Conectar
To test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement.
Feasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study.
Two National Health Service (NHS) secondary care hospitals in England and Wales.
Preoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0–28 on the Sleep Condition Indicator questionnaire.
The REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals.
The primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients.
Screening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable.
This feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible.
Co-creation approaches, such as co-design and co-production, aspire to power-sharing and collaboration between service providers and service users, recognising the specific insights each group can provide to improve health and other public services. However, an intentional focus on equity-based approaches grounded in lived experience and epistemic justice is required considering entrenched structural inequities between service-users and service-providers in public and institutional spaces where co-creation happens.
This paper presents a Charter of tenets and principles to foster a new era of ‘Equity-based Co-Creation’ (EqCC).
The Charter is based on themes heard during an International Forum held in August 2022 in Ontario, Canada, where 48 lived experience experts and researchers were purposively invited to deliberate challenges and opportunities in advancing equity in the co-creation field.
The Charter’s seven tenets—honouring worldviews, acknowledging ongoing and historical harms, operationalising inclusivity, establishing safer and brave spaces, valuing lived experiences, ‘being with’ and fostering trust, and cultivating an EqCC heartset/mindset—aim to promote intentional inclusion of participants with intersecting social positions and differing historic oppressions. This means honouring and foregrounding lived experiences of service users and communities experiencing ongoing structural oppression and socio-political alienation—Black, Indigenous and people of colour; disabled, Mad and Deaf communities, women, 2S/LGBTQIA+ communities, people perceived to be mentally ill and other minoritised groups—to address epistemic injustice in co-creation methodologies and practice, thereby providing opportunities to begin to dismantle intersecting systems of oppression and structural violence.
Each Charter tenet speaks to a multilayered, multidimensional process that is foundational to shifting paradigms about redesigning our health and social systems and changing our relational practices. Readers are encouraged to share their reactions to the Charter, their experiences implementing it in their own work, and to participate in a growing international EqCC community of practice.
Adolescents face challenges associated with unprecedented environmental, social and technological changes. The impacts of colonisation, intergenerational trauma, racism and socioeconomic disadvantage intensify these challenges for many Aboriginal and Torres Strait Islander adolescents. However, Aboriginal and Torres Strait Islander adolescents also have cultural, spiritual, family and community capital that fosters their well-being.
To date, little research has focused on understanding and appropriately measuring the well-being of Aboriginal and Torres Strait Islander adolescents, a pivotal factor in informing and guiding programmes and interventions that support them. This study will identify the domains of well-being and develop a new preference-based well-being measure based on the values and preferences of Aboriginal and Torres Strait Islander youth (aged 12–17 years).
This project will be conducted across three research phases: (1) qualitative exploration of well-being using PhotoYarning and yarns with adult mentors to develop candidate items; (2) Think Aloud study, quantitative survey, psychometric analysis, validity testing of candidate items and finalisation of the descriptive system; and (3) scoring development using a quantitative preference-based approach. A multinomial (conditional) logit framework will be used to analyse responses and generate a scoring algorithm for the new preference-based well-being measure.
Ethics approvals have been obtained from: the Human Research Ethics Committees for each state and territory where data are being collected, the institutions where the research is being conducted and from the relevant Departments of Education. The new well-being measure will have wide applicability and can be used in assessing the effectiveness of programmes and services. This new national measure will ensure benefit and positive impact through the ability to identify and measure the aspects of well-being important to and valued by Aboriginal and Torres Strait Islander youth. Results will be published in international peer-reviewed journals and presented at conferences, and summaries will be provided to the study partner organisations and other relevant organisations.
Young people aged 18–24 years old are a key demographic target for eliminating HIV transmission globally. Pre-exposure prophylaxis (PrEP), a prevention medication, reduces HIV transmission. Despite good uptake by gay and bisexual men who have sex with men, hesitancy to use PrEP has been observed in other groups, such as young people and people from ethnic minority backgrounds. The aim of this study was to explore young people’s perceptions and attitudes to using PrEP.
A qualitative transcendental phenomenological design was used.
A convenience sample of 24 young people aged between 18 and 24 years was recruited from England.
Semistructured interviews and graphical elicitation were used to collect data including questions about current experiences of HIV care, awareness of using PrEP and decision-making about accessing PrEP. Thematic and visual analyses were used to identify findings.
Young people had good levels of knowledge about HIV but poor understanding of using PrEP. In this information vacuum, negative stigma and stereotypes about HIV and homosexuality were transferred to using PrEP, which were reinforced by cultural norms portrayed on social media, television and film—such as an association between using PrEP and being a promiscuous, white, gay male. In addition, young people from ethnic minority communities appeared to have negative attitudes to PrEP use, compared with ethnic majority counterparts. This meant these young people in our study were unable to make decisions about when and how to use PrEP.
