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☐ ☆ ✇ Journal of Nursing Scholarship

Ethical, innovative, and globally significant

Por: Susan Gennaro — Mayo 11th 2024 at 07:11
Journal of Nursing Scholarship, Volume 56, Issue 3, Page 355-356, May 2024.
☐ ☆ ✇ Journal of Advanced Nursing

Comparison of student nurses' expectations and newly qualified nurses' experiences regarding clinical practice: A secondary analysis of a cross‐sectional survey

Abstract

Aim

To compare student nurses' expectations and newly qualified nurses' experiences regarding clinical practice in Switzerland 1 year after graduation.

Design

A secondary explorative analysis of a cross-sectional survey.

Methods

The data were sourced from the Swiss National Graduate Survey of Health Professionals covering six universities of applied sciences between 2016 and 2019, with information on three cohorts of bachelor student nurses, with a 1-year follow-up between each year. The participants were 533 bachelor-prepared nursing graduates.

Results

The student nurses' overall expectations included the following top two prioritized aspects: ‘contributing to something important’ and ‘adequate time to spend with patients’. Newly graduated nurses' clinical practice experiences demonstrated that not all expectations were met 1 year after graduation. The largest gaps were found in ‘adequate time to spend with patients’, ‘work–life balance’ and experiencing ‘good management’.

Conclusion

The most crucial expectation gaps are related to having sufficient time to spend with patients and a good work–life balance. The most important result is whether there is a shortage of places for nurses to work rather than the oft-cited shortage of nurses.

Implications for the Profession and/or Patient Care

The expectations of Swiss newly qualified nurses can be better met by an assessment in the first year about which individual perceptions of workplace characteristics cause them to make choices to change something about their work, affect their job satisfaction or influence their intention to stay.

Impact

Few of the student nurses' expectations were met 1 year after graduation, therefore Swiss healthcare institutions should improve needs assessments to strengthen the nurse workforce starting early in employment. The results underscore the importance of a constructive management culture, such as that in magnet hospitals in the United States which underpins the philosophy of changing in nursing. The results can be used internationally as a benchmark and as a basis for introducing potential interventions for nurse retention.

Reporting Method

This study was reported following the Standardized Reporting of Secondary Data Analyses Checklist.

Patient or Public Contribution

There were no patient or public contributions.

Trial and Protocol Registration

This study has not been registered.

☐ ☆ ✇ Journal of Advanced Nursing

Workplace violence, work‐related exhaustion, and workplace cognitive failure among nurses: A cross‐sectional study

Por: Judith E. Arnetz · Nathan Baker · Eamonn Arble · Bengt B. Arnetz — Mayo 7th 2024 at 11:31

Abstract

Aim

To examine the relationships between nurses' exposure to workplace violence and self-reports of workplace cognitive failure.

Design

A cross-sectional study.

Methods

An online questionnaire was administered in April 2023 to nurses in Michigan, US. Structural equation modelling was used to examine effects of physical and non-physical workplace violence (occupational stressors) and work efficiency and competence development (occupational protective factors) on workplace cognitive failure.

Results

Physical violence was a significant predictor of the action subscale of cognitive failure. There were no direct effects of non-physical violence, workplace efficiency, or competence development on any of the workplace cognitive failure dimensions. Both types of violence and efficiency had significant indirect effects on workplace cognitive failure via work-related exhaustion. Work-related exhaustion predicted significantly higher scores for workplace cognitive failure.

Conclusion

Workplace violence and work efficiency exhibited primarily indirect effects on workplace cognitive failure among nurses via work-related exhaustion.

Implications for the Profession and/or Patient Care

Nurses experiencing workplace violence may be at increased risk for workplace cognitive failure, especially if they are also experiencing work-related exhaustion. Workplaces that nurses perceive as more efficient can help to mitigate the effects of violence on nurses' cognitive failure.

Impact

This study addressed the possible effects of workplace violence as well as work efficiency and competence development on nurses' cognitive failure at work. Analyses revealed primarily indirect effects of workplace violence, and indirect protective effects of work efficiency, on nurses' cognitive failure via work-related exhaustion. This research has implications for healthcare organizations and suggests that efforts made by healthcare workplaces to prevent violence and work-related exhaustion, and to enhance work efficiency, may help to mitigate workplace cognitive failure among nurses.

