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Association between the nurse work environment and patient experience in Chilean hospitals: A multi‐hospital cross‐sectional study

Abstract

Introduction

International evidence shows that nurses' work environments affect patient outcomes, including their care experiences. In Chile, several factors negatively affect the work environment, but they have not been addressed in prior research. The aim of this study was to measure the quality of the nurse work environment in Chilean hospitals and its association with patient experience.

Design

A cross-sectional study of 40 adult general high-complexity hospitals across Chile.

Methods

Participants included bedside nurses (n = 1632) and patients (n = 2017) in medical or surgical wards, who responded to a survey. The work environment was measured through the Practice Environment Scale of the Nursing Work Index. Hospitals were categorized as having a good or poor work environment. A set of patient experience outcomes were measured through the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. Adjusted logistic regression models were used to test associations between the environment and patient experiences.

Results

For all outcomes, the percentage of patients satisfied was higher in hospitals with good as compared to poor work environments. In good environment hospitals patients had significantly higher odds of being satisfied with communication with nurses (OR 1.46, 95% CI: 1.10–1.94, p = 0.010), with pain control (OR 1.52, 95% CI: 1.14–2.02, p = 0.004), and with nurses' timely responses in helping them to go to the bathroom (OR 2.17, 95% CI: 1.49–3.16, p < 0.0001).

Conclusions

Hospitals with good environments outperform hospitals with poor environments in most patient care experience indicators. Efforts to improve nurses' work environment hold promise for improving patient experiences in Chilean hospitals.

Clinical Relevance

Hospital administrators and nurse managers should value, especially in the context of financial constraints and understaffing, the implementation of strategies to improve the quality of nurses´ work environments so that they can provide patients with a better care experience.

Nurses' self‐care strategies: A mapping review

Abstract

Objectives

Nurses have long received recommendations to employ self-care behaviors to ensure their ability to remain in the profession; however, nurses are rarely asked what self-care behaviors are beneficial. This literature review aimed to map studies on nurses' self-care strategies to provide an understanding of how these strategies are addressed in the literature and to identify gaps in need of additional exploration.

Method

Searches were conducted in accordance with published mapping review methodologies across MEDLINE, Embase, CINAHL, Scopus, PsycINFO, Web of Science, and identified influential nursing journals. Included studies were from the United States, peer-reviewed, and described self-care strategies related to nurses or the nursing profession.

Results

Thirty-five articles were identified for inclusion and were evaluated based on agreed-upon criteria to define how the concept of self-care was studied and applied to nurses. Three main categories were identified in this review: self-care and stress; self-care and burnout; and self-care and leadership, workplace factors, and physical activity.

Linking Evidence to Action

This mapping review revealed an abundance of literature related to self-care recommendations for nurses; however, there remains a dearth of studies investigating how nurses utilize self-care behaviors independently to improve their own professional well-being. Recommendations for next steps in research in this area are included.

Chinese family care partners of older adults in Canada have grit: A qualitative study

Abstract

Aim

To explain the process taken by Chinese family care partners of older adults in the Greater Toronto Area, Canada, to access health and social services in their communities. The research question was: What mechanisms and structures impact the agency of Chinese family care partners of older adults, in the process of assisting them to access health and social services?

Design

This qualitative study was informed by critical realism.

Methods

Chinese family care partners of older adults in the Greater Toronto Area, Canada, were interviewed from August 2020 to June 2021. Transcripts underwent thematic analysis.

Findings

Twenty-eight Chinese family care partners expressed a firm commitment to maintain caregiving conditions and to judiciously access health and social services. Their commitment was made up of three parts: (a) legislative and cultural norms of family, work, and society; (b) their perseverance to fill gaps with limited social and financial resources; (c) the quality of their relationship to, and illness trajectory of the older adults. The social structures created tension in how Chinese family care partners made decisions, negotiated resources, and ultimately monitored and coordinated timely access with older adults.

Conclusion

Participants' commitment and perseverance were conceptualized as “grit,” central to their agency to conform to legislative and cultural norms. Moreover, findings support grit's power to motivate and sustain family caregiving, in order for older adults to age in place as long as possible with finite resources.

Implications for the profession

This study highlights the importance of cultural awareness education for nurses, enabling continuity of care at a systems level and for a more resilient healthcare system.

Impact

Family care partners' grit may be crucial for nurses to harness when together, they face limited access to culturally appropriate health and social services in a system grounded in values of equity and inclusion, as in Canada.

Reporting method

When writing this manuscript, we adhered to relevant EQUATOR guidelines of the Consolidated Criteria for Reporting Qualitative Research (COREQ).

Patient or public involvement and engagement

No patient or public involvement.

