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Hoy — Abril 19th 2024Tus fuentes RSS

Linking genetic counseling communication skills to patient outcomes and experiences using a community-engagement and provider-engagement approach: research protocol for the GC-PRO mixed methods sequential explanatory study

Por: Fisher · E. R. · Cragun · D. · Dedrick · R. F. · Lumpkins · C. Y. · Ramirez · M. · Kaphingst · K. A. · Petersen · A. · MacFarlane · I. M. · Redlinger-Grosse · K. · Shire · A. · Culhane-Pera · K. A. · Zierhut · H. A.
Introduction

In over 50 years since the genetic counseling (GC) profession began, a systematic study of GC communication skills and patient-reported outcomes in actual sessions across multiple clinical specialties has never been conducted. To optimize GC quality and improve efficiency of care, the field must first be able to comprehensively measure GC skills and determine which skills are most critical to achieving positive patient experiences and outcomes. This study aims to characterise GC communication skills using a novel and pragmatic measure and link variations in communication skills to patient-reported outcomes, across clinical specialties and with patients from diverse backgrounds in the USA. Our community-engagement and provider-engagement approach is crucial to develop recommendations for quality, culturally informed GC care, which are greatly needed to improve GC practice.

Methods and analysis

A mixed methods, sequential explanatory design will be used to collect and analyze: audio-recorded GC sessions in cancer, cardiac, and prenatal/reproductive genetic indications; pre-visit and post-visit quantitative surveys capturing patient experiences and outcomes and post-visit qualitative interview data. A novel, practical checklist will measure GC communication skills. Coincidence analysis will identify patterns of GC skills that are consistent with high scores on patient-reported measures. Two-level, multilevel models will be used to evaluate how GC communication skills and other session/patient characteristics predict patient-reported outcomes. Four community advisory boards (CABs) and a genetic counselor advisory board will inform the study design and analysis.

Ethics and dissemination

This study has been approved by the single Institutional Review Board of the University of Minnesota. This research poses no greater than minimal risk to participants. Results from this study will be shared through national and international conferences and through community-based dissemination as guided by the study’s CABs. A lay summary will also be disseminated to all participants.

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Development of a competency framework for advanced practice nurses: A co‐design process

Abstract

Aims

The aim of the study was to develop a comprehensive competency framework for advanced practice nurses in Belgium.

Design

A co-design development process was conducted.

Methods

This study consisted of two consecutive stages (November 2020–December 2021): (1) developing a competency framework for advanced practice nurses in Belgium by the research team, based on literature and (2) group discussions or interviews with and written feedback from key stakeholders. 11 group discussions and seven individual interviews were conducted with various stakeholder groups with a total of 117 participants.

Results

A comprehensive competency framework containing 31 key competencies and 120 enabling competencies was developed based on the Canadian Medical Education Directions for Specialists Competency Framework. These competencies were grouped into seven roles: clinical expert and therapist, organizer of quality care and leader in innovation, professional and clinical leader, collaborator, researcher, communicator and health promoter.

Conclusion

The developed competency framework has resemblance to other international frameworks. This framework emphasized the independent role of the advanced practice nurse and provided guidance in a clear task division and delegation to other professionals. It can provide a solid foundation for delivering high-quality, patient-centred care by advanced practice nurses in the years to come.

Implications for the profession

This competency framework can guide further development of advanced practice nursing education in Belgium and represents a starting point for future evaluation of its feasibility and usability in education and clinical practice. Advanced practice nurses and healthcare managers can also use the framework as an instrument for personal and professional development, performance appraisal, and further alignment of these function profiles in clinical practice. Finally, this framework can inform and guide policymakers towards legal recognition of advanced practice nursing in Belgium and inspire the development of advanced practice nursing profiles in countries where these profiles are still emerging.

Impact

What problem did the study address? The absence of a detailed competency framework for advanced practice nurses complicates legal recognition, role clarification and implementation in practice in Belgium. A rigorously developed competency framework could clarify which competencies to integrate in future advanced practice nursing education, mentorship programs and practice.

What were the main findings? The competency framework outlined seven roles for advanced practice nurses: clinical expert and therapist, organizer of quality care and leader in innovation, professional and clinical leader, collaborator, researcher, communicator, and health promoter. Differentiation from other expert nursing profiles and clinical autonomy of advanced practice nurses were pivotal.