Reporting Method

We have followed the STROBE checklist in reporting this study.

Patient or Public Contribution

No Patient or public contribution.

☐ ☆ ✇ Journal of Advanced Nursing

What alleviates the harmful effect of strain on recovery from work of 4478 health and social services workers? A cross‐sectional study

Por: Kirsikka Selander · Eveliina Korkiakangas · Jaana Laitinen — Mayo 7th 2024 at 10:29

Abstract

Aim

To analyse whether the harmful effect of job demands on recovery can be alleviated by healthy lifestyle, psychological recovery experiences and job resources. We also describe their prevalence among employees in different types of eldercare service and in the health and social services sector in general.

Design

Cross-sectional study.

Methods

The data were collected using a self-report survey in 2020 in the health and social services sector organizations (n = 4478). Employees were classified as the following service types: general health and social services (N = 3225), home care (N = 452), service housing (N = 550) and outpatient and ward care (N = 202). The data were analysed using percentages, cross-tabulations and logistic regression analysis.

Results

Poor recovery, high job demands, low appreciation and low autonomy in terms of worktime and breaks were more prevalent in eldercare. Employers could alleviate the risk of high job demands by offering job resources—appreciation, autonomy in terms of worktimes and breaks—and motivating employees to maintain healthy lifestyle habits and use recovery experiences such as relaxation.

Conclusion

The study emphasizes the importance of appreciation in the health and social services sector context. Even with moderate levels of appreciation employers can protect employees from poor recovery from work in the demanding health and social services work environment.

Impact

Eldercare employees face continuous and accumulating work strain at the same time as the sector struggles against a labour shortage. One way to prevent the harmful consequences of strain is to enhance recovery from work.

Employers could alleviate the risk of high job demands and poor recovery by showing appreciation and giving employees more autonomy in terms of work time and breaks during the workday. This could also motivate employees to keep up healthy lifestyle habits and use their recovery experiences. Results are important especially in the daily management of HSS work.

What Does this Paper Contribute to the wider Global Clinical Community?

Managers in the health and social services sector and eldercare can use these findings to promote recovery from work.

Reporting Method

STROBE checklist.

Patient or Public Contribution

No patient or public contribution.

☐ ☆ ✇ Journal of Nursing Scholarship

Personal and work‐related factors associated with post‐traumatic growth in nurses: A mixed studies systematic review

Abstract

Introduction

Nurses, assuming a wide range of clinical and patient care responsibilities in a healthcare team, are highly susceptible to direct and indirect exposure to traumatic experiences. However, literature has shown that nurses with certain traits developed a new sense of personal strength in the face of adversity, known as post-traumatic growth (PTG). This review aimed to synthesize the best available evidence to evaluate personal and work-related factors associated with PTG among nurses.

Design

Mixed studies systematic review.

Methods

Studies examining factors influencing PTG on certified nurses from all healthcare facilities were included. Published and unpublished studies were identified by searching 12 databases from their inception until 4th February 2023. Two reviewers independently screened, appraised, piloted a data collection form, and extracted relevant data. Meta-summary, meta-synthesis, meta-analysis, as well as subgroup and sensitivity analyses were performed. Integration of results followed result-based convergent design.

Results

A total of 98 studies with 29,706 nurses from 18 countries were included. These included 49 quantitative, 42 qualitative, and seven mixed-methods studies. Forty-six influencing factors were meta-analyzed, whereas nine facilitating factors were meta-summarized. A PTG conceptual map was created. Four constructs emerged from the integration synthesis: (a) personal system, (b) work-related system, (c) event-related factors, and (d) cognitive transformation.

Conclusion

The review findings highlighted areas healthcare organizations could do to facilitate PTG in nurses. Practical implications include developing intervention programs based on PTG facilitators. Further research should examine the trend of PTG and its dynamic response to different nursing factors.

Clinical Relevance

Research on trauma-focused therapies targeting nurses' mental health is lacking. Therefore, findings from this review could inform healthcare organizations on the PTG phenomenon and developing support measures for nurses through healthcare policies and clinical practice.