Protocol for validating an algorithm to identify neurocognitive disorders in Canadian Longitudinal Study on Aging participants: an observational study

Por: Mayhew · A. J. · Hogan · D. · Raina · P. · Wolfson · C. · Costa · A. P. · Jones · A. · Kirkland · S. · O'Connell · M. · Taler · V. · Smith · E. E. · Liu-Ambrose · T. · Ma · J. · Thompson · M. · Wu · C. · Chertkow · H. · Griffith · L. E. · On behalf of the CLSA Memory Study Working Grou
Introduction

In population-based research, disease ascertainment algorithms can be as accurate as, and less costly than, performing supplementary clinical examinations on selected participants to confirm a diagnosis of a neurocognitive disorder (NCD), but they require cohort-specific validation. To optimise the use of the Canadian Longitudinal Study on Aging (CLSA) to understand the epidemiology and burden of NCDs, the CLSA Memory Study will validate an NCD ascertainment algorithm to identify CLSA participants with these disorders using routinely acquired study data.

Methods and analysis

Up to 600 CLSA participants with equal numbers of those likely to have no NCD, mild NCD or major NCD based on prior self-reported physician diagnosis of a memory problem or dementia, medication consumption (ie, cholinesterase inhibitors, memantine) and/or self-reported function will be recruited during the follow-up 3 CLSA evaluations (started August 2021). Participants will undergo an assessment by a study clinician who will also review an informant interview and make a preliminary determination of the presence or absence of an NCD. The clinical assessment and available CLSA data will be reviewed by a Central Review Panel who will make a final categorisation of participants as having (1) no NCD, (2) mild NCD or, (3) major NCD (according to fifth version of the Diagnostic and Statistical Manual of Mental Disorders criteria). These will be used as our gold standard diagnosis to determine if the NCD ascertainment algorithm accurately identifies CLSA participants with an NCD. Weighted Kappa statistics will be the primary measure of agreement. Sensitivity, specificity, the C-statistic and the phi coefficient will also be estimated.

Ethics and dissemination

Ethics approval has been received from the institutional research ethics boards for each CLSA Data Collection Site (Université de Sherbrooke, Hamilton Integrated Research Ethics Board, Dalhousie University, Nova Scotia Health Research Ethics Board, University of Manitoba, McGill University, McGill University Health Centre Research Institute, Memorial University of Newfoundland, University of Victoria, Élisabeth Bruyère Research Institute of Ottawa, University of British Columbia, Island Health (Formerly the Vancouver Island Health Authority, Simon Fraser University, Calgary Conjoint Health Research Ethics Board).

The results of this work will be disseminated to public health professionals, researchers, health professionals, administrators and policy-makers through journal publications, conference presentations, publicly available reports and presentations to stakeholder groups.

Behavioural outcomes of children born with intrauterine growth restriction: protocol for a systematic review and meta-analysis

Por: Yakoub · N. · Reinelt · T. · Natalucci · G.
Introduction

Intrauterine growth restriction (IUGR) is a pregnancy condition, which is associated with poor perinatal outcomes and long-term neurodevelopmental impairment. Several studies also investigated the impact of IUGR on child behaviour (eg, internalising and externalising behaviour, social competencies). However, so far, no systematic review or meta-analysis has been conducted that summarises these effects while considering relevant third variables such as type of IUGR diagnosis and control group, or concurrent cognitive abilities. The objective of this study is to summarise the current evidence regarding the relationship between IUGR and behavioural outcomes from early childhood to young adulthood. Additionally, to explore how third variables such as type of control group, or cognitive abilities, relate to this association.

Methods

Search strategy: The following electronic databases will be searched—Web of Science, Medline Ovid, PsycInfo, Cochrane Library, Scopus and Embase. Inclusion criteria: observational (eg, cohort studies and case–control studies) and intervention studies (if standard care is used and norm values are reported for the control group) will be included if they quantitatively compare children with and without IUGR from the age of 2 to 18 years. The main outcomes are internalising and externalising behaviour, and social competencies.

Ethics and dissemination

No ethics approval was necessary for this protocol. Dissemination of findings will be done by publishing the results in peer-reviewed journals. The results of this systematic review will provide guidance for practice and counselling for clinicians and therapists facing patients affected by IUGR and their families.

PROSPERO registration number

CRD42022347467.

Cohort profile: recruitment and retention in a prospective cohort of Canadian healthcare workers during the COVID-19 pandemic

Por: Cherry · N. · Adisesh · A. · Burstyn · I. · Durand-Moreau · Q. · Galarneau · J.-M. · Labreche · F. · Ruzycki · S. M. · Zadunayski · T.
Purpose

Healthcare workers were recruited early in 2020 to chart effects on their health as the COVID-19 pandemic evolved. The aim was to identify modifiable workplace risk factors for infection and mental ill health.

