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Adherence to PRISMA 2020 reporting guidelines and scope of systematic reviews published in nursing: A cross‐sectional analysis

Abstract

Introduction

Systematic reviews are considered the highest level of evidence that can help guide evidence-informed decisions in nursing practice, education, and even health policy. Systematic review publications have increased from a sporadic few in 1980s to more than 10,000 systematic reviews published every year and around 30,000 registered in prospective registries.

Methods

A cross-sectional design and a variety of data sources were triangulated to identify the journals from which systematic reviews would be evaluated for adherence to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 reporting guidelines and scope. Specifically, this study used the PRISMA 2020 reporting guidelines to assess the reporting of the introduction, methods, information sources and search strategy, study selection process, quality/bias assessments, and results and discussion aspects of the included systematic reviews.

Results

Upon review of the 215 systematic reviews published in 10 top-tier journals in the field of nursing in 2019 and 2020, this study identified several opportunities to improve the reporting of systematic reviews in the context of the 2020 PRISMA statement. Areas of priority for reporting include the following key areas: (1) information sources, (2) search strategies, (3) study selection process, (4) bias reporting, (5) explicit discussion of the implications to policy, and lastly, the need for (6) prospective protocol registration.

Discussion

The use of the PRISMA 2020 guidelines by authors, peer reviewers, and editors can help to ensure the transparent and detailed reporting of systematic reviews published in the nursing literature.

Clinical Relevance

Systematic reviews are considered strong research evidence that can guide evidence-based practice and even clinical decision-making. This paper addresses some common methodological and process issues among systematic reviews that can guide clinicians and practitioners to be more critical in appraising research evidence that can shape nursing practice.

COVID‐19 and beyond: A systematic review of adaptations to psychosocial support in oncology

Abstract

Aims

To understand the strategies used to continue providing psychosocial support to cancer patients during the pandemic, including outcomes and implications beyond the pandemic.

Design

A systematic review of original research.

Data Sources

ProQuest Health & Medicine, CINAHL Complete (via EBSCOhost), Scopus, and PubMed were searched for original work published between January 2020 and December 2022.

Methods

Abstract and title screening identified eligible articles for full-text review. Following a full-text review, data were extracted from eligible articles, and a risk of bias assessment was conducted. A synthesis without meta-analysis was performed.

Results

Thirty-four articles met the selection criteria. These articles provide evidence that systematic adaptations during the pandemic improved the assessment and screening of psychological needs and/or increased the number of clients accessing services. Additionally, while the pandemic was associated with decreased psychosocial well-being for cancer patients, five intervention studies reported improvements in psychosocial well-being. Barriers, strategies, and recommendations were described.

Conclusion

Adapting psychosocial support during a pandemic can be successful, achieved relatively quickly, and can increase the uptake of support for people experiencing cancer.

Implications for Patient Care

It is imperative that these adaptations continue beyond the pandemic to maximize adaptive psychosocial outcomes for a group vulnerable to ongoing mental health concerns.

Impact

While the COVID-19 pandemic was associated with increased psychosocial need for cancer patients, evidence in the review suggested that adaptations made to service delivery facilitated increased access for patients who may not previously have been able to access support. Additionally, improvements in psychosocial well-being were achieved. These findings are relevant for clinicians and decision-makers who fund and design psychosocial support services for cancer patients.

Reporting Method

The review was guided by PRISMA Guidelines and the SWiM Reporting Guideline.

Patient or Public Contribution

No patient or public contribution.

Strategies for incorporating evidence‐based practice into nurse residency programs: A scoping review

Abstract

Background

The American Nurses Credentialing Center's (ANCC's) Practice Transition Accreditation Program (PTAP) establishes standards for nurse residency programs to elevate and optimize the skills, knowledge, and attitudes of new nurses participating in nurse residency programs. Evidence-based practice (EBP) is foundational to providing safe nursing care. One of the National Academy of Medicine's (NAM's) 2020 goals stated that 90% of clinical decisions would be supported by the best available evidence to attain the best patient outcomes. Nurse residency programs can benefit from evidence-based strategies to develop EBP competencies in new nurses.

Aims

The purpose of this scoping review was to synthesize the literature around strategies for incorporating EBP into nurse residency programs across the United States.

