Conectar
The critical care nursing workforce is in crisis, with one-third of critical care nurses worldwide intending to leave their roles. This paper aimed to examine the problem from a wellbeing perspective, offering implications for research, and potential solutions for organisations.
Discursive/Position paper.
The discussion is based on the nursing and wellbeing literature. It is guided by the authors' collaborative expertise as both clinicians and researchers. Data were drawn from nursing and wellbeing peer-reviewed literature, such as reviews and empirical studies, national surveys and government and thinktank publications/reports.
Critical care nurses have been disproportionately affected by the COVID-19 pandemic with studies consistently showing critical care nurses to have the worst psychological outcomes on wellbeing measures, including depression, burnout and post-traumatic stress disorder (PTSD). These findings are not only concerning for the mental wellbeing of critical care nurses, they also raise significant issues for healthcare systems/organisations: poor wellbeing, increased burnout and PTSD are directly linked with critical care nurses intending to leave the profession. Thus, the wellbeing of critical care nurses must urgently be supported. Resilience has been identified as a protective mechanism against the development of PTSD and burnout, thus offering evidence-based interventions that address resilience and turnover have much to offer in tackling the workforce crisis. However, turnover data must be collected by studies evaluating resilience interventions, to further support their evidence base. Organisations cannot solely rely on the efficacy of these interventions to address their workforce crisis but must concomitantly engage in organisational change.
We conclude that critical care nurses are in urgent need of preventative, evidence-based wellbeing interventions, and make suggestions for research and practice.
Elopement jeopardizes patient safety, affects the hospital's reputation, and results in financial ramifications. In an academic community hospital, executive leadership approached a team of nurse leaders for expertise following the elopement of a vulnerable patient.
The team's goal was to identify evidence-based strategies to mitigate future elopement events. Following an extensive literature review and gap analysis, the organization recognized opportunities pertaining to elopement management, including patient assessment, prevention strategies, and facility-wide response when events occur. The nurse leader team thoroughly searched current literature to answer the Population, Intervention, Comparison, and Outcome (i.e., PICO) questions of interest. Following a critical appraisal of 55 articles, 26 were utilized to make practice change recommendations. The body of evidence included a variety of age groups and diagnoses.
After the synthesis of the literature, the team provided recommendations to the organization. These recommendations included the assessment of patient-specific risks and the implementation of elopement prevention measures as fundamental elements for incidence reduction. The team partnered with multidisciplinary stakeholders for the revision of policies, processes, and electronic medical record documentation.
The organization monitored elopement events and the duration of each event throughout the phases of implementation. Pre-implementation data, collected from January to June 2021, demonstrated 34 individual elopement cases lasting an average of 118 min each. In comparison, post-implementation data collected during the same time frame in 2022 found only 12 events lasting an average of 24 min each.
The organization implemented evidence-based recommendations to standardize the facility's approach to elopement. With structured assessment, precautions, and response, the organization demonstrated a notable decline in the number and duration of elopement events. Hardwiring processes, analyzing data, and adjusting expectations within an evidence-based framework should assist the organization's drive to further enhance patient safety surrounding elopement events.
Implementation of patient-reported outcome measures (PROMs) is limited in paediatric routine clinical care. The KidsPRO programme has been codesigned to facilitate the implementation of PROMs in paediatric healthcare settings. Therefore, this study (1) describes the development of innovative KidsPRO programme and (2) reports on the feasibility of implementing PedsQL (Pediatric Quality of Life Inventory) PROM in asthma clinics using the KidsPRO programme.
Feasibility assessment study.
Outpatient paediatric asthma clinics in the city of Calgary, Canada.
Five paediatric patients, four family caregivers and three healthcare providers were recruited to pilot the implementation of PedsQL PROM using KidsPRO. Then, a survey was used to assess its feasibility among these study participants.
Participants’ understanding of using PROMs, the adequacy of support provided to them, the utility of using PROMs as part of their appointment, and their satisfaction with using PROMs.
The quantitative data generated through closed-ended questions was analysed and represented in the form of bar charts for each category of study participants (ie, patients, their family caregivers and healthcare providers). The qualitative data generated through the open-ended questions were content analysed and categorised into themes.
The experience of using PROMs was overwhelmingly positive among patients and their family caregivers, results were mixed among healthcare providers. Qualitative data collected through open-ended questions also complemented the quantitative findings.
The evidence from this study reveals that the implementation of PROMs in routine paediatric clinical care asthma clinics in Alberta is seems to be feasible.