Participants

Participants were recruited from four Canadian provinces, physicians (medical doctors, MDs) in Alberta, British Columbia, Ontario and Quebec, registered nurses (RNs), licensed practical nurses (LPNs) and healthcare aides (HCAs) in Alberta and personal support workers (PSWs) in Ontario. Volunteers gave blood for serology testing before and after vaccination. Cases with COVID-19 were matched with up to four referents in a nested case-referent study.

Findings to date

Overall, 4964/5130 (97%) of those recruited joined the longitudinal cohort: 1442 MDs, 3136 RNs, 71 LPNs, 235 PSWs, 80 HCAs. Overall, 3812 (77%) were from Alberta. Prepandemic risk factors for mental ill health and respiratory illness differed markedly by occupation. Participants completed questionnaires at recruitment, fall 2020, spring 2021, spring 2022. By 2022, 4837 remained in the cohort (127 had retired, moved away or died), for a response rate of 89% (4299/4837). 4567/4964 (92%) received at least one vaccine shot: 2752/4567 (60%) gave postvaccine blood samples. Ease of accessing blood collection sites was a strong determinant of participation. Among 533 cases and 1697 referents recruited to the nested case-referent study, risk of infection at work decreased with widespread vaccination.

Future plans

Serology results (concentration of IgG) together with demographic data will be entered into the publicly accessible database compiled by the Canadian Immunology Task Force. Linkage with provincial administrative health databases will permit case validation, investigation of longer-term sequelae of infection and comparison with community controls. Analysis of the existing dataset will concentrate on effects on IgG of medical condition, medications and stage of pregnancy, and the role of occupational exposures and supports on mental health during the pandemic.

Association between social isolation and loneliness with COVID-19 vaccine uptake in Japan: a nationwide cross-sectional internet survey

Por: Ukai · T. · Tabuchi · T.
Objectives

We examined the association between social isolation and loneliness, increasingly recognised but neglected social determinants of health, with being unvaccinated against COVID-19.

Design

This was a cross-sectional study.

Setting and participants

A representative cohort of 22 756 individuals (aged 15–81 years) from the general Japanese population who responded to both the Japan COVID-19 and Society Internet Survey 2021 and Japan Society and New Tobacco Internet Survey 2022.

Primary and secondary outcome measures

We calculated the ORs of remaining unvaccinated against COVID-19 in 2022, attributable to social isolation as assessed by the Lubben Social Network Scale, or loneliness as evaluated by the University of California, Los Angeles Loneliness Scale version 3. Reasons for abstaining from vaccination were solicited from the unvaccinated respondents. A multivariable logistic regression model was conducted with adjustments for demographic variables. Propensity score-matched comparisons were conducted as part of the sensitivity analysis.

Results

Individuals with social isolation were more likely to be unvaccinated (OR 1.48, 95% CI 1.37 to 1.60), while individuals with loneliness were not (OR 0.96, 95% CI 0.88 to 1.05). Socially isolated individuals were significantly less likely to receive information from people who had been vaccinated (11% vs 15%) and less likely not to trust the vaccine approval process (19% vs 27%) compared with those who were not socially isolated.

Conclusions

Despite not harbouring negative perceptions of the vaccine, socially isolated individuals exhibited lower rates of COVID-19 vaccination. Socially isolated individuals are important targets to reach to increase the number of vaccinated individuals.

Supporting adolescents participation in muscle-strengthening physical activity: protocol for the 'Resistance Training for Teens (RT4T) hybrid type III implementation-effectiveness trial

Por: Kelly · H. T. · Smith · J. J. · Verdonschot · A. · Kennedy · S. G. · Scott · J. J. · McKay · H. · Nathan · N. · Sutherland · R. · Morgan · P. J. · Salmon · J. · Penney · D. · Boyer · J. · Lloyd · R. S. · Oldmeadow · C. · Reeves · P. · Pursey · K. · Hua · M. · Longmore · S. · Norman · J. · Vo
Introduction

In Australia, only 22% of male and 8% of female adolescents meet the muscle-strengthening physical activity guidelines, and few school-based interventions support participation in resistance training (RT). After promising findings from our effectiveness trial, we conducted a state-wide dissemination of the ‘Resistance Training for Teens’ (RT4T) intervention from 2015 to 2020. Despite high estimated reach, we found considerable variability in programme delivery and teachers reported numerous barriers to implementation. Supporting schools when they first adopt evidence-based programmes may strengthen programme fidelity, sustainability, and by extension, programme impact. However, the most effective implementation support model for RT4T is unclear.

Objective

To compare the effects of three implementation support models on the reach (primary outcome), dose delivered, fidelity, sustainability, impact and cost of RT4T.