Methods

This scoping review was informed by the JBI (formerly known as the Joanna Briggs Institute) methodology for scoping reviews. Searches were conducted by a health science librarian in PubMed and CINAHL with Full Text. Keywords and their synonyms, Medical Subject Headings (MeSH; PubMed), and Subject Headings (CINAHL with Full Text) were used. Covidence, a literature review management program, was used to organize the literature and manage the review. Title, abstract, and full-text reviews were completed within Covidence using three teams of two independent reviewers.

Results

Four hundred and thirty-eight citations were imported into Covidence. Ten articles were retained for the final review. Three strategies for incorporating EBP into nurse residency programs emerged from the literature: (1) exposure of nurse residents to existing organizational resources, (2) completion of online EBP modules, and (3) completion of an EBP project.

Linking Action to Evidence

The incorporation of EBP competencies in nurse residency programs aligns with NAM's and ANCC's goals, yet a paucity of evidence exists to guide curriculum development in nurse residency programs. This scoping review corroborates the need for further research to inform best practices for implementing EBP into nurse residency programs.

Patient-centered perspectives in diabetic retinopathy care: phenomenology and practice

Por: Raman · R. · Kumar · S.

Commentary on: Zhang M, Zhang C, Chen C, et al. The experience of diabetic retinopathy patients during hospital-to-home full-cycle care: a qualitative study. BMC Nurs. 2023 Mar 3;22(1):58. doi: 10.1186/s12912-023-01206-y.

Implications for practice and research

  • Consideration of patients' life experiences, which aids in examining their feelings and patient’ experiences.

  • Future research should further investigate the phenomenological approach in diverse healthcare contexts.

  • Context

    The transition from hospital to home treatment for patients with diabetic retinopathy (DR) is the subject of a study by Zhang and colleagues. The authors attempt to comprehend the substance of this phenomenon a shift towards patient-centric healthcare research by using a phenomenological method.1 Such first-hand experiences may help to close the gap between patient demands and medical practise, laying the groundwork for personalised and emphathetic care strategies.

    Methods

    The descriptive phenomenology method was used to implement this...

    The current state of knowledge on care for co‐occurring chronic pain and opioid use disorder: A scoping review

    Abstract

    Background and Aims

    Opioid use disorder often co-occurs with chronic pain but assessment and treatment of these co-occurring disorders is complex. This review aims to identify current treatments and delivery models for co-occurring chronic pain and opioid use disorder (OUD) documented in the scientific literature.

    Design

    Scoping review.

    Methods

    The review was conducted in six databases in June 2022 (no time limit): CINAHL, PsycINFO, Web of Science, Cochrane, PubMed and Embase. The PRISMA-ScR checklist was used to guide reporting.

    Results

    Forty-seven publications addressing the issue of co-occurring chronic pain and OUD management were included. Randomized controlled trials provide evidence for the effectiveness of opioid agonist treatments (OAT) such as methadone or buprenorphine/naloxone, as well as for combining OAT with Mindfulness-Oriented Recovery Enhancement or cognitive behavioural therapy. A number of other pharmacological treatments (opioid and nonopioid), nonpharmacological treatments (e.g. physiotherapy) and service delivery models (e.g. simultaneous treatment of comorbidities, interdisciplinary and interprofessional collaboration) are also underlined. In most cases, authors recommend a combination of strategies to meet patient needs.

    Conclusions

    The scoping review reveals gaps in evidence-based knowledge to effectively care for co-occurring chronic pain and OUD, but several experts recommend the uptake of known ‘best’ practices such as integrated treatment of the multiple biopsychosocial dimensions of the co-occurring disorders as well as collaborative interdisciplinary work.

    Clinical Relevance

    Improving services is dependent on alleviating barriers such as working in silos, the costs associated with nonpharmacological treatments, and the double stigma associated with pain in people with a substance use disorder.

    ‘We had conversations we wouldn't have had otherwise’—Exploring home‐dwelling people with dementia and family members' experiences of deliberating on ethical issues in a literature‐based intervention

    Abstract

    Aim

    To explore home-dwelling people with dementia and family members' perceptions of the feasibility and acceptability of an intervention using dementia-related literature excerpts to facilitate conversations on ethical issues related to living with dementia.

    Background

    Ethical issues in dementia care emerge throughout the illness. In the early stages, they may involve decisions about disclosing the illness to the family, shifting roles and responsibilities, and considerations of transitioning to a nursing home. Addressing ethical issues and providing adequate support to home-dwelling people with dementia and their families are often lacking.