☐ ☆ ✇ Journal of Advanced Nursing

Determinants of the optimal selection of vascular access devices: A systematic review underpinned by the COM‐B behavioural model

Abstract

Background

Optimal selection of vascular access devices is based on multiple factors and is the first strategy to reduce vascular access device-related complications. This process is dependent on behavioural and human factors. The COM-B (Capability, Opportunity, Motivation, Behaviour) model was used as a theoretical framework to organize the findings of this systematic review.

Methods/Aims

To synthesize the evidence on determinants shaping the optimal selection of vascular access devices, using the COM-B behavioural model as the theoretical framework.

Design

Systematic review of studies which explore decision-making at the time of selecting vascular access devices.

Data Sources

The Medline, Web of Science, Scopus and EbscoHost databases were interrogated to extract manuscripts published up to 31 December 2021, in English or Spanish.

Results

Among 16 studies included in the review, 8/16 (50%) focused on physical capability, 8/16 (50%) psychological capability, 15/16 (94%) physical opportunity, 12/16 (75%) social opportunity, 1/16 (6%) reflective motivation and 0/16 (0%) automatic motivation. This distribution represents a large gap in terms of interpersonal and motivational influences and cultural and social environments. Specialist teams (teams created for the insertion or maintenance of vascular access devices) are core for the optimal selection of vascular access devices (75% physical capability, 62% psychological capability, 80% physical opportunity and 100% social opportunity).

Conclusion

Specialist teams predominantly lead all actions undertaken towards the optimal selection of vascular access devices. These actions primarily centre on assessing opportunity and capability, often overlooking motivational influences and social environments.

Implications for the Profession and/or Patient Care

A more implementation-focused professional approach could decrease inequity among patients and complications associated with vascular access devices.

Impact

Optimal selection of vascular access devices is the primary strategy in mitigating complications associated with these devices. There is a significant disparity between interpersonal and motivational influences and the cultural and social environments. Furthermore, specialized teams play a pivotal role in facilitating the optimal selection of vascular access devices. The study can benefit institutions concerned about vascular access devices and their complications.

Reporting Method

This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Patient or public contribution

No Patient or Public Contribution.

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

Optimal selection of vascular devices remains a growing yet unresolved issue with costly clinical and patient experience impact. Interventions to improve the optimal selection of vascular devices have focused on training, education, algorithms and implementation of specialist vascular teams; alas, these approaches do not seem to have substantially addressed the problem. Specialist vascular teams should evolve and pivot towards leading the implementation of quality improvement interventions, optimizing resource use and enhancing their role.

☐ ☆ ✇ Journal of Nursing Scholarship

Particularity, Engagement, Actionable Inferences, Reflexivity, and Legitimation tool for rigor in mixed methods implementation research

Por: Ahtisham Younas · Sergi Fàbregues — Mayo 1st 2024 at 17:18

Abstract

Background

Implementation science helps generate approaches to expedite the uptake of evidence in practice. Mixed methods are commonly used in implementation research because they allow researchers to integrate distinct qualitative and quantitative methods and data sets to unravel the implementation process and context and design contextual tools for optimizing the implementation. To date, there has been limited discussion on how to ensure rigor in mixed methods implementation research.

Purpose

To present Particularity, Engagement, Actionable Inferences, Reflexivity, and Legitimation (PEARL) as a practical tool for understanding various components of rigor in mixed methods implementation research.

Data Sources

This methodological discussion is based on a nurse-led mixed methods implementation study. The PEARL tool was developed based on an interpretive, critical reflection, and purposive reading of selected literature sources drawn from the researchers' knowledge, experiences of designing and conducting mixed methods implementation research, and published methodological papers about mixed methods, implementation science, and research rigor.

Conclusion

An exemplar exploratory sequential mixed methods study in nursing is provided to illustrate the application of the PEARL tool. The proposed tool can be a useful and innovative tool for researchers and students intending to use mixed methods in implementation research. The tool offers a straightforward approach to learning the key rigor components of mixed methods implementation research for application in designing and conducting implementation research using mixed methods.

Clinical Relevance

Rigorous implementation research is critical for effective uptake of innovations and evidence-based knowledge into practice and policymaking. The proposed tool can be used as the means to establish rigor in mixed methods implementation research in nursing and health sciences.