Methods and analysis

We will conduct a hybrid type III implementation–effectiveness trial involving grade 9 and 10 (aged 14–16 years) students from 90 secondary schools in New South Wales (NSW), Australia. Schools will be recruited across one cohort in 2023, stratified by school type, socioeconomic status and location, and randomised in a 1:1:1 ratio to receive one of the following levels of implementation support: (1) ‘low’ (training and resources), (2) ‘moderate’ (training and resources+external support) or ‘high’ (training and resources+external support+equipment). Training includes a teacher workshop related to RT4T programme content (theory and practical sessions) and the related resources. Additional support will be provided by trained project officers from five local health districts. Equipment will consist of a pack of semiportable RT equipment (ie, weighted bars, dumbbells, resistance bands and inverted pull up bar stands) valued at ~$A1000 per school. Study outcomes will be assessed at baseline (T0), 6 months (T1) and 18 months (T2). A range of quantitative (teacher logs, observations and teacher surveys) and qualitative (semistructured interviews with teachers) methods will be used to assess primary (reach) and secondary outcomes (dose delivered, fidelity, sustainability, impact and cost of RT4T). Quantitative analyses will use logistic mixed models for dichotomous outcomes, and ordinal or linear mixed effects regression models for continuous outcomes, with alpha levels set at p

Ethics and dissemination

Ethics approval has been obtained from the University of Newcastle (H-2021-0418), the NSW Department of Education (SERAP:2022215), Hunter New England Human Research Ethics Committee (2023/ETH00052) and the Catholic Schools Office. The design, conduct and reporting will adhere to the Consolidated Standards of Reporting Trials statement, the Standards for Reporting Implementation Studies statement and the Template for Intervention Description and Replication checklist. Findings will be published in open access peer-reviewed journals, key stakeholders will be provided with a detailed report. We will support ongoing dissemination of RT4T in Australian schools via professional learning for teachers.

Trial registration number

ACTRN12622000861752.

Magnitude of occupational exposure to sharp injuries among nurses working in South Gondar zone public hospitals, Northcentral Ethiopia: institution-based cross-sectional study

Por: Aytenew · T. M. · Kassie · Y. T. · Kebede · S. D.
Objective

This study aimed to determine the magnitude of occupational exposure to sharp injuries and identify its associated factors among nurses.

Design

Institution-based cross-sectional study design was conducted from 1 to 30 November 2022.

Analysis

The collected data were entered into EpiData V.4.2; then, exported to Stata V.14 for analysis. Variables with a p value of

Setting

The study was conducted in South Gondar zone public hospitals.

Participants

Nurses working in South Gondar zone public hospitals.

Results

Of the total respondents, 213 (56.65%) were between the ages of 25 and 34 with the mean±SD of age 30.22±6.63 years. Similarly, 202 (53.72%) of the respondents were women. This study finding showed that the magnitude of occupational exposure to sharp injuries among nurses was 52.39% (95% CI: 47.92% to 56.37%). Moreover, this study finding showed that year of service >10 years (adjusted OR (AOR)=2.35, 95% CI: 1.21 to 4.57), lack of infection prevention training (AOR=1.85, 95% CI: 1.09 to 3.45), job-related stress (AOR=2.24, 95% CI: 1.27 to 3.89) and presence of contaminated sharps at the workplace (AOR=2.76, 95% CI: 1.67 to 4.72) were significantly associated with occupational exposure to sharp injuries among nurses.

Conclusions

Generally, this study finding reported that the magnitude of occupational exposure to sharp injuries among nurses was high. This study finding also showed that years of service >10 years, lack of infection prevention training, job-related stress and the presence of contaminated sharps at the workplace were independent predictors of occupational exposure to sharp injuries among nurses. Hence, all the concerned bodies should strengthen regular provision of infection prevention training to nurses at all levels. Nurses should practice proper use of safety box more than ever in order to avoid the presence of contaminated needles and other sharp materials at the workplace.

Study protocol for a longitudinal observational study of disparities in sleep and cognition in older adults: the DISCO study

Por: Knutson · K. L. · Pershing · M. L. · Abbott · S. · Alexandria · S. J. · Chiluka · S. · Chirinos · D. · Giachello · A. · Gupta · N. · Harrington · K. · Rittner · S. S. · Sorond · F. · Wong · M. · Vu · T.-H. T. · Zee · P. C. · Carnethon · M. R.
Introduction

Cognitive dysfunction, a leading cause of mortality and morbidity in the USA and globally, has been shown to disproportionately affect the socioeconomically disadvantaged and those who identify as black or Hispanic/Latinx. Poor sleep is strongly associated with the development of vascular and metabolic diseases, which correlate with cognitive dysfunction. Therefore, sleep may contribute to observed disparities in cognitive disorders. The Epidemiologic Study of Disparities in Sleep and Cognition in Older Adults (DISCO) is a longitudinal, observational cohort study that focuses on gathering data to better understand racial/ethnic sleep disparities and illuminate the relationship among sleep, race and ethnicity and changes in cognitive function. This investigation may help inform targeted interventions to minimise disparities in cognitive health among ageing adults.