    Design

    An exploratory-descriptive qualitative study.

    Methods

    We conducted eight interviews with 14 home-dwelling persons with dementia and their family caregivers. Six were dyadic interviews, and two were individual interviews with family caregivers. We analysed the interview data using template analysis. We adhered to the COREQ checklist in reporting this study.

    Results

    Using excerpts from dementia-related literature was a feasible and acceptable way of initiating discussions on ethical issues among home-dwelling persons with dementia and family caregivers. However, engaging the families of newly diagnosed individuals was challenging due to emotional distress. The intervention provided peer support, including identifying with others and sharing experiences. Moreover, participating couples found intimacy and relational attunement through shared reflections.

    Conclusion

    Based on the findings, it appears that the participants in this study felt that using excerpts from dementia-related literature to deliberate on ethical issues was feasible and acceptable. Deliberating on ethical issues with peers and family caregivers offers valuable social support and opportunities for strengthening relationships.

    Implications for patient care

    This study makes an important contribution by providing valuable insights into how ethical issues related to living with dementia can be addressed using related literature and suggests how the intervention can be integrated into existing care initiatives for home-dwelling people with dementia and their families.

    Reporting method

    We have adhered to relevant EQUATOR guidelines with the COREQ reporting method.

    Patient or public contribution

    A healthcare professional working as a so-called dementia coordinator (a title used in the Danish context) was involved in the conduct of this study by being responsible for the recruitment of home-dwelling people with dementia and their family members. Moreover, she had joint responsibility for facilitating the intervention along with the first author.

    Beliefs and practices of the nursing team related to pressure injury preventive measures: A analysis of social representations

    Abstract

    Aims and Objectives

    To analyse the process of elaborating social representations about pressure injury preventive measures by the nursing team (nurses and nurse technicians) and how this process relates to preventive practices for hospitalized patients.

    Design

    Qualitative study, with the application of the theory of social representations in its procedural methodological approach.

    Methods

    The study was carried out in an inpatient clinic of a public hospital in the state of Rondônia, Brazil. Totally, 28 nursing professionals in the medical clinic sectors who had worked directly with patient care for more than 6 months participated. The data were collected between July and September 2021 via in-depth interviews with the application of a semi-structured instrument. Analysis was carried out with the help of ALCESTE software, which performed a lexicographic analysis, and also via thematic analysis. The COREQ guided the presentation of the research report.

    Results

    The social representations were developed based on the professionals' symbolic beliefs about the visibility/invisibility of the results of applying preventive care. These symbolic constructions mobilized positive and negative feelings among the nursing team, which guided the classification of prevention practices as being of greater or lesser priority among other care activities. There were favourable attitudes among professionals, which included applying prevention measures in their daily routines, and unfavourable attitudes of non-adherence to the institution's protocol for preventing pressure injuries.

    Conclusions

    The nursing team's perception of pressure injury prevention is influenced by symbolic, affective, values, and social dimensions. Non-adherence behaviours are attributed to the belief in the invisibility of prevention outcomes, resulting in a reluctance to implement preventive measures.

    Relevance to Clinical Practice

    Understanding the subjective logic that explains the thinking and actions of the nursing team suggests the need to incorporate discussions on beliefs, values, sentiments, and attitudes of nursing professionals into educational programs on pressure injury prevention.

    Patient or Public Contribution

    No public contribution.

    Mapping health promotion practices across key sectors and its intersectoral approach at the local level: Study protocol

    Abstract

    Aims

    This study outlines a protocol aimed at identifying and mapping health promotion practices in need of development from the perspectives of key sectors responsible for it at the local level and from an intersectoral perspective across four Spanish regions.

    Design

    A complementary multi-method study combining survey methods and qualitative interviews will be adopted.

    Methods

    Purposive snowball sampling will be employed to select potentially rich informants from city councils, primary care centres, primary and secondary schools, and public health and civil society organizations in 12 municipalities sensitive to local health. Data on the degree of execution of health promotion activities, the level of intersectorality in their implementation, and their origins will be collected using PromoACTIVA questionnaires, an intersectoral typology model and an interview protocol. A parallel mixed analysis encompassing descriptive statistics and a ‘framework analysis’ will be performed.