Where and on whom will the research have impact? The comprehensive competency framework for advanced practice nurses and the collaborative methodology used can inspire other countries where these profiles are still emerging. The competency framework can be used as an instrument for role clarification, performance appraisals, continuous professional development, and professional (e-)portfolios. The competency framework can guide policymakers when establishing Belgian’s legal framework for advanced practice nurses.

Reporting method

The authors have adhered to CONFERD-HP: recommendations for reporting COmpeteNcy FramEwoRk Development in health professions.

Patient or public contribution

No patient or public contribution in the design of the study. A patient advisory panel commented on the developed competency framework.

Prospective cohort study of genomic newborn screening: BabyScreen+ pilot study protocol

Por: Lunke · S. · Bouffler · S. E. · Downie · L. · Caruana · J. · Amor · D. J. · Archibald · A. · Bombard · Y. · Christodoulou · J. · Clausen · M. · De Fazio · P. · Greaves · R. F. · Hollizeck · S. · Kanga-Parabia · A. · Lang · N. · Lynch · F. · Peters · R. · Sadedin · S. · Tutty · E. · Eggers
Introduction

Newborn bloodspot screening (NBS) is a highly successful public health programme that uses biochemical and other assays to screen for severe but treatable childhood-onset conditions. Introducing genomic sequencing into NBS programmes increases the range of detectable conditions but raises practical and ethical issues. Evidence from prospectively ascertained cohorts is required to guide policy and future implementation. This study aims to develop, implement and evaluate a genomic NBS (gNBS) pilot programme.

Methods and analysis

The BabyScreen+ study will pilot gNBS in three phases. In the preimplementation phase, study materials, including education resources, decision support and data collection tools, will be designed. Focus groups and key informant interviews will also be undertaken to inform delivery of the study and future gNBS programmes. During the implementation phase, we will prospectively recruit birth parents in Victoria, Australia, to screen 1000 newborns for over 600 severe, treatable, childhood-onset conditions. Clinically accredited whole genome sequencing will be performed following standard NBS using the same sample. High chance results will be returned by genetic healthcare professionals, with follow-on genetic and other confirmatory testing and referral to specialist services as required. The postimplementation phase will evaluate the feasibility of gNBS as the primary aim, and assess ethical, implementation, psychosocial and health economic factors to inform future service delivery.

Ethics and dissemination

This project received ethics approval from the Royal Children’s Hospital Melbourne Research Ethics Committee: HREC/91500/RCHM-2023, HREC/90929/RCHM-2022 and HREC/91392/RCHM-2022. Findings will be disseminated to policy-makers, and through peer-reviewed journals and conferences.

National survey on understanding nursing academics' perspectives on digital health education

Abstract

Aim

This study explored the knowledge and confidence levels of nursing academics in teaching both the theories and practical skills of digital health in undergraduate nursing programs.

Design

A cross-sectional study.

Methods

A structured online survey was distributed among nursing academics across Australian universities. The survey included two sections: (1) the participants' demographics and their nursing and digital health teaching experience; (2) likert scales asking the participants to rate their knowledge and confidence to teach the theories and practical skills of four main themes; digital health technologies, information exchange, quality and digital professionalism.

Results

One hundred and nineteen nursing academics completed part one, and 97 individuals completed part two of the survey. Only 6% (n = 5) of the participants reported having formal training in digital health. Digital health was mainly taught as a module (n = 57, 45.9%), and assessments of theory or practical application of digital health in the nursing curriculum were uncommon, with 79 (69.9%) responding that there was no digital health assessment in their entry to practice nursing programs. Among the four core digital health themes, the participants rated high on knowledge of digital professionalism (22.4% significant knowledge vs. 5.9% no knowledge) but low on information exchange (30% significant knowledge vs. 28.3% no knowledge). Statistically significant (p < .001) associations were found between different themes of digital health knowledge and the level of confidence in teaching its application. Nursing academics with more than 15 years of teaching experience had a significantly higher level of knowledge and confidence in teaching digital health content compared with those with fewer years of teaching experience.

Conclusion

There is a significant gap in nursing academics' knowledge and confidence to teach digital health theory and its application in nursing. Nursing academics need to upskill in digital health to prepare the future workforce to be capable in digitally enabled health care settings.