Findings indicate an information vacuum for young people regarding PrEP. A strength of the study is that theoretical data saturation was reached. A limitation of the study is participants were largely from Northern England, which has low prevalence of HIV. Further work is required to explore the information needs of young people in relation to PrEP.
BioMD-Y is a comprehensive biobank study of children and adolescents with major depression (MD) and their healthy peers in Germany, collecting a host of both biological and psychosocial information from the participants and their parents with the aim of exploring genetic and environmental risk and protective factors for MD in children and adolescents.
Children and adolescents aged 8–18 years are recruited to either the clinical case group (MD, diagnosis of MD disorder) or the typically developing control group (absence of any psychiatric condition).
To date, four publications on both genetic and environmental risk and resilience factors (including FKBP5, glucocorticoid receptor activation, polygenic risk scores, psychosocial and sociodemographic risk and resilience factors) have been published based on the BioMD-Y sample.
Data collection is currently scheduled to continue into 2026. Research questions will be further addressed using available measures.
A trauma-informed approach (TIA) means working with awareness that people’s histories of trauma may shape the way they engage with services, organisations or institutions. Young people with adverse childhood experiences may be at risk of retraumatisation by organisational practices in schools and universities and by employers and health agencies when they seek support. There are limited evidence-based resources to help people working in the public sector to work with adolescents in trauma-informed ways and the needs of adolescents have not been central in resource development. This study contributes to public sector capacity to work in trauma-informed ways with adolescents by codesigning and evaluating the implementation of a youth-informed organisational resource.
This is an Accelerated Experience-based Co-design (AEBCD) Study followed by pre–post evaluation. Public sector organisations or services, and adolescents connected with them, will collaboratively reflect on lived experience data assembled through creative arts practice, alongside data from epidemiological national data sets. These will present knowledge about the impact of adverse childhood experiences on adolescents’ mental health (stage 1). Collaboratively, priorities (touch points) for organisational responses will be identified (stage 2), and a low-burden resource will be codesigned (stage 3) and offered for implementation (stage 4) and evaluation (stage 5) in diverse settings. The study will provide insights into what adolescents and public sector organisations in the UK want from a TIA resource, the experience of services/organisations in implementing this and recommendations for resource development and implementation.
The UK National Health Service Health Research Authority approved this study (23/WM/0105). Learning will be shared across study participants in a workshop at the end of the study. Knowledge products will include a website detailing the created resource and a youth-created film documenting the study process, the elements of the codesigned resource and experiences of implementation. Dissemination will target academic, healthcare, education, social care, third sector and local government settings via knowledge exchange events, social media, accessible briefings, conference presentations and publications.
Glaucoma is the leading cause of irreversible blindness in the world. The need to diagnose glaucoma early in its natural history before extensive sight loss occurs cannot be overemphasised. However, glaucoma is largely asymptomatic in the early stages of the disease making it complex to diagnose clinically and requires the support of technology. The objective of this scoping review is to determine the nature and extent of the evidence for use of portable devices in the diagnosis of glaucoma.
We will consider studies conducted in all healthcare settings using portable devices for the detection of all type of adult glaucoma. We will also include any systematic reviews or scoping reviews, which relate to this topic. Searches will be conducted in MEDLINE, Embase, CENTRAL on the Cochrane Library and Global Health databases, from their inception to the present. Reference lists from publications identified in the searches will also be reviewed. Two authors will independently screen titles and abstracts, followed by full-text screening to assess studies for inclusion. Any disagreements will be discussed and resolved with a third author. Tables accompanied by narrative descriptions will be employed to discuss results and show how it relates to review questions.
Ethical approval is not required in this review. Only published and publicly accessible data will be used. We will publish our findings in an open-access, peer-reviewed journal and develop an accessible summary of results and recommendations.
To evaluate the quality and analyse the content of clinical practice guidelines regarding central venous catheter-related thrombosis (CRT) to provide evidence for formulating an evidence-based practice protocol and a risk assessment scale to prevent it.
Scoring and analysis of the guidelines using the AGREE II and AGREE REX scales.
Pubmed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and the Chinese Biomedical Literature, and the relevant websites of the guideline, were searched from 1 January 2017 to 26 March 2022.
Guidelines covering CRT treatment, prevention, or management were included from 1 January 2017 to 26 March 2022.
Three independent reviewers systematically trained in using the AGREE II and AGREE REX scales were selected to evaluate these guidelines.