    Discussion

    This study is expected to yield thorough and reliable insights into health promotion practices and omissions at the local level by focusing on key stakeholders, both individually and collaboratively. This information can enhance health promotion planning and improve its effectiveness, efficiency and contextual relevance. The development and testing of a methodology for the integration and interpretation of these data will ensure sustainable capacity building.

    Impact

    Managers and practitioners interested in health promotion planning in the researched settings can benefit from a comprehensive map of the current state of their practices and insights into the starting points of collaboration. In addition, planners from other local settings will gain access to tools and methodologies to replicate and expand these maps to their own contexts.

    Stakeholder Engagement

    Engaging key stakeholders with experience working in or with primary care centres, public health organizations, primary and secondary schools, civil society organizations, and city councils was vital to ensure the study's relevance and feasibility.

    Topical oxygen therapy and singlet oxygen in wound healing: A scoping review

    Abstract

    The aim of this scoping review was to provide an overview of current research into topical oxygen therapies including the under-researched singlet oxygen for wound healing. A scoping review was undertaken using five databases. After duplicates and ineligible studies were excluded, 49 studies were included for a narrative review. Out of the included 49 studies, 45 (91.8%) were published in the past 10 years (2013–2023) with 32 (65.3%) published in the past 5 years (2018–2023). Eight of the studies were systematic reviews and/or meta-analysis and 18 were RCTs. The search identified zero human RCTs on singlet oxygen, but one human cohort study and five studies in animals. There is evidence that topical oxygen therapy may be useful for the treatment of chronic wounds, mainly diabetic foot ulcers. Singlet oxygen has shown potential, but would need further confirmation in controlled human trials, including more research to understand the bio-properties.

    Out‐of‐pocket expenditure among patients with diabetic foot ulcer in a tertiary care hospital of south India: A cross‐sectional study

    Abstract

    Diabetic foot ulcer is a debilitating complication of long-standing diabetes mellitus. Patients lose their earning potential, face repeated hospitalizations, and are forced to bear heavy treatment costs. This places an enormous financial burden on the patients and their families. This study seeks to ascertain the out-of-pocket expenditure among these patients and correlate it with their risk factor profile. In this hospital-based cross-sectional study, a total of 154 patients with diabetic foot ulcers or amputations have been studied with an elaborate patient questionnaire and relevant clinical examinations. The costs incurred and the risk factors of the patients were analyzed for statistical association. The median total annual out-of-pocket expenditure for the management of diabetic foot ulcers among the study participants was found to be ₹29 775 (₹9650–₹81 120) ($378.14 [$122.56–$1030.22]). Out of the total expenditure, 58.49% went towards direct medical costs, 5.64% towards direct non-medical costs, and 35.88% for indirect costs. Medications, ulcer dressing and periodic debridement have accounted for 79.26% of direct medical costs. Transportation (61.37%) and patient's loss of income (89.45%) account for the major costs under the direct non-medical and indirect cost categories, respectively. A high ulcer grade and area, long ulcer duration, and past history of ulcers have higher expenditure. Patients seeking treatment from private establishments and those engaged in professional/skilled occupations have higher expenses. Adequate dressing of foot ulcers and proper footwear are associated with lower treatment expenditure. 68.8% of the participants have faced catastrophic expenditure due to treatment costs of diabetic foot ulcers. Adequate glycaemic control and proper foot care are necessary. Patients must seek medical care at the earliest in case of foot ulceration. Clinicians must provide proper wound care, institute effective antibiotics, and manage the complications. Government and insurance schemes are required to alleviate the patients' financial burden.

    Developing and testing a reflection method for implementation of the informal care guideline in community nursing: Design‐based research

    Abstract

    Aim

    To develop a reflection method for community nurses and certified nursing assistants to support the implementation of the Dutch Informal Care guideline in daily care.

    Design

    Design-based research.

    Methods

    A design group and four test groups of community nurses and nursing assistants were formed to develop a reflection method that aligns with the needs and preferences of its end-users. The design and test group meetings were video recorded. The video data were iteratively discussed and analysed thematically to adapt and refine the method and to identify its key features.

    Results

    A final reflection method was developed. Five main themes were identified from the analysis: the group, reflective triggers, knowledge about the guidelines, the coach and preconditions. The themes are linked to nine key features representing the building blocks of the reflection method. The key features are group size, participants with different (educational) backgrounds, pairs of participants, expressing thoughts, video feedback, reflection game, making the connection with the guideline, coaching as a process facilitator and meeting organizational and contextual conditions for implementation.