Malignant mesothelioma is a rapidly lethal cancer that has been increasing at an epidemic rate over the last three decades. Targeted therapies for mesothelioma have been lacking. A previous study called MiST1 (NCT03654833), evaluated the efficacy of Poly (ADP-ribose) polymerase (PARP) inhibition in mesothelioma. This study met its primary endpoint with 15% of patients having durable responses exceeding 1 year. Therefore, there is a need to evaluate PARP inhibitors in relapsed mesothelioma patients, where options are limited. Niraparib is the PARP inhibitor used in NERO.
NERO is a multicentre, two-arm, open-label UK randomised phase II trial designed to evaluate the efficacy of PARP inhibition in relapsed mesothelioma. 84 patients are being recruited. NERO is not restricted by line of therapy; however, eligible participants must have been treated with an approved platinum based systemic therapy. Participants will be randomised 2:1, stratified according to histology and response to prior platinum-based chemotherapy, to receive either active symptom control (ASC) and niraparib or ASC alone, for up to 24 weeks. Participants will be treated until disease progression, withdrawal, death or development of significant treatment limiting toxicity. Participants randomised to niraparib will receive 200 or 300 mg daily in a 3-weekly cycle. The primary endpoint is progression-free survival, where progression is determined by modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1; investigator reported progression; or death from any cause, whichever comes first. Secondary endpoints include overall survival, best overall response, 12-week and 24 week disease control, duration of response, treatment compliance and safety/tolerability. If NERO shows niraparib to be safe and biologically effective, it may lead to future late phase randomised controlled trials in relapsed mesothelioma.
The study received ethical approval from London-Hampstead Research Ethics Committee on 06-May-2022 (22/LO/0281). Data from all centres will be analysed together and published as soon as possible.
ISCRTN16171129; NCT05455424.
Headache is a common chief complaint of children presenting to emergency departments (EDs). Approximately 0.5%–1% will have emergent intracranial abnormalities (EIAs) such as brain tumours or strokes. However, more than one-third undergo emergent neuroimaging in the ED, resulting in a large number of children unnecessarily exposed to radiation. The overuse of neuroimaging in children with headaches in the ED is driven by clinician concern for life-threatening EIAs and lack of clarity regarding which clinical characteristics accurately identify children with EIAs. The study objective is to derive and internally validate a stratification model that accurately identifies the risk of EIA in children with headaches based on clinically sensible and reliable variables.
Prospective cohort study of 28 000 children with headaches presenting to any of 18 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). We include children aged 2–17 years with a chief complaint of headache. We exclude children with a clear non-intracranial alternative diagnosis, fever, neuroimaging within previous year, neurological or developmental condition such that patient history or physical examination may be unreliable, Glasgow Coma Scale score
Ethics approval was obtained for all participating sites from the University of Utah single Institutional Review Board. A waiver of informed consent was granted for collection of ED data. Verbal consent is obtained for follow-up contact. Results will be disseminated through international conferences, peer-reviewed publications, and open-access materials.
Background
Women veterans have a high prevalence of traditional and nontraditional risks for cardiovascular disease (CVD) including obesity and posttraumatic stress disorder. Experts from the U.S. Department of Veterans Affairs have called for actions to improve the cardiovascular health of this population. One approach is to assess women veterans’ barriers to care-seeking for CVD prevention, to inform future intervention research.
Objective
The objective of this study was to describe women veterans’ barriers to care-seeking for CVD prevention, guided by the theory of care-seeking behavior and concept awareness.
Methods
Using a cross-sectional, descriptive design, a national sample of 245 women veterans participated in an online survey about barriers to care-seeking. Participants provided narrative responses to open-ended items, endorsements to closed-ended items, and rankings of their top five barriers. Researchers conducted poststratification weighting of numerical data to reflect the women veteran population.
Results
Narrative responses described unaffordable and inaccessible services, feeling harassed or not respected in healthcare settings, and lack of awareness of risks for CVD. Frequently endorsed barriers were unaffordable and inaccessible services. Frequently ranked barriers were feeling not respected in healthcare settings and clinicians not recommending CVD prevention.
Discussion
Findings support concepts in theory of care-seeking behavior and concept awareness. Understanding women veterans’ barriers to care-seeking for CVD prevention can inform clinicians and researchers as they address these barriers. Poor interdisciplinary care team communication has been associated with increased mortality. The study aimed to define conditions for effective interdisciplinary care team communication.
An observational cross-sectional qualitative study.
