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Validation of the prevalence to incidence conversion method for healthcare associated infections in long-term care facilities

by Costanza Vicentini, Enrico Ricchizzi, Antonino Russotto, Stefano Bazzolo, Catia Bedosti, Valentina Blengini, Dario Ceccarelli, Elisa Fabbri, Dario Gamba, Anna Maddaleno, Edoardo Rolfini, Margherita Tancredi, Carla Maria Zotti

Introduction

Residents of long-term care facilities (LTCFs) are a population at high risk of developing severe healthcare associated infections (HAIs). In the assessment of HAIs in acute-care hospitals, selection bias can occur due to cases being over-represented: patients developing HAIs usually have longer lengths of stays compared to controls, and therefore have an increased probability of being sampled in PPS, leading to an overestimation of HAI prevalence. Our hypothesis was that in LTCFs, the opposite may occur: residents developing HAIs either may have a greater chance of being transferred to acute-care facilities or of dying, and therefore could be under-represented in PPS, leading to an underestimation of HAI prevalence. Our aim was to test this hypothesis by comparing HAI rates obtained through longitudinal and cross-sectional studies.

Methods

Results from two studies conducted simultaneously in four LTCFs in Italy were compared: a longitudinal study promoted by the European Centre for Disease Prevention and Control (ECDC, HALT4 longitudinal study, H4LS), and a PPS. Prevalence was estimated from the PPS and converted into incidence per year using an adapted version of the Rhame and Sudderth formula proposed by the ECDC. Differences between incidence rates calculated from the PPS results and obtained from H4LS were investigated using the Byar method for rate ratio (RR).

Results

On the day of the PPS, HAI prevalence was 1.47% (95% confidence interval, CI 0.38–3.97), whereas the H4LS incidence rate was 3.53 per 1000 patient-days (PDs, 95% CI 2.99–4.08). Conversion of prevalence rates obtained through the PPS into incidence using the ECDC formula resulted in a rate of 0.86 per 1000 PDs (95% CI 0–2.68). Comparing the two rates, a RR of 0.24 (95% CI 0.03–2.03, p 0.1649) was found.

Conclusions

This study did not find significant differences between HAI incidence estimates obtained from a longitudinal study and through conversion from PPS data. Results of this study support the validity of the ECDC method.

Being a nurse between research and clinic: What challenges and opportunities for a PhD‐prepared nurse? Overview from an Italian paediatric hospital

Abstract

Aim

To report a reflection on the role, challenges and opportunities for nurses with advanced education in research outside the academic field.

Design

A discursive paper.

Data Sources

We reported the case of an Italian paediatric research hospital where PhD-prepared nurses started to apply their knowledge and competencies in different fields, both in clinical and organizational settings. From this experience, an overview of the possible barriers and challenges that PhD-prepared nurses may face up within the hospital setting.

Discussion

The application of PhD-prepared nurses in hospital settings could be an opportunity to advance high standards of quality of care in managerial and clinical areas and to create networks between highly specialized professional figures and different clinical-care realities.

Conclusion

More research is needed to explore how to apply the advanced competencies of PhD-prepared nurses within healthcare organizations to provide high-quality and safe care and services.

This paper can provide insights for a reflection on applying and developing PhD-prepared nurses' skills and competencies within the hospital setting in clinical, research and managerial areas. This can enhance the effective application of highly competent nursing professional figures.

Patient or Public Contribution

No Patient or Public Contribution, due to study design.

Psychometric properties of the Fluoride Hesitancy Identification Tool (FHIT)

by Adam C. Carle, Isabella Pallotto, Todd C. Edwards, Richard Carpiano, Darragh C. Kerr, Donald L. Chi

Introduction

Some caregivers are hesitant about topical fluoride for their children despite evidence that fluoride prevents caries and is safe. Recent work described a five domain model of caregivers’ topical fluoride hesitancy. We developed the Fluoride Hesitancy Identification Tool (FHIT) item pool based on the model. This study sought to evaluate the FHIT’s psychometric properties in an effort to generate a short, simple to score, reliable, and valid tool that measures caregivers’ topical fluoride hesitancy.

Methods

In 2021 and 2022, we conducted an observational, cross-sectional study of caregivers, collecting data from two independent caregiver samples (n1 = 523; n2 = 612). The FHIT item pool included 33 items. We used confirmatory factor analyses (CFA) to examine whether the FHIT items measured five separate domains as hypothesized and to reduce the number of items. We then fit item response theory (IRT) models and computed Cronbach’s alpha for each domain. Last, we examined the construct validity of the FHIT and evaluated scoring approaches.