    Conclusion

    An evidence- and practice-based reflection method for community nurses and certified nursing assistants is developed to support the implementation. By involving community nurses and certified nursing assistants, the method closely matches their needs and preferences. Critical elements of the reflection method are a game element, video feedback and working in pairs in a group of participants from different (educational) backgrounds. Guidance is needed to make the transfer from theory to practice.

    Impact

    A reflection method for community nurses and certified nursing assistants was developed to enhance care work according to guideline recommendations, aiming to improve the care provided by informal caregivers.

    Report Method

    The COREQ guideline was used.

    Patient or Public Contribution

    This reflection method was developed in close collaboration with all stakeholders during the entire study.

    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.

    Prevalence and impact of sarcopenia in individuals with heart failure with reduced ejection fraction (the SARC-HF study): A prospective observational study protocol

    by Pablo Marino Corrêa Nascimento, Luiz Fernando Rodrigues Junior, Mauro Felippe Felix Mediano, Valéria Gonçalves da Silva, Bernardo Rangel Tura, Fabio César Sousa Nogueira, Gilberto Domont, Adriana Bastos Carvalho, Antônio Carlos Campos de Carvalho, Taís Hanae Kasai-Brunswick, Claudio Tinoco Mesquita, Humberto Villacorta Junior, Helena Cramer Veiga Rey

    Sarcopenia, a clinical syndrome primarily associated with reduced muscle mass in the elderly, has a negative impact on quality of life and survival. It can occur secondarily to other diseases such as heart failure (HF), a complex clinical syndrome with high morbidity and mortality. The simultaneous occurrence of these two conditions can worsen the prognosis of their carriers, especially in the most severe cases of HF, as in patients with reduced left ventricular ejection fraction (LVEF). However, due to the heterogeneous diagnostic criteria for sarcopenia, estimates of its prevalence present a wide variation, leading to new criteria having been recently proposed for its diagnosis, emphasizing muscle strength and function rather than skeletal muscle mass. The primary objective of this study is to evaluate the prevalence of sarcopenia and/or dynapenia in individuals with HF with reduced LVEF according to the most recent criteria, and compare the gene and protein expression of those patients with and without sarcopenia. The secondary objectives are to evaluate the association of sarcopenia and/or dynapenia with the risk of clinical events and death, quality of life, cardiorespiratory capacity, ventilatory efficiency, and respiratory muscle strength. The participants will answer questionnaires to evaluate sarcopenia and quality of life, and will undergo the following tests: handgrip strength, gait speed, dual-energy X-ray absorptiometry, respiratory muscle strength, cardiopulmonary exercise, as well as genomic and proteomic analysis, and dosage of N-terminal pro-B-type natriuretic peptide and growth differentiation factor-15. An association between sarcopenia and/or dynapenia with unfavorable clinical evolution is expected to be found, in addition to reduced quality of life, cardiorespiratory capacity, ventilatory efficiency, and respiratory muscle strength.

    Anxiety disorders among youth with substance use and associated factors in Northwest Ethiopia: A community-based study

    by Mamaru Melkam, Demeke Demilew, Tilahun Kassew, Biruk Fanta, Sewbesew Yitayih, Kassahun Alemu, Yassin Muhammed, Berhanie Getnet, Eden Abetu, Gebrekidan Ewnetu Tarekeg, Mohammed Oumer, Goshu Nenko

    Introduction

    Anxiety disorder is an unpleasant emotional feeling with symptoms related to psychological and autonomic symptoms such as headache, perspiration, palpitations, dizziness, and stomach discomfort. The use of substances become a worldwide problem among youth which brings situation that leads to serious social and health-related problems. Anxiety disorders with substance use have a huge impact on their high prevalence, therapeutic issues, and poor prognosis on clinical effects. Although the prevalence of anxiety disorders is significant among young people who use substances, limited studies were conducted. Therefore, this study revealed the burden of anxiety disorders among youth with substance use and associated factors in Ethiopia.