Nine guidelines were included, and the quality grade results showed that three were at A-level and six were at B-level. The included guidelines mainly recommended the prevention measure of central venous CRT from three aspects: risk screening, prevention strategies, and knowledge training, with a total of 22 suggestions being recommended.
The overall quality of the guidelines is high, but there are few preventive measures for central venous CRT involved in the guidelines. All preventive measures have yet to be systematically integrated and evaluated, and no risk assessment scale dedicated to this field has been recommended. Therefore, developing an evidence-based practice protocol and a risk assessment scale to prevent it is urgent.
To investigate evidence-based practices and examine the influence of individual and social system factors on evidence-based practices among nurses in general hospitals.
Evidence-based practice is essential for improving healthcare quality. However, a challenge for nursing worldwide is nurses' limited use of evidence-based practices. It is crucial to determine the individual and social system factors affecting nurses' use of evidence-based practices.
This study employs a multi-institutional cross-sectional design.
With a multistage random sampling method, 336 registered nurses were recruited from 17 general hospitals in the Republic of the Union of Myanmar. Data were collected through a seven-part questionnaire, including the Evidence-Based Practice Implementation Scale and individual and social system factors. Data were analyzed using descriptive statistics and multiple linear regression.
Nurses in general hospitals perceived low levels of evidence-based practices. Individual factors, such as perceived barriers (p < .001), knowledge (p < .001) and attitudes (p = .001), were related to EBP as well as social system factors, including the work environment (p < .001) which influence nurses' practice, explaining 34% variance among nurses.
Nurses perceived the work environment as the most influencing factor related to evidence-based practices. Individual characteristics, including perceived knowledge, attitudes and barriers, were critical factors in performing evidence-based practices in Myanmar.
Nurse administrators and policymakers can develop strategies and interventions for improving knowledge, attitudes and work environment towards evidence-based practice. Minimizing the barriers to evidence-based practice will promote evidence-based practices in Myanmar general hospitals.
In addressing the individual and social system factors influencing the evidence-based practices of nurses, this study contributes to enhancing healthcare quality and outcomes.
This study adhered to the STROBE checklist.
There was no patient or public contribution.
To determine patients', nurses' and researchers' opinions on the appropriateness and completeness of the proposed conceptualization of nurses' support of hospitalised patients' self-management.
A modified Delphi study.
We conducted a two-round Delphi survey. The panel group consisted of patients, nurses and researchers. The conceptualization of nurses' support of hospitalised patients' self-management presented in the first Delphi round was based on previous research, including a scoping review of the literature. Data was analysed between both rounds and after the second round. Results are reported in accordance with the guidance on Conducting and Reporting Delphi Studies (CREDES).
In the first round all activities of the proposed conceptualization were considered appropriate to support the patients' self-management. Panel members' comments led to the textual adjustment of 19 activities, the development of 15 new activities, and three general questions related to self-management support during hospitalisation. In the second round the modified and the newly added activities were also deemed appropriate. The clarification statements raised in the first Delphi round were accepted, although questions remained about the wording of the activities and about what is and what is not self-management support.
After textual adjustments and the addition of some activities, the proposed conceptualization of nurses' support in patients' self-management while hospitalised have been considered appropriate and complete. Nevertheless, questions about the scope of this concept still remains. The results provide a starting point for further discussion and the development of self-management programs aimed at the hospitalised patient.
The results can be considered as a starting point for practice to discuss the concept of nurses' support for hospitalised patients' self-management and develop, implement and research self-management programs specific for their patient population.
Results are reported in accordance with the guidance on Conducting and Reporting Delphi Studies (CREDES).
Patients were involved as expert panellist in this Delphi study.
Self-management support during hospitalisation is understudied, which undermines the development of evidence-based interventions.
A panel, consisting of patients, nurses and researchers, agreed on the appropriateness of a conceptualization of nurses' support of inpatients' self-management, and identified some points for discussion, mainly related to the boundaries of the concept self-management.
This study is crucial for generating conceptual understanding of how nurses support patients' self-management during hospitalisation. This is necessary for policy, clinical practice, education, and research on this topic.
To determine the association between nurse and institutional characteristics and perceived professional nurse knowledge and self-efficacy of reporting child abuse and neglect.
A sample of N = 166 nurses were recruited to respond to the Reporting of Suspected Child Abuse and Neglect (RSCAN) survey.
A multiple linear regression examined whether nurse characteristics and institutional characteristics were associated with the two RSCAN survey domain scores.
Perceived knowledge of a workplace child abuse and neglect protocol was associated with the knowledge subscale. Education and child abuse and neglect expertise were significant predictors of the self-efficacy subscale. Nurses with a master's or higher degree and those who identified as being either forensic, paediatric or Emergency Department nurses, had less perceived institutional barriers to self-efficacy of reporting child abuse and neglect.