Results

After dropping 8 items, CFA supported a five factor model of topical fluoride hesitancy, with no cross-loadings (RMSEA = 0.079; SRMR = 0.057; CFI = 0.98; TLI = 0.98). We further reduced the items to four per domain (20 items total). Marginal alphas showed that the item sets provided reliability of ≥0.90 at hesitancy levels at and above average. The domains correlated more strongly with each other and topical fluoride refusal than with other questions on the survey.

Discussion

Our results support the FHIT’s ability to reliably and validly measure five domains of topical fluoride hesitancy using the average score of the four items in each domain.

Self‐identified culturally related stressors that influence self‐care in older adults with multiple chronic conditions: A qualitative study

Abstract

Aim

To identify culturally related stressors that influence self-care in Chinese older adults with multiple chronic conditions.

Background

Effective self-care can improve health outcomes for chronic conditions, but implementing self-care is challenging. Individuals with multiple chronic conditions face even more self-care complexity than those with single chronic conditions, generating additional stressors. Although stressors have been found to negatively influence self-care in multiple chronic conditions, the role of culture in generating stressors has been neglected.

Design

This paper reports on the qualitative component of a larger mixed-methods study. Two free-response items in a survey were used to identify culturally related stressors that influence self-care. This report adhered to the SRQR guideline checklist.

Methods

Data were collected between January and April 2022. One hundred and thirty-eight free text responses asking participants to identify stressors that influenced their self-care effectiveness were analysed sequentially using deductive content analysis and thematic analysis.

Results

Findings from deductive content analysis largely confirmed published work in Western literature on stressors complicating self-care, including symptom burdens, financial strains, social disconnection, caregiving responsibilities and major life events. Findings from reflexive thematic analysis extended current literature by identifying three culturally relevant stressors: intergenerational obligations and commitments, ambivalence about receiving care and worries about potential problems.

Conclusion

Chinese older adults with multiple chronic conditions identified a wide range of stressors that impacted their day-to-day self-care. This study provided valuable insights into culturally related stressors in older adults with multiple chronic conditions. Findings deepened our knowledge of cultural influences on the success of self-care in older adults with multiple chronic conditions, suggesting the potential for reaching populations across different cultures and regions.

Implications for the profession and/or patient care

Stressors that might influence self-care ability are important for nurses to assess in people with multiple chronic conditions. The design of self-care interventions should take a culturally tailored intergenerational family-centred approach to help mitigate the impact of stressors and ultimately improve patient outcomes.

Impact

What problem did the study address?

Stressors documented in older adults with MCCs have all been generated from research with Western populations. China is now home to the largest population of older people in the world. Understanding the influence of culturally relevant stressors on self-care in Chinese older adults with MCCs is lacking.

What were the main findings?

Findings from deductive content analysis largely confirmed published work in Western literature on stressors that complicated self-care, including symptom burdens, financial strains, social disconnection, caregiving responsibilities and major life events. Findings from reflexive thematic analysis extended current literature by identifying three culturally relevant stressors in older adults with MCCs in China: intergenerational obligations and commitments, ambivalence about receiving care and worries about potential problems.

Where and on whom will the research have an impact?

The research will have an impact on guiding nurses' assessment of culturally relevant stressors' impact on self-care for older adults with MCCs. In addition, findings could inform research and policy development to aim at mitigating the impact of culturally based stressors on self-care.

Reporting Method

This study adhered to the Standards for Reporting Qualitative Research (SRQR) guideline checklist.

Patient or Public Contribution

During the member-checking process, the validation of findings for accuracy was carried out by 10 participants, who also found resonance between these findings and their own experiences.

Randomised controlled trial combining vitamin E-functionalised chocolate with physical exercise to reduce the risk of protein-energy malnutrition in predementia aged people: study protocol for Choko-Age

Por: Pedrinolla · A. · Isanejad · M. · Antognelli · C. · Bartolini · D. · Borras · C. · Cavedon · V. · Di Sante · G. · Migni · A. · Mas-Bargues · C. · Milanese · C. · Baschirotto · C. · Modena · R. · Pistilli · A. · Rende · M. · Schena · F. · Stabile · A. M. · Telesa · N. V. · Tortorella · S.
Objective

Protein–energy malnutrition and the subsequent muscle wasting (sarcopenia) are common ageing complications. It is knowing to be also associated with dementia. Our programme will test the cytoprotective functions of vitamin E combined with the cortisol-lowering effect of chocolate polyphenols (PP), in combination with muscle anabolic effect of adequate dietary protein intake and physical exercise to prevent the age-dependent decline of muscle mass and its key underpinning mechanisms including mitochondrial function, and nutrient metabolism in muscle in the elderly.