A surgical intensive care unit in a large, urban, academic referral medical centre.
A total 6 interviews and 10 focus groups from February to June 2021 (N=33) were performed. Interdisciplinary clinicians who cared for critically ill patients were interviewed. Participants included intensivist, transplant, colorectal, vascular, surgical oncology, trauma faculty surgeons (n=10); emergency medicine, surgery, gynaecology, radiology physicians-in-training (n=6), advanced practice providers (n=5), nurses (n=7), fellows (n=1) and subspecialist clinicians such as respiratory therapists, pharmacists and dieticians (n=4). Audiorecorded content of interviews and focus groups were deidentified and transcribed verbatim. The study team iteratively generated the codebook. All transcripts were independently coded by two team members.
Conditions for effective interdisciplinary care team communication.
We identified five themes relating to conditions for effective interdisciplinary care team communication in our surgical intensive care unit setting: role definition, formal processes, informal communication pathways, hierarchical influences and psychological safety. Participants reported that clear role definition and standardised formal communication processes empowered clinicians to engage in discussions that mitigated hierarchy and facilitated psychological safety.
Standardising communication and creating defined roles in formal processes can promote effective interdisciplinary care team communication by fostering psychological safety.
Commentary on: Goeddel L, Murphy Z, Owodunni O, et al. Domains of Frailty Predict Loss of Independence in Older Adults after Non-Cardiac Surgery. Ann Surg. 2022 Sep 20. doi: 10.1097/SLA.0000000000005720. Epub ahead of print.
Frailty screening with the Edmonton Frailty Scale can be used to identify risk factors for loss of independence after surgery, including a patient’s functional performance, functional dependence, social support and urinary incontinence. Prospective studies are needed to test whether risk factors can be modified before surgery to prevent loss of independence among frail patients.
Frailty is a common syndrome of physiological decline among older adults characterised by vulnerability to adverse outcomes and loss of functional independence after major surgery.
Chronic kidney disease (CKD) is increasingly recognised as a growing global public health problem. Early detection and management can significantly reduce the loss of kidney function. The proposed trial aims to evaluate the impact of a community pharmacy-led intervention combining CKD screening and medication review on CKD detection and quality use of medicines (QUM) for patients with CKD. We hypothesise that the proposed intervention will enhance detection of newly diagnosed CKD cases and reduce potentially inappropriate medications use by people at risk of or living with CKD.
This study is a multicentre, pragmatic, two-level cluster randomised controlled trial which will be conducted across different regions in Australia. Clusters of community pharmacies from geographical groups of co-located postcodes will be randomised. The project will be conducted in 122 community pharmacies distributed across metropolitan and rural areas. The trial consists of two arms: (1) Control Group: a risk assessment using the QKidney CKD risk assessment tool, and (2) Intervention Group: a risk assessment using the QKidney CKD plus Point-of-Care Testing for kidney function markers (serum creatinine and estimated glomerular filtration rate), followed by a QUM service. The primary outcomes of the study are the proportion of patients newly diagnosed with CKD at the end of the study period (12 months); and rates of changes in the number of medications considered problematic in kidney disease (number of medications prescribed at inappropriate doses based on kidney function and/or number of nephrotoxic medications) over the same period. Secondary outcomes include proportion of people on potentially inappropriate medications, types of recommendations provided by the pharmacist (and acceptance rate by general practitioners), proportion of people who were screened, referred, and took up the referral to visit their general practitioners, and economic and other patient-centred outcomes.
The trial protocol has been approved by the Human Research Ethics Committee at the University of Sydney (2022/044) and the findings of the study will be presented at scientific conferences and published in peer-reviewed journal(s).
Australian New Zealand Clinical Trials Registry (ACTRN12622000329763).
In 2019, the WHO released guidelines on HIV testing service (HTS). We aim to assess the adoption of six of these recommendations on HIV testing strategies among African countries.
Policy review.
47 countries within the WHO African region.
National HTS policies from the WHO African region as of December 2021.
Primary and secondary outcome measures: Uptake of WHO recommendations across national HTS policies including the standard three-test strategy; discontinuation of a tiebreaker test to rule in HIV infection; discontinuation of western blotting (WB) for HIV diagnosis; retesting prior to antiretroviral treatment (ART) initiation and the use of dual HIV/syphilis rapid diagnostic tests (RDTs) in antenatal care. Country policy adoption was assessed on a continuum, based on varying levels of complete adoption.