Implications for the Profession

Nursing academics have a limited level of digital knowledge and confidence in preparing future nurses to work in increasingly technology-driven health care environments. Addressing this competency gap and providing sufficient support for nursing academics in this regard is essential.

Impact

What problem did the study address? Level of knowledge and confidence among nursing academics to teach digital health in nursing practice. What were the main findings? There is a significant gap in nursing academics' knowledge and confidence to teach digital health theory and its application in nursing. Where and on whom will the research have an impact? Professional nursing education globally.

Reporting Method

The STROBE guideline was used to guide the reporting of the study.

Patient or Public Contribution

The call for participation from nursing academics across Australia provided an introductory statement about the project, its aim and scope, and the contact information of the principal researcher. A participant information sheet was shared with the call providing a detailed explanation of participation. Nursing academics across Australia participated in the survey through the link embedded in the participation invite.

The prevalence of incivility in hospitals and the effects of incivility on patient safety culture and outcomes: A systematic review and meta‐analysis

Abstract

Aim

Workplace incivility is a barrier to safe and high-quality patient care in nursing workplaces and more broadly in tertiary hospitals. The present study aims to systematically review the existing evidence to provide a comprehensive understanding of the prevalence of co-worker incivility experienced and witnessed by nurses and other healthcare professionals, the effects of incivility on patient safety culture (PSC) and patient outcomes, and the factors which mediate the relationship between incivility and patient safety.

Methods

A systematic review with narrative synthesis and meta-analysis was undertaken to synthesize the data from 41 studies.

Data Sources

Databases searched included MEDLINE, PubMed, SCOPUS, CINAHL, PsycInfo, ProQuest, Emcare and Embase. Searches were conducted on 17 August 2021 and repeated on 15 March 2023.

Results

The pooled prevalence of experienced incivility was 25.0%. The pooled prevalence of witnessed incivility was 30.1%. Workplace incivility was negatively associated with the PSC domains of teamwork, reporting patient safety events, organization learning/improvement, management support for safety, leadership, communication openness and communication about error. The composite pooled effect size of incivility on these domains of PSC was OR = 0.590, 95% CI [0.515, 0.676]. Workplace incivility was associated with a range of patient safety outcomes (PSOs) including near misses, adverse events, reduced procedural and diagnostic performance, medical error and mortality. State depletion, profession, psychological responses to incivility, information sharing, help seeking, workload and satisfaction with organizational communication were found to mediate the relationship between incivility and patient safety.

Conclusion

Experienced and witnessed incivility is prevalent in tertiary hospitals and has a deleterious effect on PSC and PSOs. A better understanding of the mechanisms of this relationship will support the development of interventions aimed at reducing both incivility and patient harm.

Implications for the Profession and/or Patient Care Impact

This study quantifies the effect of incivility on PSC and outcomes. It provides support that interventions focusing on incivility are a valuable mechanism for improving patient care. It guides intervention design by highlighting which domains of PSC are most associated with incivility. It explores the profession-specific experiences of workplace incivility.

Reporting Method

This report adheres to PRISMA reporting guidelines.

Patient or Public Contribution

No patient or public contribution. The focus of this study is the nursing and healthcare workforce, therefore, patient or public involvement not required.

Contemporary national outcomes of hyperbaric oxygen therapy in necrotizing soft tissue infections

by William Toppen, Nam Yong Cho, Sohail Sareh, Anders Kjellberg, Anthony Medak, Peyman Benharash, Peter Lindholm

Background

The role of hyperbaric oxygen therapy (HBOT) in necrotizing soft tissue infections (NSTI) is mainly based on small retrospective studies. A previous study using the 1998–2009 National Inpatient Sample (NIS) found HBOT to be associated with decreased mortality in NSTI. Given the argument of advancements in critical care, we aimed to investigate the continued role of HBOT in NSTI.

Methods

The 2012–2020 National Inpatient Sample (NIS) was queried for NSTI admissions who received surgery. 60,481 patients between 2012–2020 were included, 600 ( Results

Age, gender, and comorbidities were similar between the two groups. On bivariate comparison, the HBOT group had lower mortality rate ( Conclusions

After correction for differences, HBOT was associated with decreased mortality, amputations, and non-home discharges in NSTI with the tradeoff of increase to costs and length of stay.

