20 years. The journal was created to publish articles and research topics in an open access format, aligned to the commitment of the Nursing Development Foundation (Fuden) regarding the improvement of health population, as we know high quality care need to be based on scientific evidence. True to our service vocation, we have tried Nure to response the nursing needs every momento and sections such as “Methodological Training” or “Originals for clinical practice”, which has had a good reception among readers, show it.

Nowadays, we are proud to celebrate this 20 anniversary thank you to the authors, who know that publishing their article in Nure Investigación means publishing in an international journal, referrer among the discipline, indexed in the most important nursing database and enganged with the best practices in scientific publishing. Those who make Nure possible (reviewers, layout and graphic designer, editorial committee) will keep on working for growing and improving day by day.

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