National policies were reviewed for 96% (n=45/47) of countries in the WHO African region, 38% (n=18) were published before 2019 and 60% (n=28) adopted WHO guidance. Among countries that had not fully adopted WHO guidance, not yet adopting a three-test strategy was the most common reason for misalignment (45%, 21/47); of which 31% and 22% were in low-prevalence (
Many countries in the African region have adopted WHO-recommended HIV testing strategies; however, efforts are still needed to fully adopt WHO guidance. Countries should accelerate their efforts to adopt and implement a three-test strategy, retesting prior to ART initiation and the use of dual HIV/syphilis RDTs.
This paper aims to inform nursing and other healthcare disciplines by clearly defining patient competence and the skills required to improve self-care behaviours.
Competence has been defined in education and leadership. However, competence in persons with chronic disease has not been expanded upon since one publication in 1983. Patient competence needs to be developed and defined so that healthcare disciplines can understand the attributes necessary for a patient to be deemed competent to promote self-care behaviours.
A concept derivation.
Walker and Avant's approach to concept derivation was used to identify a base concept (competence) that is well-defined in another field, define the concepts associated with the parent field, and transpose that definition to a new field to formulate a redefined concept. PsycINFO, Scopus, Web of Science and Medline were searched, and 21 articles were included.
Patient competence is defined as the ability of a person with a chronic illness to reach skill mastery, achieve knowledge, maintain a positive attitude and develop trust in themselves and in healthcare providers that will facilitate active engagement to improve self-care behaviours.
Defining patient competence is important in assisting nurses and other healthcare providers in understanding the attributes needed to deem a patient competent, especially those living with chronic illnesses requiring lifelong self-care behaviours. More research is needed to aid in the designing of a precise instrument for measuring this phenomenon.
Concept derivation of patient competence provides a framework for nurses and other members of the healthcare profession to understand the attributes needed to determine patient competence.
This study aimed to evaluate the prospective cost-effectiveness of the Identification and Referral to Improve Safety plus (IRIS+) intervention compared with usual care using feasibility data derived from seven UK general practice sites.
A cost–utility analysis was conducted to assess the potential cost-effectiveness of IRIS+, an enhanced model of the UK’s usual care. IRIS+ assisted primary care staff in identifying, documenting and referring not only women, but also men and children who may have experienced domestic violence/abuse as victims, perpetrators or both. A perpetrator group programme was not part of the intervention per se but was linked to the IRIS+ intervention via a referral pathway and signposting. A Markov model was constructed from a societal perspective to estimate mean incremental costs and quality-adjusted life years (QALYs) of IRIS+ compared with to usual care over a 10-year time horizon.
The IRIS+ intervention saved £92 per patient and produced QALY gains of 0.003. The incremental net monetary benefit was positive (£145) and the IRIS+ intervention was cost-effective in 55% of simulations at a cost-effectiveness threshold of £20 000 per QALY.
The IRIS+ intervention could be cost-effective or even cost saving from a societal perspective in the UK, though there are large uncertainties, reflected in the confidence intervals and simulation results.
This study offers an empirical exploration of self-assessed digital competencies of students, most of whom studied in nursing courses, using a discipline-based self-assessment survey tool. A range of digital competencies were explored: information and communication technology proficiency and productivity, information literacy, digital creation, digital research, digital communication, digital learning and development, digital innovation, digital identity management and digital well-being.
A cross-sectional empirical study.
Quantitative data were collected from November to December 2021 via a questionnaire survey administered to students. Quantitative results were reported through descriptive statistical analysis. Mann–Whitney (U-test) and Kruskal–Wallis non-parametric statistical tests were used to identify statistically significant differences based on age demographics and pre- or post-registration course. Thematic analysis was utilized for survey open-ended questions data.
Students reported low competencies in the following digital literacy dimensions, all of which were imperative for their studies and for their future professional careers: information literacy, digital research, digital innovation. Significant statistical subgroup differences were found between age demographics and pre/post-registration within most of the digital competence dimensions. The survey open-ended comments revealed that students encountered challenges around digital skills they had mostly developed via everyday life experiences and trial-and-error approaches.
Increasing awareness of existing digital gaps and offering tailored digital skills enhancement can empower students as future-proof evidence-based practitioners in an evolving digital healthcare landscape.
Highlights the importance of embedding digital literacy within nursing study programmes, as preparation for comprehensive patient healthcare.
Offers insights into digital competencies gaps of nursing students. Proposes targeted educational digital skills training interventions. Stresses the value of academic staff supporting nursing students to develop digital skills in important areas of professional practice.