Towards explainable interaction prediction: Embedding biological hierarchies into hyperbolic interaction space

by Domonkos Pogány, Péter Antal

Given the prolonged timelines and high costs associated with traditional approaches, accelerating drug development is crucial. Computational methods, particularly drug-target interaction prediction, have emerged as efficient tools, yet the explainability of machine learning models remains a challenge. Our work aims to provide more interpretable interaction prediction models using similarity-based prediction in a latent space aligned to biological hierarchies. We investigated integrating drug and protein hierarchies into a joint-embedding drug-target latent space via embedding regularization by conducting a comparative analysis between models employing traditional flat Euclidean vector spaces and those utilizing hyperbolic embeddings. Besides, we provided a latent space analysis as an example to show how we can gain visual insights into the trained model with the help of dimensionality reduction. Our results demonstrate that hierarchy regularization improves interpretability without compromising predictive performance. Furthermore, integrating hyperbolic embeddings, coupled with regularization, enhances the quality of the embedded hierarchy trees. Our approach enables a more informed and insightful application of interaction prediction models in drug discovery by constructing an interpretable hyperbolic latent space, simultaneously incorporating drug and target hierarchies and pairing them with available interaction information. Moreover, compatible with pairwise methods, the approach allows for additional transparency through existing explainable AI solutions.

First clinical evaluation of the safety and efficacy of tarumase for the debridement of venous leg ulcers

Abstract

We report the first clinical evaluation of a new enzymatic wound debridement product containing tarumase in venous leg ulcer patients. As a first-in-human study, this was a prospective, open-label, multi-centre, dose escalation study across five dose cohorts and involving a total of 43 patients treated three times weekly for up to 4 weeks (12 applications). The primary and secondary endpoints of the study were to assess the systemic safety, local tolerability, and early proof of concept both for wound debridement and healing. Results indicated that the tarumase enzyme was well tolerated when applied topically to wounds, with no indications of systemic absorption, no evidence of antibody generation, and no systemic effects on coagulation pathways. Locally, there was no evidence of pain on application, no local itching, no increases in erythema, oedema, exudate or bleeding and only a few treatment emergent adverse events were reported. As the concentration of tarumase was escalated, trends towards faster and improved effectiveness of wound debridement were observed, especially in patients with significant slough at baseline. Trends towards faster rates of healing were also noted based on observations of increased granulation tissue, increased linear healing and reduction in surface area over the 4-week treatment period.

ATME--Needs, requirements and cross-sectoral patient journeys of patients with out-of-hospital mechanical ventilation and intensive care in outpatient settings: study protocol for an observational study

Por: Knizia · N.-A. · Hirschler · J. · Stegbauer · C. · Schwinger · A. · Büscher · A. · Englert · N. · Peters · L. · Bayarassou · H. A. · Mallmann · L. · Willms · G.
Introduction

An increasing number of tracheotomised and/or ventilated patients with high-cost out-of-hospital intensive care needs and, at the same time, a decreasing number of healthcare professionals inevitably lead to challenges in the care of this patient population. In addition, little is known about this population, their health restrictions, needs, patient journeys, care structures and processes. The project ‘Needs, requirements and cross-sectoral care pathways of out-of-hospital ventilated intensive care patients’ (ATME) aims to analyse these aspects and explore current care structures to inform further development of care in line with patients’ needs and requirements.

Methods and analysis

Qualitative and quantitative methods will be used. In preparation of a semistandardised survey, exploratory interviews will be conducted with tracheotomised and/or ventilated patients with out-of-hospital intensive care needs (TVPOI) (n=15), nursing care providers (n=30), outpatient medical centres, as well as outpatient medical, medical technology and therapeutic care providers (n=35). Three semistandardised survey questionnaires for TVPOI (n=2,000) will be developed and conducted with nursing care facilities (n=250) and outpatient medical centres for mechanical ventilation (n=25). Content analyses will be conducted for qualitative data; survey data will be analysed descriptively. In addition, healthcare claims data will be analysed descriptively to provide information on patient journeys. Three result workshops and one consensus conference will be carried out with representatives of the relevant target groups to analyse the suitability of care structures and to develop recommendations for action to improve TVPOI.