    Method

    A community-based multi-stage with a simple random sampling technique was conducted. A total of 372 substance users study participants were recruited for this study. Alcohol, Smoking, and Substance Involvement Screening Tests, Depression Anxiety Stress Scales, and other tools were used to assess anxiety disorders with substance use and associated factors. Data were entered into Epi-data version 4.6, and exported to SPSS version 20 for further analysis. Bi-variables logistic regression analysis was employed to identify variables with a p-value of Results

    From a total of 372 respondents the overall prevalence of anxiety disorders with substance use was 48.1%. Male sex [AOR = 1.99; 95% CI: (1.01–3.93)], low educational status of the father [AOR = 6.38 95%CI: (1.50–7.08)], and the presence of stress [AOR = 2.48; 95% CI: 2.48(2.43–4.40)] were significantly associated factors with anxiety disorders with substances use.

    Conclusions and recommendations

    The prevalence of anxiety disorders with substance use was 48.1% therefore; it is recommended that the zonal administration give collaborative work with the health bureau and facilitate awareness creation about the impact of substance abuse. Clinicians are recommended to mitigate anxiety disorders with substance use to get a good prognosis for clients with controlling their stress.

    Retinoid orphan receptor gamma t (rorγt) promotes inflammatory eosinophilia but is dispensable for innate immune-mediated colitis

    by Alvaro Torres-Huerta, Katelyn Ruley-Haase, Theodore Reed, Antonia Boger-May, Derek Rubadeux, Lauren Mayer, Arpitha Mysore Rajashekara, Morgan Hiller, Madeleine Frech, Connor Roncagli, Cameron Pedersen, Mary Catherine Camacho, Lauren Hollmer, Lauren English, Grace Kane, David L. Boone

    Inflammatory bowel diseases (IBD) result from uncontrolled inflammation in the intestinal mucosa leading to damage and loss of function. Both innate and adaptive immunity contribute to the inflammation of IBD and innate and adaptive immune cells reciprocally activate each other in a forward feedback loop. In order to better understand innate immune contributions to IBD, we developed a model of spontaneous 100% penetrant, early onset colitis that occurs in the absence of adaptive immunity by crossing villin-TNFAIP3 mice to RAG1-/- mice (TRAG mice). This model is driven by microbes and features increased levels of innate lymphoid cells in the intestinal mucosa. To investigate the role of type 3 innate lymphoid cells (ILC3) in the innate colitis of TRAG mice, we crossed them to retinoid orphan receptor gamma t deficient (Rorγt-/-) mice. Rorγt-/- x TRAG mice exhibited markedly reduced eosinophilia in the colonic mucosa, but colitis persisted in these mice. Colitis in Rorγt-/- x TRAG mice was characterized by increased infiltration of the intestinal mucosa by neutrophils, inflammatory monocytes, macrophages and other innate cells. RNA and cellular profiles of Rorγt-/- x TRAG mice were consistent with a lack of ILC3 and ILC3 derived cytokines, reduced antimicrobial factors, increased activation oof epithelial repair processes and reduced activation of epithelial cell STAT3. The colitis in Rorγt-/- x TRAG mice was ameliorated by antibiotic treatment indicating that microbes contribute to the ILC3-independent colitis of these mice. Together, these gene expression and cell signaling signatures reflect the double-edged sword of ILC3 in the intestine, inducing both proinflammatory and antimicrobial protective responses. Thus, Rorγt promotes eosinophilia but Rorγt and Rorγt-dependent ILC3 are dispensable for the innate colitis in TRAG mice.

    SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres

    Por: Del Fiol · G. · Orleans · B. · Kuzmenko · T. V. · Chipman · J. · Greene · T. · Martinez · A. · Wirth · J. · Meads · R. · Kaphingst · K. K. · Gibson · B. · Kawamoto · K. · King · A. J. · Siaperas · T. · Hughes · S. · Pruhs · A. · Pariera Dinkins · C. · Lam · C. Y. · Pierce · J. H. · Benson
    Introduction

    SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).

    Methods and analysis

    The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2x2x2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2x2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.

    Ethics and dissemination

    The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.

    Trial registration number

    ClinicalTrials.gov: NCT05533918 and NCT05533359.

    Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol

    Por: Grant · S. J. · Kay · S. · Lacey · J. · Kumar · S. · Kerin-Ayres · K. · Stehn · J. · Gonzalez · M. · Templeton · S. · Heller · G. · Cockburn · J. · Wahlroos · S. · Malalasekera · A. · Mak · C. · Graham · S.
    Introduction

    Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed ‘prehabilitation’) may mitigate these side effects and improve quality of life.

    During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that ‘packaged’ care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme.