Methods and analysis

The DISCO study will examine up to 495 individuals aged 55 and older at two time points over 24 months. An equal number of black, white and Hispanic/Latinx individuals will be recruited using methods aimed for adults traditionally under-represented in research. Study procedures at each time point will include cognitive tests, gait speed measurement, wrist actigraphy, a type 2 home polysomnography and a clinical examination. Participants will also complete self-identified assessments and questionnaires on cognitive ability, sleep, medication use, quality of life, sociodemographic characteristics, diet, substance use, and psychological and social health.

Ethics and dissemination

This study was approved by the Northwestern University Feinberg School of Medicine Institutional Review Board. Deidentified datasets will be shared via the BioLINCC repository following the completion of the project. Biospecimen samples from the study that are not being analysed can be made available to qualified investigators on review and approval by study investigators. Requests that do not lead to participant burden or that conflict with the primary aims of the study will be reviewed by the study investigators.

Dismantling and personalising task-sharing psychosocial interventions for common mental disorders: a study protocol for an individual participant data component network meta-analysis

Por: Papola · D. · Karyotaki · E. · Purgato · M. · Sijbrandij · M. · Tedeschi · F. · Cuijpers · P. · Orestis · E. · Furukawa · T. A. · Patel · V. · Barbui · C.
Introduction

Common mental disorders, including depression, anxiety and related somatic health symptoms, are leading causes of disability worldwide. Especially in low-resource settings, psychosocial interventions delivered by non-specialist providers through task-sharing modalities proved to be valid options to expand access to mental healthcare. However, such interventions are usually eclectic multicomponent interventions consisting of different combinations of evidence-based therapeutic strategies. Which of these various components (or combinations thereof) are more efficacious (and for whom) to reduce common mental disorder symptomatology is yet to be substantiated by evidence.

Methods and analysis

Comprehensive search was performed in electronic databases MEDLINE, Embase, PsycINFO and the Cochrane Register of Controlled Trials—CENTRAL from database inception to 15 March 2023 to systematically identify all randomised controlled trials that compared any single component or multicomponent psychosocial intervention delivered through the task-sharing modality against any active or inactive control condition in the treatment of adults suffering from common mental disorders. From these trials, individual participant data (IPD) of all measured outcomes and covariates will be collected. We will dismantle psychosocial interventions creating a taxonomy of components and then apply the IPD component network meta-analysis (IPD-cNMA) methodology to assess the efficacy of individual components (or combinations thereof) according to participant-level prognostic factors and effect modifiers.

Ethics and dissemination

Ethics approval is not applicable for this study since no original data will be collected. Results from this study will be published in peer-reviewed journals and presented at relevant conferences.

Evaluation of variation in special educational needs provision and its impact on health and education using administrative records for England: umbrella protocol for a mixed-methods research programme

Por: Zylbersztejn · A. · Lewis · K. · Nguyen · V. · Matthews · J. · Winterburn · I. · Karwatowska · L. · Barnes · S. · Lilliman · M. · Saxton · J. · Stone · A. · Boddy · K. · Downs · J. · Logan · S. · Rahi · J. · Black-Hawkins · K. · Dearden · L. · Ford · T. · Harron · K. · De Stavola · B. · Gilb
Introduction

One-third of children in England have special educational needs (SEN) provision recorded during their school career. The proportion of children with SEN provision varies between schools and demographic groups, which may reflect variation in need, inequitable provision and/or systemic factors. There is scant evidence on whether SEN provision improves health and education outcomes.

Methods

The Health Outcomes of young People in Education (HOPE) research programme uses administrative data from the Education and Child Health Insights from Linked Data—ECHILD—which contains data from all state schools, and contacts with National Health Service hospitals in England, to explore variation in SEN provision and its impact on health and education outcomes. This umbrella protocol sets out analyses across four work packages (WP). WP1 defined a range of ‘health phenotypes’, that is health conditions expected to need SEN provision in primary school. Next, we describe health and education outcomes (WP1) and individual, school-level and area-level factors affecting variation in SEN provision across different phenotypes (WP2). WP3 assesses the impact of SEN provision on health and education outcomes for specific health phenotypes using a range of causal inference methods to account for confounding factors and possible selection bias. In WP4 we review local policies and synthesise findings from surveys, interviews and focus groups of service users and providers to understand factors associated with variation in and experiences of identification, assessment and provision for SEN. Triangulation of findings on outcomes, variation and impact of SEN provision for different health phenotypes in ECHILD, with experiences of SEN provision will inform interpretation of findings for policy, practice and families and methods for future evaluation.