Ethics and dissemination

The ATME study received a positive vote from the Ethics Committee of the Osnabrück University of Applied Sciences and is registered in ‘Deutsches Register Klinischer Studien (DRKS)’ (registration number: DRKS00030891). The study results will be presented at national conferences and in relevant peer-reviewed journals. Additionally, study results will be published by the funding institution (the Innovation Committee of the Federal Joint Committee) on their website.

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.

Experiences of older vulnerable people with ischemic heart disease and their peer mentors: A qualitative process evaluation

Abstract

Aim

To understand the content and context of a realized peer mentor intervention, and to explore how mentors and mentees experienced the intervention.

Design

The study was designed as a qualitative process evaluation of a 24-week peer mentor intervention.

Methods

Semi-structured individual interviews were conducted from November 2021 to May 2022 in a purposeful sample of older vulnerable people with ischemic heart disease, referred to as mentees (n = 13), and their peer mentors (n = 12). Thematic analysis was used to analyse, categorize and interpret interview data.

Results

Five themes captured the content and context of the peer mentor intervention as experienced by mentors and mentees. ‘Takes one to know one’, stressing the importance of the mentor–mentee matching process; ‘Varying demand for mentors’, illustrating the difficulties in predicting who has the greatest need for mentoring; ‘Varying degree of familiarity’, describing the mentor–mentee relationship as a continuum from formal mentor to informal friend; ‘Putting the patient first’, illustrating how mentors support mentees based on their personal experiences of successful recovery while letting the mentee set the pace and goals; and ‘Varying view of success’, showing how intervention success is perceived differently by mentors and mentees.

Conclusions

The study provides new knowledge on how and under what contextual circumstances a mentor intervention works. These findings are important for the implementation of future peer mentor interventions to achieve successful peer mentor support.

Implications and Impact

Non-attendance and drop-out from the cardiac rehabilitation program are prevalent problems among older vulnerable people with cardiovascular disease. This study describes a low-cost peer mentor intervention that can support this group of patients.

Reporting Method

Standards for reporting qualitative research (SRQR) guided our study.

Patient or Public Contribution

A board of cardiovascular patients have contributed to the development and implementation of the intervention being evaluated.

Task redistribution from general practitioners to nurses in acute infection care: A prospective cohort study

Abstract

Aim

To examine the impact of implementing nurse-led consultations compared to physician-led consultations on the frequency of follow-up contacts within 14 days following an acute infectious consultation.

Design

Monocentric, prospective cohort study.

Methods

The study was conducted in a multidisciplinary, capitation-based general practice in Belgium. Through analysis of patient files, the number of follow-up contacts within 14 days after an infection consultation was investigated to determine any difference between physician-led or nurse-led consultations. Secondary outcomes included pharmacological interventions and the prescribing behaviour of medical leave certificates.

Results

A total of 352 consultations were analysed, of which 174 conducted by physicians and 178 by nurses. No significant difference was found in the number of follow-up contacts. However, the probability of a pharmacological intervention by a physician was revealed to be significantly higher. The presence or absence of such pharmacological intervention did not significantly influence the number of follow-up contacts.

Conclusion

This study demonstrates that nurses can be safely and efficiently utilized in acute infection care within a general practice setting. Although these results are promising, more extensive research is needed which incorporates the experiences of patients and healthcare providers. Furthermore, it is advisable to consider the experience and education of the nurses and incorporate them into the analyses.

Impact

This study addressed the high workload on general practitioners by researching a task shift in the acute infectious, primary health care. The results demonstrate the feasibility of this task shift, which may have an impact on primary health care professionals (whose workload may be reorganized), as well as on patients for whom primary care may become more accessible.

Patient or Public Contribution

This study includes direct patient data from people who presented themselves with acute infectious complaints in a primary healthcare practice.

Non-invasive cumulus cell analysis can be applied for oocyte ranking and is useful for countries with legal restrictions on embryo generation or freezing

by Tom Adriaenssens, Inge Van Vaerenbergh, Lisbet Van Landuyt, Greta Verheyen, Michaël De Brucker, Michel Camus, Peter Platteau, Michel De Vos, Maria Reis, Elien Van Hecke, André Rosenthal, Johan Smitz

Research question

Can a strategy for scoring oocyte quality, based on cumulus cell (CC) gene expression, prioritize oocytes with the highest implantation potential, while limiting the number of embryos to be processed in culture and the number of supernumerary embryos to be vitrified?