☐ ☆ ✇ CIN: Computers, Informatics, Nursing

Artificial Intelligence and the National Violent Death Reporting System: A Rapid Review

imageAs the awareness on violent deaths from guns, drugs, and suicides emerges as a public health crisis in the United States, attempts to prevent injury and mortality through nursing research are critical. The National Violent Death Reporting System provides public health surveillance of US violent deaths; however, understanding the National Violent Death Reporting System's research utility is limited. The purpose of our rapid review of the 2019-2023 literature was to understand to what extent artificial intelligence methods are being used with the National Violent Death Reporting System. We identified 16 National Violent Death Reporting System artificial intelligence studies, with more than half published after 2020. The text-rich content of National Violent Death Reporting System enabled researchers to center their artificial intelligence approaches mostly on natural language processing (50%) or natural language processing and machine learning (37%). Significant heterogeneity in approaches, techniques, and processes was noted across the studies, with critical methods information often lacking. The aims and focus of National Violent Death Reporting System studies were homogeneous and mostly examined suicide among nurses and older adults. Our findings suggested that artificial intelligence is a promising approach to the National Violent Death Reporting System data with significant untapped potential in its use. Artificial intelligence may prove to be a powerful tool enabling nursing scholars and practitioners to reduce the number of preventable, violent deaths.
☐ ☆ ✇ CIN: Computers, Informatics, Nursing

Identifying Main Themes in Diabetes Management Interviews Using Natural Language Processing–Based Text Mining

Por: Cha, EunSeok · Lee, Seonah — Marzo 6th 2024 at 01:00
imageThis study aimed to identify the main themes from exit interviews of adult patients with type 2 diabetes after completion of a diabetes education program. Eighteen participants with type 2 diabetes completed an exit interview regarding their program experience and satisfaction. Semistructured interview questions were used, and the interviews were auto-recorded. The interview transcripts were preprocessed and analyzed using four natural language processing–based text-mining techniques. The top 30 words from the term frequency and term frequency–inverse document frequency each were derived. In the N-gram analysis, the connection strength of “diabetes” and “education” was the highest, and the simultaneous connectivity of word chains ranged from a maximum of seven words to a minimum of two words. Based on the CONvergence of iteration CORrelation (CONCOR) analysis, three clusters were generated, and each cluster was named as follows: participation in a diabetes education program to control blood glucose, exercise, and use of digital devices. This study using text mining proposes a new and useful approach to visualize data to develop patient-centered diabetes education.
☐ ☆ ✇ BMJ Open

Exploring community participation in vectorborne disease control in Southeast Asia: a scoping review protocol

Por: Naserrudin · N. A. · Adhikari · B. · Culleton · R. · Hod · R. · Saffree Jeffree · M. · Ahmed · K. · Hassan · M. R. — Mayo 14th 2024 at 01:39
Introduction

Vector borne diseases (VBDs) present significant public health challenges in Southeast Asia (SEA), and the increasing number of cases threatens vulnerable communities. Inadequate vector control and management have been linked to the spread of VBDs. To address these issues, community participation has been proposed as a promising approach to enhance health programmes and control of VBDs. This article outlines a protocol for a scoping review of the published literature on community-participation approaches to control VBDs in the SEA region. The primary research question is ‘How does community participation complement the control of VBDs in SEA?’ This review aims to provide an overview of various approaches and identify barriers and facilitators to effective implementation.

Methods and analysis

The research questions will guide the scoping review. In stage 1, peer-reviewed publications from PubMed, Web of Science and Scopus will be searched using predefined search terms related to community-based approaches and VBDs in the SEA region, English, Indonesian and Malay published between 2012 and 2022. In stage 2, the references from relevant articles will be screened for eligibility. In stage 3, eligible articles will be charted in Microsoft Excel to facilitate the review process, and studies will be characterised based on the investigated diseases; this review will also highlight the methodological context of these studies. In stage 4, a thematic analysis will be conducted to derive meaningful findings from the dataset relevant to the research inquiry, followed by writing the results in stage 5. This scoping review aims to be the first to explore community participation in VBD control in the SEA population, providing valuable insights for future research and stakeholders involved in disease control.

Ethics and dissemination

This scoping review does not require ethical approval because the methodology synthesises information from available articles. This review is planned for dissemination in academic journals, conference presentations and shared with stakeholders as part of knowledge sharing among those involved in VBD control.