JBI critical appraisal checklist.
No patient or public contribution.
To identify how family caregivers adapt to the caregiving role following a relative's COVID-19-related intensive care unit (ICU) hospitalisation.
Family caregiving is often associated with poor health amongst caregivers which may limit their capacity to effectively support patients. Though severe COVID-19 infection has necessitated increasing numbers of persons who require caregiver support, little is known about these caregivers, the persons they are caring for, or the strategies used to effectively adjust to the caregiving role.
A qualitative descriptive study design was adopted, and findings are reported using COREQ.
A secondary analysis of transcripts from semi-structured interviews conducted with recently discharged ICU patients who had COVID-19 (n = 16) and their family caregivers (n = 16) was completed using thematic analysis. MAXQDA 2020 and Miro were used to organise data and complete coding. Analysis involved a structured process of open and closed coding to identify and confirm themes that elucidated adaptation to family caregiving.
Six themes highlight how family caregivers adapt to the caregiving role following an ICU COVID-19-related hospitalisation including (1) engaging the support of family and friends, (2) increased responsibilities to accommodate caregiving, (3) managing emotions, (4) managing infection control, (5) addressing patient independence and (6) engaging support services. These themes were found to be congruent with the Roy adaptation model.
Family caregiving is a stressful transition following a patient's acute hospitalisation. Effective adaptation requires flexibility and sufficient support, beginning with the care team who can adequately prepare the family for the anticipated challenges of recovery.
Clinical teams may improve post-hospitalisation care outcomes of patients by preparing families to effectively adjust to the caregiver role—particularly in identifying sufficient support resources.
Participation of patients/caregivers in this study was limited to the data provided through participant interviews.
Employee Occupational Health (‘occupational health’) clinicians have expansive perspectives of the experience of healthcare personnel. Integrating mental health into the purview of occupational health is a newer approach that could combat historical limitations of healthcare personnel mental health programmes, which have been isolated and underused.
We aimed to document innovation and opportunities for supporting healthcare personnel mental health through occupational health clinicians. This work was part of a national qualitative needs assessment of employee occupational health clinicians during COVID-19 who were very much at the centre of organisational responses.
This qualitative needs assessment included key informant interviews obtained using snowball sampling methods.
We interviewed 43 US Veterans Health Administration occupational health clinicians from 29 facilities.
This analysis focused on personnel mental health needs and opportunities, using consensus coding of interview transcripts and modified member checking.
Three major opportunities to support mental health through occupational health involved: (1) expanded mental health needs of healthcare personnel, including opportunities to support work-related concerns (eg, traumatic deployments), home-based concerns and bereavement (eg, working with chaplains); (2) leveraging expanded roles and protocols to address healthcare personnel mental health concerns, including opportunities in expanding occupational health roles, cross-disciplinary partnerships (eg, with employee assistance programmes (EAP)) and process/protocol (eg, acute suicidal ideation pathways) and (3) need for supporting occupational health clinicians’ own mental health, including opportunities to address overwork/burn-out with adequate staffing/resources.
Occupational health can enact strategies to support personnel mental health: to structurally sustain attention, use social cognition tools (eg, suicidality protocols or expanded job descriptions); to leverage distributed attention, enhance interdisciplinary collaboration (eg, chaplains for bereavement support or EAP) and to equip systems with resources and allow for flexibility during crises, including increased staffing.
Uterine fibroids affect 30%–77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG’s efficacy in treating women with fibroids and unexplained infertility.
This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores.
The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial.
The National Congenital Anomaly and Rare Disease Registration Service (NCARDRS), part of National Disease Registration Service in National Health Service England, quality assures, curates and analyses individual data on the pregnancies, fetuses, babies, children and adults with congenital anomalies and rare diseases across England. The congenital anomaly (CA) register provides a resource for patients and their families, clinicians, researchers and public health professionals in furthering the understanding of CAs.
NCARDRS registers CAs occurring in babies born alive and stillborn, fetal losses and terminations in England. NCARDRS collects data from secondary and tertiary healthcare providers, private providers and laboratories covering fetal medicine, maternity or paediatric services. Data describe the pregnancy, mother, baby and anomaly. Established in 2015, NCARDRS expanded CA registration coverage from 22% of total births in England in 2015 to national coverage, which was achieved in 2018. Prior to 2015, data collection was performed independently by regional registers in England; these data are also held by NCARDRS.