Design

An interventional, blinded, prospective cohort study was retrospectively analyzed. In the original study, patients underwent a fresh Day3 single embryo transfer with embryos ranked based on morphology and CC gene expression (Aurora Test). The additional ranking of the embryos with the Aurora Test resulted in significant higher clinical pregnancy and live birth rates. Now it is investigated if the Aurora Test ranking could be applied to select oocytes. The effect of an Aurora Test based restriction to 2 and 3 2PN or MII oocytes on clinical pregnancy and other outcomes, was analyzed in two subsets of patients with all 2PN (n = 83) or all MII oocytes (n = 45) ranked.

Results

Considering only the top three ranked 2PN oocytes, 95% of the patients would have received a fresh SET on Day3 resulting in 65% clinical pregnancies. This was not different from the pregnancy rate obtained in a strategy using all oocytes but significantly reduced the need for vitrification of supernumerary embryos by 3-fold. Considering only top-ranked MII oocytes gave similar results.

Conclusions

In countries with legal restrictions on freezing of embryos, gene expression of CC can be used for the selective processing of oocytes and would thus decrease the twin pregnancy rate and workload, especially for embryo morphology scoring and transfers as the handling and processing of lower competence oocytes is prevented, while improving the ART outcome.

A non-lethal stable isotope analysis of valued freshwater predatory fish using blood and fin tissues as alternatives to muscle tissue

by Lukáš Vejřík, Ivana Vejříková, Zuzana Sajdlová, Luboš Kočvara, Tomáš Kolařík, Daniel Bartoň, Tomáš Jůza, Petr Blabolil, Jiří Peterka, Martin Čech, Mojmír Vašek

Stable isotope analysis (SIA) is widely used to study trophic ecology and food webs in aquatic ecosystems. In the case of fish, muscle tissue is generally preferred for SIA, and the method is lethal in most cases. We tested whether blood and fin clips can be used as non-lethal alternatives to muscle tissue for examining the isotopic composition of two freshwater predatory fish, European catfish (Silurus glanis) and Northern pike (Esox lucius), species of high value for many freshwater systems as well as invasive species in many others. Blood samples from the caudal vein, anal fin clips, and dorsal muscle obtained by biopsy punch were collected from four catfish and pike populations (14–18 individuals per population). Subsequently, these samples were analyzed for δ13C and δ15N. The effects of alternative tissues, study site, and fish body mass on the isotopic offset were investigated. Both species showed a correlation between the isotopic offset and the tissue type, as well as the study site, but no significant relationship with the body mass. The isotopic offsets between tissues were used to calculate the conversion equations. The results demonstrated that both blood and fin clips are suitable and less invasive alternative to muscle in SIA studies focused on European catfish and Northern pike. Blood provided better correspondence to muscle isotope values. However, our results clearly demonstrated that isotopic offsets between tissues vary significantly among populations of the same species. Therefore, obtaining a muscle biopsy from several individuals in any population is advisable to gain initial insights and establish a possible population-specific inter-tissue conversion.

The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial

by Andreas Michalsen, Kim Goldenstein, Peter Kardos, Ludger Klimek, Jürgen Palm, Dajana Parganlija, Johannes Stöckl

Introduction

Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior to CC onset.

Methods

Out of 522 adults enrolled in our phase IV, open-label, non-randomized, exploratory clinical trial (EudraCT No. 2020-000860-51), 329 developed a CC and used 200 mg cineole (Soledum®, CNL-1976) t.i.d. for max. 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11).

Results

Comparing three strata based on time to treatment (≤ 12 h, > 12 to ≤ 24 h and > 24 h), earliest treatment resulted in lowest AUC-WURSS (Spearman correlation coefficient of 0.36) and reduced the overall burden of disease by 38% (p Conclusions

Early intervention shows clinical benefits relevant for the effective treatment of CC with cineole.