☐ ☆ ✇ BMJ Open

Low-dose naltrexone for post-COVID fatigue syndrome: a study protocol for a double-blind, randomised trial in British Columbia

Por: Naik · H. · Cooke · E. · Boulter · T. · Dyer · R. · Bone · J. N. · Tsai · M. · Cristobal · J. · McKay · R. J. · Song · X. · Nacul · L. — Mayo 14th 2024 at 01:39
Introduction

A significant proportion of individuals suffering from post COVID-19 condition (PCC, also known as long COVID) can present with persistent, disabling fatigue similar to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-viral fatigue syndromes. There remains no clear pharmacological therapy for patients with this subtype of PCC, which can be referred to as post-COVID fatigue syndrome (PCFS). A low dose of the opioid antagonist naltrexone (ie, low-dose naltrexone (LDN)) has emerged as an off-label treatment for treating fatigue and other symptoms in PCC. However, only small, non-controlled studies have assessed LDN in PCC, so randomised trials are urgently required.

Methods and analysis

A prospective, randomised, double-blind, parallel arm, placebo-controlled phase II trial will be performed to assess the efficacy of LDN for improving fatigue in PCFS. The trial will be decentralised and open to eligible individuals throughout the Canadian province of British Columbia (BC). Participants will be recruited through the province-wide Post-COVID-19 Interdisciplinary Clinical Care Network (PC-ICCN) and research volunteer platform (REACH BC). Eligible participants will be 19–69 years old, have had a confirmed or physician-suspected SARS-CoV-2 infection at least 3 months prior and meet clinical criteria for PCFS adapted from the Institute of Medicine ME/CFS criteria. Individuals who are taking opioid medications, have a history of ME/CFS prior to COVID-19 or history of significant liver disease will be excluded. Participants will be randomised to an LDN intervention arm (n=80) or placebo arm (n=80). Participants in each arm will be prescribed identical capsules starting at 1 mg daily and follow a prespecified schedule for up-titration to 4.5 mg daily or the maximum tolerated dose. The trial will be conducted over 16 weeks, with assessments at baseline, 6, 12 and 16 weeks. The primary outcome will be fatigue severity at 16 weeks evaluated by the Fatigue Severity Scale. Secondary outcomes will include pain Visual Analogue Scale score, overall symptom severity as measured by the Patient Phenotyping Questionnaire Short Form, 7-day step count and health-related quality of life measured by the EuroQol 5-Dimension questionnaire.

Ethics and dissemination

The trial has been authorised by Health Canada and approved by The University of British Columbia/Children’s and Women’s Health Centre of British Columbia Research Ethics Board. On completion, findings will be disseminated to patients, caregivers and clinicians through engagement activities within existing PCC and ME/CFS networks. Results will be published in academic journals and presented at conferences.

Trial registration number

NCT05430152.

☐ ☆ ✇ BMJ Open

Cost-effectiveness of a complex continuum of care intervention targeting women and children: protocol for an economic evaluation of the Bukhali trial in South Africa

Por: Palmer · T. · Leiva Granados · R. · Draper · C. · Norris · S. A. · Batura · N. — Mayo 14th 2024 at 01:39
Introduction

As nearly two-thirds of women presenting at their first antenatal visit are either overweight or obese in urban South Africa, the preconception period is an opportunity to optimise health and offset transgenerational risk of both obesity and non-communicable diseases. This protocol describes the planned economic evaluation of an individually randomised controlled trial of a complex continuum of care intervention targeting women and children in Soweto, South Africa (Bukhali trial).

Methods and analysis

The economic evaluation of the Bukhali trial will be conducted as a within-trial analysis from both provider and societal perspectives. Incremental costs and health outcomes of the continuum of care intervention will be compared with standard care. The economic impact on implementing agencies (programme costs), healthcare providers, participants and their households will be estimated. Incremental cost-effectiveness ratios (ICERs) will be calculated in terms of cost per case of child adiposity at age years averted. Additionally, ICERs will also be reported in terms of cost per quality-adjusted life year gained. If Bukhali demonstrates effectiveness, we will employ a decision analytical model to examine the cost-effectiveness of the intervention over a child’s lifetime. A Markov model will be used to estimate long-term health benefits, healthcare costs and cost-effectiveness. Probabilistic sensitivity analyses will be conducted to explore uncertainty and ensure robust results. An analysis will be conducted to assess the equity impact of the intervention, by comparing intervention impact within quintiles of socioeconomic status.