    Methods and analysis

    This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20–30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them.

    Ethics and dissemination

    The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences.

    Trial registration number

    ACTRN12622000584730.

    IMproving psYchosocial adjustment to Traumatic Brain Injury from acute to chronic injury through development and evaluation of the myTBI online psychoeducation platform: protocol for a mixed-methods study

    Por: Troeung · L. · Sarunga Raja · T. L. · Mann · G. · Wagland · J. · MacLeod · C. · Martini · A.
    Introduction

    This protocol describes the myTBI study which aims to: (1) develop an online psychoeducation platform for people with traumatic brain injury (TBI), their family members/caregivers, and healthcare staff to improve psychosocial adjustment to TBI across different phases of injury (acute, postacute, and chronic), and (2) undertake an evaluation of efficacy, acceptability, and feasibility.

    Methods and analysis

    A three-stage mixed-methods research design will be used. The study will be undertaken across four postacute community-based neurorehabilitation and disability support services in Western Australia. Stage 1 (interviews and surveys) will use consumer-driven qualitative methodology to: (1) understand the recovery experiences and psychosocial challenges of people with TBI over key stages (acute, postacute, and chronic), and (2) identify required areas of psychosocial support to inform the psychoeducation platform development. Stage 2 (development) will use a Delphi expert consensus method to: (1) determine the final psychoeducation modules, and (2) perform acceptance testing of the myTBI platform. Finally, stage 3 (evaluation) will be a randomised stepped-wedge trial to evaluate efficacy, acceptability, and feasibility. Outcomes will be measured at baseline, postintervention, follow-up, and at final discharge from services. Change in outcomes will be analysed using multilevel mixed-effects modelling. Follow-up surveys will be conducted to evaluate acceptability and feasibility.

    Ethics and dissemination

    Ethics approval was granted by North Metropolitan Health Service Mental Health Research Ethics and Governance Office (RGS0000005877). Study findings will be relevant to clinicians, researchers, and organisations who are seeking a cost-effective solution to deliver ongoing psychoeducation and support to individuals with TBI across the recovery journey.

    Trial registration number

    ACTRN12623000990628.

    Can glycated haemoglobin (HbA1c) be used as a predictor of left ventricular diastolic dysfunction in non-hypertensive patients with newly diagnosed type 2 diabetes mellitus: a cross-sectional study at a tertiary care centre in Eastern India

    Por: Porel · R. · Shyama · S. · Ahmad · S. · Kumar · N. · Ahmad · S. · Biswas · R. · Ojha · V. S.
    Objectives

    This study was conducted to establish the association between glycated haemoglobin (HbA1c) and left ventricular diastolic dysfunction (LVDD) in non-hypertensive patients with newly diagnosed type 2 diabetes mellitus (DM) and determine the cut-off value of HbA1c for detecting LVDD.

    Design

    Cross-sectional study.

    Setting

    This study was conducted in General Medicine Department in collaboration with the Cardiology Department at All India Institute of Medical Sciences, Patna.

    Participants

    The study population comprised patients with newly diagnosed type 2 DM within the past 3 months, aged between 18 years and 80 years, who were not hypertensive and without any systemic diseases and who presented to the General Medicine Department.

    Primary and secondary outcome measures

    The presence of LVDD was the primary outcome measure.

    Results

    Among the total of 60 participants, it was observed that age (adjusted odds ratio (AOR): 1.169, 95% CI: 1.066 to 1.283) and HbA1c (AOR: 2.625, 95% CI: 1.264 to 5.450) were found to be independent predictors for the presence of LVDD. Receiver operating characteristic analysis identified a cut-off value of HbA1c at 9.5% (80 mmol/mol) for detecting LVDD, with a specificity of 96.43%, a sensitivity of 37.5% and a positive predictive value (PPV) of 91.62%.

    Conclusions

    This study demonstrated that age and HbA1c levels are independent predictors of LVDD in patients with newly diagnosed type 2 DM without hypertension. A cut-off value of 9.5% for HbA1c was identified with a high specificity and PPV for predicting LVDD in patients with newly diagnosed type 2 diabetes. This underscores the importance of conducting echocardiography in patients with newly diagnosed asymptomatic type 2 diabetes with HbA1c 9.5% or more to assess LVDD, allowing for prompt interventions if necessary and to decelerate the progression towards heart failure.

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