Organization of Hannover Skin Bank: Sterile culture and procurement protocols for viable cryopreserved allogeneic skin grafts of living donors

Abstract

Preserved allogeneic donor skin still represents one of the gold standard therapies in temporary wound coverage in severely burned patients or chronic wounds. Allogeneic skin grafts are currently commercially available as cryo- or glycerol-preserved allografts through skin tissue banks all over the world. Most of the skin tissue banks rely on human cadaveric skin donations. Due to the chronic shortage of human allogeneic transplants, such as skin, and increasing costs in the procurement of allografts from other skin tissue banks, Hannover Medical School has been building up its own skin tissue bank based on allogeneic skin grafts from living donors who underwent surgical treatment (i.e., body-contouring procedures, such as abdominioplasties). This article presents procedures and protocols for the procurement and processing of allogeneic skin grafts according to national legislation and European regulations and guidelines. Beside protocols, initial microbiological data regarding the sterility of the harvested grafts are presented. The results currently form the basis for further investigations as well as clinical applications. In summary, a microbiological testing and acceptance procedure is presented that ensures adequate patient safety and skin viability.

Optimisation of Organ Preservation treatment strategies in patients with rectal cancer with a good clinical response after neoadjuvant (chemo)radiotherapy: Additional contact X-ray brachytherapy versus eXtending the observation period and local excision (

Por: Geubels · B. M. · van Triest · B. · Peters · F. P. · Maas · M. · Beets · G. L. · Marijnen · C. A. M. · Custers · P. A. · Rutten · H. J. T. · Theuws · J. C. M. · Verrijssen · A.-S. E. · Cnossen · J. S. · Burger · J. W. A. · Grotenhuis · B. A.
Introduction

Standard treatment for patients with intermediate or locally advanced rectal cancer is (chemo)radiotherapy followed by total mesorectal excision (TME) surgery. In recent years, organ preservation aiming at improving quality of life has been explored. Patients with a complete clinical response to (chemo)radiotherapy can be managed safely with a watch-and-wait approach. However, the optimal organ-preserving treatment strategy for patients with a good, but not complete clinical response remains unclear. The aim of the OPAXX study is to determine the rate of organ preservation that can be achieved in patients with rectal cancer with a good clinical response after neoadjuvant (chemo)radiotherapy by additional local treatment options.

Methods and analysis

The OPAXX study is a Dutch multicentre study that investigates the efficacy of two additional local treatments aiming at organ preservation in patients with a good, but not complete response to neoadjuvant treatment (ie near-complete response or a small residual tumour mass

Ethics and dissemination

The trial protocol has been approved by the medical ethics committee of the Netherlands Cancer Institute (METC20.1276/M20PAX). Informed consent will be obtained from all participants. The trial results will be published in an international peer-reviewed journal.

Trial registration number

NCT05772923.

Genital tract infections, the vaginal microbiome and gestational age at birth among pregnant women in South Africa: a cohort study protocol

Por: Gigi · R. M. S. · Mdingi · M. M. · Jung · H. · Claassen-Weitz · S. · Bütikofer · L. · Klausner · J. D. · Muzny · C. A. · Taylor · C. M. · van de Wijgert · J. H. H. M. · Peters · R. P. H. · Low · N.
Introduction

Preterm birth complications are the most common cause of death in children under 5 years. The presence of multiple microorganisms and genital tract inflammation could be the common mechanism driving early onset of labour. South Africa has high levels of preterm birth, genital tract infections and HIV infection among pregnant women. We plan to investigate associations between the presence of multiple lower genital tract microorganisms in pregnancy and gestational age at birth.

Methods and analysis

This cohort study enrols around 600 pregnant women at one public healthcare facility in East London, South Africa. Eligible women are ≥18 years and at Chlamydia trachomatis and Neisseria gonorrhoeae, with treatment if test results are positive. At these visits, additional vaginal specimens are taken for: PCR detection and quantification of Trichomonas vaginalis, Candida spp., Mycoplasma genitalium, M. hominis, Ureaplasma urealyticum and U. parvum; microscopy and Nugent scoring; and for 16S ribosomal RNA gene sequencing and quantification. Pregnancy outcomes are collected from a postnatal visit and birth registers. The primary outcome is gestational age at birth. Statistical analyses will explore associations between specific microorganisms and gestational age at birth. To explore the association with the quantity of microorganisms, we will construct an index of microorganism load and use mixed-effects regression models and classification and regression tree analysis to examine which combinations of microorganisms contribute to earlier gestational age at birth.

Ethics and dissemination

This protocol has approvals from the University of Cape Town Research Ethics Committee and the Canton of Bern Ethics Committee. Results from this study will be uploaded to preprint servers, submitted to open access peer-reviewed journals and presented at regional and international conferences.

Trial registration number

NCT06131749; Pre-results.

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.

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