Ethics and dissemination

Research ethics committees have approved the use of the ECHILD database and, separately, the survey, interviews and focus groups of young people, parents and service providers. These stakeholders will contribute to the design, interpretation and communication of findings.

Barriers to and facilitators of effective management of fever episodes in hospitalised Kenyan children with cancer: protocol for convergent mixed methods study

Por: Nessle · C. N. · Njuguna · F. · Dettinger · J. · Koima · R. · Nyamusi · L. · Kisembe · E. · Kinja · S. · Ndungu · M. · Njenga · D. · Langat · S. · Olbara · G. · Moyer · C. · Vik · T.
Introduction

Febrile neutropenia is an oncological emergency in children with cancer, associated with serious infections and complications. In low-resourced settings, death from infections in children with cancer is 20 times higher than in high-resourced treatment settings, thought to be related to delays in antibiotic administration and management. The barriers to effective management of fever episodes in children with cancer have not previously been described. This convergent mixed-methods study will provide the evidence to develop fever treatment guidelines and to inform their effective implementation in children with cancer at Moi Teaching and Referral Hospital (MTRH), a level 6 referral hospital in western Kenya.

Methods and analysis

Prospective data collection of paediatric patients with cancer with new fever episodes admitted to MTRH will be performed during routine treatment. Clinical variables will be collected from 50 fever episodes, including cancer diagnosis and infectious characteristics of the fever episode, and elapsed time from fever onset to various milestones in the management workflow. Semistructured qualitative interviews with healthcare providers (estimated 20 to reach saturation) will explore the barriers to and facilitators of appropriate management of fever episodes in children with cancer. The interview guide was informed by a theoretical framework and Consolidated Framework for Implementation Research. A mixed-methods analysis use of joint display tables and process mapping will link and integrate the two types of data with meta-inferences.

Ethics and dissemination

Institutional review board approval was obtained from the MTRH (0004273) and the University of Michigan (HUM0225674), and the study was registered with National Commission for Science Technology and Innovation (P/23/22885). Written consent will be obtained from all participants. Results will be formally shared with local and national policy leadership and local end users, presented at relevant national academic conferences and submitted for publication in a peer-reviewed journal.

Associations of anaemia with bleeding and thrombotic complications in patients with atrial fibrillation treated with warfarin: a registry-based nested case-control study

Por: Helin · T. A. · Raatikainen · P. · Lehto · M. · Haukka · J. · Lassila · R.
Objectives

We studied association of laboratory testing beyond the international normalised ratio (INR) with bleeding and stroke/transient ischaemic attack (TIA) outcomes in patients with atrial fibrillation treated with warfarin.

Design

This was a retrospective nested case–control study from the Finnish Warfarin in Atrial Fibrillation (FinWAF) registry (n=54 568), reporting the management and outcome in warfarin-anticoagulated patients. Associations of blood count test frequency and results were assessed together with risk of bleeding or stroke/TIA during 5-year follow-up.

Setting

National FinWAF registry, with data from all six hospital districts. Follow-up period for complications was 1 January 2007–31 December 2011.

Participants

A total of 54 568 warfarin-anticoagulated patients.

Results

The number of patients with bleeding was 4681 (9%) and stroke/TIA episodes, 4692 (9%). In patients with bleeds, lower haemoglobin (within 3 months) preceded the event compared with the controls (median 126 vs 135 g/L; IQR 111–141 g/L vs 123–147 g/L, p

Conclusions

The deeper the anaemia, the higher the risk of bleeding and stroke/TIA. However, INR remained mainly at its target and only occasionally deviated, failing to detect the complication risk. Repeated low haemoglobin results, compatible with persistent anaemia, refer to suboptimal management and increased the complication risk in anticoagulated patients.

Tiza-Titre increase and enhanced immunity through an adjuvanted, recombinant herpes zoster subunit vaccine in patients with liver cirrhosis and post-liver transplantation: a study protocol for a prospective cohort study

Por: Vollmer-Raschdorf · S. · Rashidi-Alavijeh · J. · Voigt · S. · Hengel · H. · Borchardt · B. · Huzly · D. · Hüssler · E.-M. · in der Schmitten · J. · Halenius · A. · Willuweit · K. · Botzenhardt · S. · Trilling · M. · Boettler · T. · Dehnen · D.
Introduction

Shingrix, an effective adjuvanted, recombinant herpes zoster vaccine (RZV), has been available since 2018. Immunocompromised patients are known to be predisposed to vaccine failure. In-vitro testing of immunological surrogates of vaccine protection could be instrumental for monitoring vaccination success. So far, no test procedure is available for vaccine responses to RZV that could be used on a routine basis.