NCARDRS registers approximately 21 000 babies with CAs per year with surveillance covering around 600 000 total births, the largest birth coverage for a CA register globally. Data on prevalence, risk factors and survival for children with CAs are available. Data have been used in several peer-reviewed publications. Birth prevalence statistics, including public health indicators such as the association with maternal age, infant and perinatal mortality, are published annually. NCARDRS supports clinical audit for screening programmes and service evaluation.
NCARDRS provides a valuable resource for the understanding of the epidemiology, surveillance, prevention and treatment of CAs. Currently, approximately 21 000 new registrations of babies or fetuses with suspected or confirmed CAs are added each year. Identifiers are collected, enabling linkage to routinely collected healthcare and population statistics, further enhancing the value of the data.
Knowledge models inform organizational behavior through the logical association of documentation processes, definitions, data elements, and value sets. The development of a well-designed knowledge model allows for the reuse of electronic health record data to promote efficiency in practice, data interoperability, and the extensibility of data to new capabilities or functionality such as clinical decision support, quality improvement, and research. The purpose of this article is to describe the development and validation of a knowledge model for healthcare-associated venous thromboembolism prevention. The team used FloMap, an Internet-based survey resource, to compare metadata from six healthcare organizations to an initial draft model. The team used consensus decision-making over time to compare survey results. The resulting model included seven panels, 41 questions, and 231 values. A second validation step included completion of an Internet-based survey with 26 staff nurse respondents representing 15 healthcare organizations, two electronic health record vendors, and one academic institution. The final knowledge model contained nine Logical Observation Identifiers Names and Codes panels, 32 concepts, and 195 values representing an additional six panels (groupings), 15 concepts (questions), and the specification of 195 values (answers). The final model is useful for consistent documentation to demonstrate the contribution of nursing practice to the prevention of venous thromboembolism. Group B streptococcus (GBS), or Streptococcus agalactiae, remains a leading cause of neonatal morbidity and mortality. Canadian guidelines advise universal maternal screening for GBS colonisation in pregnancy in conjunction with selective antibiotic therapy. This results in over 1000 pregnant individuals receiving antibiotic therapy to prevent one case of early-onset neonatal GBS disease, and over 20 000 pregnant individuals receiving antibiotic therapy to prevent one neonatal death. Given the growing concern regarding the risk of negative sequela from antibiotic exposure, it is vital that alternative approaches to reduce maternal GBS colonisation are explored.
Preliminary studies suggest some probiotic strains could confer protection in pregnancy against GBS colonisation.
This double-blind parallel group randomised trial aims to recruit 450 pregnant participants in Vancouver, BC, Canada and will compare GBS colonisation rates in those who have received a daily oral dose of three strains of probiotics with those who have received a placebo. The primary outcome will be GBS colonisation status, measured using a vaginal/rectal swab obtained between 35 weeks’ gestation and delivery. Secondary outcomes will include maternal antibiotic exposure and urogenital infections. Analysis will be on an intention-to-treat basis.
There was no patient or public involvement in the design of the study protocol.
This study protocol received ethics approval from the University of British Columbia’s Clinical Research Ethics Board, Dublin City University and Health Canada. Findings will be presented at research rounds, conferences and in peer-reviewed publications.
Management controversy and clinical equipoise exist in treatments of long bone fractures and traumatic hip dislocation in paediatric patients due to the lack of high-quality clinical evidence. This protocol describes the effort of a large prospective global multicentre cohort study (registry) aiming at providing quality data to assist evidence-based treatment decision-making.
Eligible paediatric patients (N=750–1000) with open physes suffering from proximal humerus fractures, distal humerus fractures, proximal radius fractures, forearm shaft fractures, traumatic hip dislocations, femoral neck fractures or tibial shaft fractures will be recruited over a period of 24–36 months. Hospitalisation and treatment details (including materials and implants) will be captured in a cloud-based, searchable database. Outcome measures include radiographic assessments, clinical outcomes (such as range of motion, limb length discrepancies and implant removal), patient-reported outcomes (Patient Reported Outcomes Of Fracture, Patient-Reported Outcomes Measurement Information System (PROMIS) and EuroQol-5D (EQ-5D-Y)) and adverse events.
Aside from descriptive statistics on patient demographics, baseline characteristics, types of fractures and adverse event rates, research questions will be formulated based on data availability and quality. A statistical analysis plan will be prepared before the statistical analysis.
Ethics approval will be obtained before patients are enrolled at each participating site. Patient enrolment will follow an informed consent process approved by the responsible ethics committee. Peer-reviewed publication is planned to disseminate the study results.
FreshRSS 