Methods and analysis

In 2020, a 6-month double-blind randomised controlled trial in 75 predementia older people was launched to prevent muscle mass loss, in respond to the ‘Joint Programming Initiative A healthy diet for a healthy life’. In the run-in phase, participants will be stabilised on a protein-rich diet (0.9–1.0 g protein/kg ideal body weight/day) and physical exercise programme (high-intensity interval training specifically developed for these subjects). Subsequently, they will be randomised into three groups (1:1:1). The study arms will have a similar isocaloric diet and follow a similar physical exercise programme. Control group (n=25) will maintain the baseline diet; intervention groups will consume either 30 g/day of dark chocolate containing 500 mg total PP (corresponding to 60 mg epicatechin) and 100 mg vitamin E (as RRR-alpha-tocopherol) (n=25); or the high polyphenol chocolate without additional vitamin E (n=25). Muscle mass will be the primary endpoint. Other outcomes are neurocognitive status and previously identified biomolecular indices of frailty in predementia patients. Muscle biopsies will be collected to assess myocyte contraction and mitochondrial metabolism. Blood and plasma samples will be analysed for laboratory endpoints including nutrition metabolism and omics.

Ethics and dissemination

All the ethical and regulatory approvals have been obtained by the ethical committees of the Azienda Ospedaliera Universitaria Integrata of Verona with respect to scientific content and compliance with applicable research and human subjects’ regulation. Given the broader interest of the society toward undernutrition in the elderly, we identify four main target audiences for our research activity: national and local health systems, both internal and external to the project; targeted population (the elderly); general public; and academia. These activities include scientific workshops, public health awareness campaigns, project dedicated website and publication is scientific peer-review journals.

Trial registration number

NCT05343611.

Making the BEST decision-the BESTa project development, implementation and evaluation of a digital Decision Aid in Swedish cancer screening programmes- a description of a research project

by Kaisa Fritzell, Berith Hedberg, Anke Woudstra, Anna Forsberg, Marika Sventelius, Anders Kottorp, Anna Jervaeus

Background

Sweden has a long tradition of organized national population-based screening programmes. Participation rates differ between programmes and regions, being relatively high in some groups, but lower in others. To ensure an equity perspective on screening, it is desirable that individuals make an informed decision based on knowledge rather than ignorance, misconceptions, or fear. Decision Aids (DAs) are set to deliver information about different healthcare options and help individuals to visualize the values associated with each available option. DAs are not intended to guide individuals to choose one option over another. The advantage of an individual Decision Aid (iDA) is that individuals gain knowledge about cancer and screening by accessing one webpage with the possibility to communicate with health professionals and thereafter make their decision regarding participation. The objective is therefore to develop, implement and evaluate a digital iDA for individuals invited to cancer screening in Sweden.

Methods

This study encompasses a process-, implementation-, and outcome evaluation. Multiple methods will be applied including focus group discussions, individual interviews and the usage of the think aloud technique and self-reported questionnaire data. The project is based on The International Patient Decision Aid Standards (IPDAS) framework and the proposed model development process for DAs. Individuals aged 23–74, including women (the cervical-, breast- and CRC screening module) and men (the CRC screening module), will be included in the developmental process. Efforts will be made to recruit participants with self-reported physical and mental limitations, individuals without a permanent residence and ethnic minorities.

Discussion

To the best of our knowledge, the present study is the first attempt aimed at developing an iDA for use in the Swedish context. The iDA is intended to facilitate shared decision making about participation in screening. Furthermore, the iDA is expected to increase knowledge and raise awareness about cancer and cancer screening.

Patient or public contribution

Lay people are involved throughout the whole development and implementation process of the digital DA.

Trial registration

NCT05512260.

Cuidado de la familia al niño en una Unidad de Terapia Intensiva Pediátrica

Este estudio tiene el objetivo de conocer el cuidado dispensado por el familiar al niño internado en la Unidad de Terapia Intensiva Pediátrica (UTIP). Se trata de una investigación descriptiva y exploratoria con abordaje cualitativo, desarrollada en una UTIP de un hospital del sur de Rio Grande do Sul / Brasil. Participaron 15 familiares cuidadores de niños. La recolección ocurrió entre diciembre / 2017 a enero / 2018, por medio de una entrevista semiestructurada que ocurrió después de la aprobación del Comité de Ética en Investigación de la Facultad de Medicina de la Universidad Federal de Pelotas (UFPel), bajo el parecer nº 2.416.925. Los datos fueron interpretados según el análisis de contenido temático. Se elaboró ​​dos categorías: el cuidado prestado por los familiares dentro de una UTIP; Relación establecida por el equipo de salud de la UTIP con el familiar cuidador y el niño. La familia ofrece al niño un cuidado basado en el amor, cariño y calidez, expuestos al realizar acciones como cambiar los pañales, auxiliar en el baño y en curativos. De la misma forma el cuidado recibido por los familiares por parte del equipo de salud se mostró importante para facilitar el proceso de adaptación a la situación vivida y la continuidad del cuidado del familiar al niño.