Methods and analysis

This is a single-centre, three-arm, parallel, longitudinal cohort study aspiring to recruit a total of 308 patients (103 with a liver cirrhosis Child A/B, 103 after liver transplantation (both ≥50 years), 102 immunocompetent patients (60–70 years)). Blood samples will be taken at seven data collection points to determine varicella zoster virus (VZV) and glycoprotein E (gE)-specific IgG and T cell responses. The primary study outcome is to measure and compare responses after vaccination with RZV depending on the type and degree of immunosuppression using gE-specific antibody detection assays. As a secondary outcome, first, the gE-specific CD4+ T cell response of the three cohorts will be compared and, second, the gE-VZV antibody levels will be compared with the severity of possible vaccination reactions. The tertiary outcome is a potential association between VZV immune responses and clinical protection against shingles.

Ethics and dissemination

Ethical approval was issued on 07/11/2022 by the Ethics Committee Essen, Germany (number 22-10805-BO). Findings will be published in peer-reviewed open-access journals and presented at local, national and international conferences.

Trial registration number

German Clinical Trials Registry (number DRKS00030683).

Study protocol to investigate the efficacy of confocal laser endomicroscopy-based selective single-elimination diet over standard fivefold elimination diet in patients with endomicroscopically proven food intolerance: app-assisted, monocentric, double-bli

Por: Hessler · N. · Kordowski · A. · Sasse · J. · Ahlemann · G. · Schulz · F. · Schröder · T. · Exner · A. · Jablonski · L. · Jappe · U. · Bischoff · S. C. · Grzegorzek · M. · König · I. R. · Sina · C.
Introduction

Imprecise nutritional recommendations due to a lack of diagnostic test accuracy are a frequent problem for individuals with adverse reactions to foods but no precise diagnosis. Consequently, patients follow very broad and strict elimination diets to avoid uncontrolled symptoms such as diarrhoea and abdominal pain. Dietary limitations and the uncertainty of developing gastrointestinal symptoms after the inadvertent ingestion of food have been demonstrated to reduce the quality of life (QoL) of affected individuals and subsequently might increase the risk of malnutrition and intestinal dysbiosis. This trial aims to investigate the effects of a tailored diet based on the confocal laser endoscopy (CLE) examination result to limit the side effects of unspecific and broad elimination diets and to increase the patient’s QoL.

Methods and analysis

The study is designed as a prospective, double-blind, monocentric, randomised and controlled trial conducted at the University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. One hundred seventy-two patients with non-IgE-related food allergies and positive CLE results will be randomised to either a tailored diet or a standard fivefold elimination diet. The primary endpoints are the difference between the end and the start of the intervention in health-related QoL and the sum score of the severity of symptoms after 12 weeks. Key secondary endpoints are changes in the severity of symptoms, further QoL measurements, self-assessed state of health and number of days with a pathologically altered stool. Microbiome diversity and metabolome of stool, urine and blood will also be investigated. Safety endpoints are body composition, body mass index and adverse events.

Ethics and dissemination

The study protocol was accepted by the ethical committee of the University of Lübeck (AZ: 22-111) on 4 May2022. Results of the study will be published in peer-reviewed journals and presented at scientific meetings.

Trial registration number

German Clinical Trials Register (DRKS00029323).

Intranasal antihistamines and corticosteroids in the treatment of allergic rhinitis: a systematic review and meta-analysis protocol

Por: Sousa-Pinto · B. · Vieira · R. J. · Brozek · J. · Cardoso-Fernandes · A. · Lourenco-Silva · N. · Ferreira-da-Silva · R. · Ferreira · A. · Gil-Mata · S. · Bedbrook · A. · Klimek · L. · Fonseca · J. A. · Zuberbier · T. · Schünemann · H. J. · Bousquet · J.
Introduction

Intranasal antihistamines and corticosteroids are some of the most frequently used drug classes in the treatment of allergic rhinitis. However, there is uncertainty as to whether effectiveness differences may exist among different intranasal specific medications. This systematic review aims to analyse and synthesise all evidence from randomised controlled trials (RCTs) on the effectiveness of intranasal antihistamines and corticosteroids in rhinitis nasal and ocular symptoms and in rhinoconjunctivitis-related quality-of-life.