Ethics and dissemination

The Bukhali trial economic evaluation has ethical approval from the Human Ethics Research Committee of the University of the Witwatersrand, Johannesburg, South Africa (M240162). The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference.

Trial registration number

Pan African Clinical Trials Registry (PACTR201903750173871; https://pactr.samrc.ac.za).

☐ ☆ ✇ BMJ Open

Interdisciplinary research approach based on a mixed-methods design to explore patient altruism at the end of life: a study protocol

Por: Bernard · M. · Gamondi · C. · Sterie · A.-C. · Larkin · P. J. · Jox · R. · Borasio · G. D. — Mayo 10th 2024 at 18:56
Introduction

In the end of life context, patients are often seen as somewhat passive recipients of care provided by health professionals and relatives, with little opportunity to be perceived as autonomous and active agents. Since studies show a very high prevalence of altruistic dispositions in palliative care patients, we strive to investigate the concept of patient altruism in a set of six interdisciplinary studies by considering three settings: (1) in the general palliative context—by studying to what extent patient altruism is associated with essential psychological outcomes of palliative care (subproject 1a), how altruism is understood by patients (subproject 1b) and how altruism expressed by patients is experienced by palliative care nurses (subproject 1c); (2) in two concrete decision-making contexts—advance care planning (subproject 2a) and assisted suicide (subproject 2b); and (3) through verbal and non-verbal patient communication in palliative care settings (subproject 3).

Methods and analysis

Subproject 1a: a cross-sectional study using validated and standardised questionnaires. Subprojects 1b and 1c: a constructivist grounded theory method aiming at developing a novel theory from semistructured interviews in both patients and nurses. Subproject 2a: a thematic analysis based on (1) audio-recordings of advance care planning encounters and (2) follow-up semidirective interviews with patients and their relatives. Subproject 2b: a qualitative study based on thematic analysis of interviews with patients actively pursuing assisted suicide and one of their relatives.Subproject 3: a conversation analysis based on audio and video-recorded interactions in two settings: (1) palliative inpatient unit and (2) advance care planning discussions.

Ethics and dissemination

The study project was approved by the Ethics Committees of the Canton of Vaud, Bern and Ticino (no: 2023-00088). In addition to participation in national and international conferences, each project will be the subject of two scientific publications in peer-reviewed journals. Additional publications will be realised according to result triangulation between projects. A symposium opened to professionals, patients and the public will be organised in Switzerland at the end of the project.

☐ ☆ ✇ BMJ Open

Tobacco policies and changes in the tendency of smoking cessation in cigarette users in Chile: a longitudinal cross-sectional study

Por: Dominguez-Cancino · K. A. · Martinez · P. · Nazif-Munoz · J. I. — Mayo 10th 2024 at 18:56
Objective

To assess the impact of tobacco control regulations and policy implementation on smoking cessation tendencies in cigarette users born between 1982 and 1991 in Chile.

Design

Longitudinal cross-sectional study.

Setting

National level.

Participants

Data from the National Survey of Drug Consumption (Service of Prevention and Rehabilitation for Drug and Alcohol Consumption). A pseudo-cohort of smokers born between 1982 and 1991 (N=17 905) was tracked from 2002 to 2016.

Primary and secondary outcomes measures

Primary outcome was the tendency to cease smoking conceptualised as the report of using cigarettes 1 month or more ago relative to using cigarettes in the last 30 days. The main exposure variable was the Tobacco Policy Index—tracking tobacco policy changes over time. Logistic regression, controlling for various factors, was applied.

Results

Models suggested a 14% increase in the smoking cessation tendency of individuals using cigarettes 1 month or more ago relative to those using cigarettes in the last 30 days (OR 1.14, CI 95% CI 1.10 to 1.19) for each point increment in the Tobacco Policy index.

Conclusions

Our study contributes to documenting a positive impact of the implementation of interventions considered in the MPOWER strategy in the progression of smoking cessation tendencies in smokers born between 1982 and 1991 in Chile.