ProFertil study protocol for the investigation of gonadotropin-releasing hormone agonists (GnRHa) during chemotherapy aiming at fertility protection of young women and teenagers with cancer in Sweden--a phase III randomised double-blinded placebo-controll

Por: Rodriguez-Wallberg · K. A. · Nilsson · H. P. · Bergh · J. · Malmros · J. · Ljungman · P. · Foukakis · T. · Stragliotto · C. L. · Friman · E. I. · Linderholm · B. · Valachis · A. · Andersson · A. · Harrysson · S. · Vennström · L. · Frisk · P. · Mörse · H. · Eloranta · S.
Background

Gonadotropin-releasing hormone agonists (GnRHa) cotreatment used to transiently suppress ovarian function during chemotherapy to prevent ovarian damage and preserve female fertility is used globally but efficacy is debated. Most clinical studies investigating a beneficial effect of GnRHa cotreatment on ovarian function have been small, retrospective and uncontrolled. Unblinded randomised studies on women with breast cancer have suggested a beneficial effect, but results are mixed with lack of evidence of improvement in markers of ovarian reserve. Unblinded randomised studies of women with lymphoma have not shown any benefit regarding fertility markers after long-term follow-up and no placebo-controlled study has been conducted so far. The aim of this study is to investigate if administration of GnRHa during cancer treatment can preserve fertility in young female cancer patients in a double-blind, placebo-controlled clinical trial.

Methods and analysis

A prospective, randomised, double-blinded, placebo-controlled, phase III study including 300 subjects with breast cancer. In addition, 200 subjects with lymphoma, acute leukemias and sarcomas will be recruited. Women aged 14–42 will be randomised 1:1 to treatment with GnRHa (triptorelin) or placebo for the duration of their gonadotoxic chemotherapy. Follow-up until 5 years from end of treatment (EoT). The primary endpoint will be change in anti-Müllerian hormone (AMH) recovery at follow-up 12 months after EoT, relative to AMH levels at EoT, comparing the GnRHa group and the placebo group in women with breast cancer.

Ethics and dissemination

This study is designed in accordance with the principles of Good Clinical Practice (ICH-GCP E6 (R2)), local regulations (ie, European Directive 2001/20/EC) and the ethical principles of the Declaration of Helsinki. Within 6 months of study completion, the results will be analysed and the study results shall be reported in the EudraCT database.

Study registration

The National Institutional review board in Sweden dnr:2021–03379, approval date 12 October 2021 (approved amendments 12 June 2022, dnr:2022-02924-02 and 13 December 2022, dnr:2022-05565-02). The Swedish Medical Product Agency 19 January 2022, Dnr:5.1-2021-98927 (approved amendment 4 February 2022). Manufacturing authorisation for authorised medicinal products approved 6 December 2021, Dnr:6.2.1-2020-079580. Stockholm Medical Biobank approved 22 June 2022, RBC dnr:202 253.

Trial registration number

NCT05328258; EudraCT number:2020-004780-71.

A cohort study on the biochemical and haematological parameters of Italian blood donors as possible risk factors of COVID-19 infection and severe disease in the pre- and post-Omicron period

by Chiara Marraccini, Lucia Merolle, Davide Schiroli, Agnese Razzoli, Gaia Gavioli, Barbara Iotti, Roberto Baricchi, Marta Ottone, Pamela Mancuso, Paolo Giorgi Rossi

To investigate the association between biochemical and blood parameters collected before the pandemic in a large cohort of Italian blood donors with the risk of infection and severe disease. We also focused on the differences between the pre- and post-Omicron spread in Italy (i.e., pre- and post-January 01, 2022) on the observed associations. We conducted an observational cohort study on 13750 blood donors was conducted using data archived up to 5 years before the pandemic. A t-test or chi-squared test was used to compare differences between groups. Hazard ratios with 95% confidence intervals for SARS-CoV-2 infection and severe disease were estimated using Cox proportional hazards models. Subgroup analyses stratified by sex, age and epidemic phase of first infection (pre- and post-Omicron spread) were examined. We confirmed a protective effect of groups B and O, while groups A and AB had a higher likelihood of infection and severe disease. However, these associations were only significant in the pre-Omicron period. We found an opposite behavior after Omicron spread, with the O phenotype having a higher probability of infection. When stratified by variant, A antigen appeared to protect against Omicron infection, whereas it was associated with an increased risk of infection by earlier variants. We were able to stratify for the SARS CoV-2 dominant variant, which revealed a causal association between blood group and probability of infection, as evidenced by the strong effect modification observed between the pre- and post-Omicron spread. The mechanism by which group A acts on the probability of infection should consider this strong effect modification.
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