Methods and analysis

We will search four electronic bibliographic databases and three clinical trials databases for RCTs (1) assessing patients ≥12 years old with seasonal or perennial allergic rhinitis and (2) comparing the use of intranasal antihistamines or corticosteroids versus placebo. Assessed outcomes will include the Total Nasal Symptom Score (TNSS), the Total Ocular Symptom Score (TOSS) and the Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ). We will assess the methodological quality of included primary studies by using the Cochrane risk-of-bias tool. Certainty in the body of evidence for the analysed outcomes will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. We will perform a random-effects meta-analysis for each assessed medication and outcome, presenting results as pooled mean differences and standardised mean differences. Heterogeneity will be explored by sensitivity and subgroup analyses, considering (1) the risk of bias, (2) the follow-up period and (3) the drug dose.

Ethics and dissemination

Ethical considerations will not be required. Results will be disseminated in a peer-review journal.

PROSPERO registration number

CRD42023416573.

Protocol for a longitudinal cohort study of Lyme disease with physical, mental and immunological assessment

Por: Loeb · M. · Brison · R. · Bramson · J. · Hatchette · T. · Sander · B. · Stringer · E.
Introduction

There are limited data on the longitudinal impact of Lyme disease. Predictors of recovery have not been fully established using validated data collection instruments. There are sparse data on the immunological response to infection over time.

Methods and analysis

This study is a longitudinal cohort study that will recruit 120 participants with Lyme disease in Ontario and Nova Scotia, Canada, with follow-up for up to 24 months. Data will be collected using the Short-Form 36 physical and mental component summaries, Depression and Anxiety Severity Scale Questionnaire, Fatigue Severity Scale and a battery of neuropsychological tests. Mononuclear cells, gene expression and cytokine profiling from blood samples will be used to assess immunological response. Analyses will include the use of non-linear mixed-effects modelling and proportional hazards models.

Ethics and dissemination

Ethics approval has been obtained from ethics boards at McMaster University (Hamilton Integrated Research Ethics Board) (7564), Queens University (EMD 315-20) and Nova Scotia Health Research Ethics Board (1027173), and the study is enrolling participants. Written informed consent is obtained from all participants. The results will be disseminated by publication in a peer-reviewed journal and presented at a relevant conference. A brief report will be provided to decision-makers and patient groups.

Cost-effectiveness analysis of the Geriatric Fracture Center (GFC) concept: a prospective multicentre cohort study

Por: Joeris · A. · Sprague · S. · Blauth · M. · Gosch · M. · Wattanapanom · P. · Jarayabhand · R. · Poeze · M. · Wong · M. K. · Kwek · E. B. K. · Hegeman · J. H. · Perez-Uribarri · C. · Guerado · E. · Revak · T. J. · Zohner · S. · Joseph · D. · Phillips · M. R.
Introduction

Geriatric Fracture Centers (GFCs) are dedicated treatment units where care is tailored towards elderly patients who have suffered fragility fractures. The primary objective of this economic analysis was to determine the cost-utility of GFCs compared with usual care centres.

Methods

The primary analysis was a cost-utility analysis that measured the cost per incremental quality-adjusted life-year gained from treatment of hip fracture in GFCs compared with treatment in usual care centres from the societal perspective over a 1-year time horizon. The secondary analysis was a cost-utility analysis from a societal perspective over a lifetime time horizon. We evaluated these outcomes using a cost-utility analysis using data from a large multicentre prospective cohort study comparing GFCs versus usual care centres that took place in Austria, Spain, the USA, the Netherlands, Thailand and Singapore.

Results

GFCs may be cost-effective in the long term, while providing a more comprehensive care plan. Patients in usual care centre group were slightly older and had fewer comorbidities. For the 1-year analysis, the costs per patient were slightly lower in the GFC group (–$646.42), while the quality-adjusted life-years were higher in the usual care centre group (+0.034). The incremental cost-effectiveness ratio was $18 863.34 (US$/quality-adjusted life-year). The lifetime horizon analysis found that the costs per patient were lower in the GFC group (–$7210.35), while the quality-adjusted life-years were higher in the usual care centre group (+0.02). The incremental cost-effectiveness ratio was $320 678.77 (US$/quality-adjusted life-year).

Conclusions

This analysis found that GFCs were associated with lower costs compared with usual care centres. The cost-savings were greater when the lifetime time horizon was considered. This comprehensive cost-effectiveness analysis, using data from an international prospective cohort study, found that GFC may be cost-effective in the long term, while providing a more comprehensive care plan. A greater number of major adverse events were reported at GFC, nevertheless a lower mortality rate associated with these adverse events at GFC. Due to the minor utility benefits, which may be a result of greater adverse event detection within the GFC group and much greater costs of usual care centres, the GFC may be cost-effective due to the large cost-savings it demonstrated over the lifetime time horizon, while potentially identifying and treating adverse events more effectively. These findings suggest that the GFC may be a cost-effective option over the lifetime of a geriatric patient with hip fracture, although future research is needed to further validate these findings.

Level of evidence

Economic, level 2.

Trial registration number

NCT02297581.

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