☐ ☆ ✇ BMJ Open

Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies

Por: van Gils · L. · de Boer · M. A. · Bosmans · J. · Duijnhoven · R. · Schoenmakers · S. · Derks · J. B. · Prins · J. R. · Al-Nasiry · S. · Lutke Holzik · M. · Lopriore · E. · van Drongelen · J. · Knol · M. H. · van Laar · J. O. E. H. · Jacquemyn · Y. · van Holsbeke · C. · Dehaene · I. · L — Mayo 10th 2024 at 18:56
Introduction

Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.

Methods and analysis

We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at

Ethics and dissemination

This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.

Trial registration number

ClinicalTrials.gov, NCT05968794.

☐ ☆ ✇ BMJ Open

Autologous concentrated bone marrow injection for precollapse osteonecrosis of the femoral head concurrent with contralateral total hip arthroplasty: protocol for a clinical trial

Por: Homma · Y. · Yamasaki · T. · Tashiro · K. · Okada · Y. · Shirogane · Y. · Watari · T. · Hayashi · K. · Baba · T. · Nagata · K. · Yanagisawa · N. · Ohtsu · H. · Fujiwara · N. · Ando · J. · Yamaji · K. · Tamura · N. · Ishijima · M. — Mayo 8th 2024 at 17:36
Introduction

The femoral head contralateral to the collapsed femoral head requiring total hip arthroplasty (THA) often manifests in the precollapse stage of osteonecrosis of the femoral head (ONFH). It is not yet demonstrated how autologous concentrated bone marrow injection may prevent collapse of the femoral head concurrent with contralateral THA. The primary objective is to evaluate the efficacy of autologous concentrated bone marrow injection for the contralateral, non-collapsed, femoral head in patients with bilateral ONFH, with the ipsilateral collapsed femoral head undergoing THA.

Methods and analysis

This is a multicentre, prospective, non-randomised, historical-data controlled study. We will recruit patients with ONFH who are scheduled for THA and possess a non-collapsed contralateral femoral head. Autologous bone marrow will be collected using a point-of-care device. After concentration, the bone marrow will be injected into the non-collapsed femoral head following the completion of THA in the contralateral hip. The primary outcome is the percentage of femoral head collapse evaluated by an independent data monitoring committee using plain X-rays in two directions 2 years after autologous concentrated bone marrow injection. Postinjection safety, adverse events, pain and hip function will also be assessed. The patients will be evaluated preoperatively, and at 6 months, 1 year and 2 years postoperatively.

Ethics and dissemination

This protocol has been approved by the Certified Committee for Regenerative Medicine of Tokyo Medical and Dental University and Japan’s Ministry of Healthy, Labour and Welfare and will be performed as a class III regenerative medicine protocol, in accordance with Japan’s Act on the Safety of Regenerative Medicine. The results of this study will be submitted to a peer-review journal for publication. The results of this study are expected to provide evidence to support the inclusion of autologous concentrated bone marrow injections in the non-collapsed femoral head in Japan’s national insurance coverage.

Trial registration number

jRCTc032200229.

☐ ☆ ✇ BMJ Open

Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

Por: Marshall · H. · Ward · J. · Wang · B. · Andraweera · P. · McMillan · M. · Flood · L. · Bell · C. · Sisnowski · J. · Krause · V. · Webby · R. · Childs · E. · Gunathilake · M. · Egoroff · N. · Leong · L. · Lawrence · A. · Baird · R. · Freeman · K. · Menouhos · D. · Whiley · D. M. · Karnon · J. — Mayo 8th 2024 at 17:36
Introduction

The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections.

Methods and analyses

This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4–7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.

Ethics and dissemination

The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.

☐ ☆ ✇ BMJ Open

Sex and gender-based analysis and diversity metric reporting in acute care trials published in high-impact journals: a systematic review

Por: Granton · D. · Rodrigues · M. · Raparelli · V. · Honarmand · K. · Agarwal · A. · Friedrich · J. O. · Perna · B. · Spaggiari · R. · Fortunato · V. · Risdonne · G. · Kho · M. · VanderKaay · S. · Chaudhuri · D. · Gomez-Builes · C. · D'Aragon · F. · Wiseman · D. · Lau · V. I. · Lin · C. · Reid — Mayo 8th 2024 at 00:30
Objective

To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.

Design

Systematic review.

Data sources

We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.

Study selection

Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.

Data abstraction and synthesis

4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.

Results

We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).

Conclusions

Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.

PROSPERO registration number

CRD42022282565.

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