This study provides a preliminary insight into the institutional barriers and facilitators of nurses as child abuse and neglect mandated reporters.
To encourage innovative education and collaborations to support nurses as fully informed child abuse and neglect mandated reporters.
This research identifies the gaps and facilitators of nurses as child abuse and neglect mandated reporters to inform healthcare professionals and academic institutions on the importance of nurse education and experience in nurse knowledge and self-efficacy in reporting suspected child abuse and neglect.
The authors of this study have adhered to relevant EQUATOR guidelines: STROBE.
There is no patient or public contribution as the study only looked at nurses.
To develop and internally validate risk prediction models for subsequent clinical deterioration, unplanned ICU admission and death among ward patients following medical emergency team (MET) review.
A retrospective cohort study of 1500 patients who remained on a general ward following MET review at an Australian quaternary hospital.
Logistic regression was used to model (1) subsequent MET review within 48 h, (2) unplanned ICU admission within 48 h and (3) hospital mortality. Models included demographic, clinical and illness severity variables. Model performance was evaluated using discrimination and calibration with optimism-corrected bootstrapped estimates. Findings are reported using the TRIPOD guideline for multivariable prediction models for prognosis or diagnosis. There was no patient or public involvement in the development and conduct of this study.
Within 48 h of index MET review, 8.3% (n = 125) of patients had a subsequent MET review, 7.2% (n = 108) had an unplanned ICU admission and in-hospital mortality was 16% (n = 240). From clinically preselected predictors, models retained age, sex, comorbidity, resuscitation limitation, acuity-dependency profile, MET activation triggers and whether the patient was within 24 h of hospital admission, ICU discharge or surgery. Models for subsequent MET review, unplanned ICU admission, and death had adequate accuracy in development and bootstrapped validation samples.
Patients requiring MET review demonstrate complex clinical characteristics and the majority remain on the ward after review for deterioration. A risk score could be used to identify patients at risk of poor outcomes after MET review and support general ward clinical decision-making.
Our risk calculator estimates risk for patient outcomes following MET review using clinical data available at the bedside. Future validation and implementation could support evidence-informed team communication and patient placement decisions.
To gain a greater understanding of how compression therapy affects quality of life, this systematic review appraised existing published studies measuring the impact of compression therapy on health quality of life (HRQoL), and pain, among people with venous leg ulcers (VLU).
Five databases were searched, and two authors extracted data and appraised the quality of selected papers using the RevMan risk of bias tool. Due to heterogeneity in the types of compression and instruments used to evaluate HRQoL, meta-analysis was not appropriate; thus, a narrative synthesis of findings was undertaken.
Ten studies were included, 9 RCTs and one before-after study. The studies employed nine different HRQoL tools to measure the impact of a variety of compression therapy systems, with or without an additional exercise programme, versus other compression systems or usual care, and the results are mixed. With the use of the Cardiff Cardiff Wound Impact Schedule, the SF-8 and the SF-12, study authors found no differences in QoL scores between the study groups. This is similar to one study using QUALYs (Iglesias et al., 2004). Conversely, for studies using EuroQol-5D, VEINES-QOL, SF-36 and CIVIQ-20 differences in QoL scores between the study groups were noted, in favour of the study intervention groups. Two further studies using QUALYs found results that favoured a two-layer cohesive compression bandage and the TLCCB group, respectively. Results for the five studies that assessed pain are also mixed, with one study finding no difference between study groups, one finding that pain increased over the study period and three studies finding that pain reduced in the intervention groups. All studies were assessed as being at risk of bias in one or more domains.
Results were varied, reflecting uncertainty in determining the impact of compression therapy on quality of life and pain among people with a venous leg ulcer. The heterogeneity of the compression systems and the measures used to evaluate HRQoL make it a challenge to interpret the overall evidence. Further studies should strive for homogeneity in design, interventions and comparators to enhance both internal and external validity.
The correlation between sub-epidermal moisture (SEM) and other early indicators of pressure ulcer (PU) development is yet to be determined. This three-part series aims to bridge this knowledge gap, through investigating SEM and its correlation with evidence-based technologies and assessments. This article focuses on the correlation between SEM and ultrasound. A prospective cohort observational study was undertaken between February and November 2021. Patients undergoing three surgery types were consecutively enrolled to the study following informed consent. Assessments were performed prior to and following surgery for 3 days at the sacrum, both heels and a control site, using a SEM scanner and high-frequency ultrasound scanner (5–15 MHz). Spearman's rank (r s ) explored the correlation between SEM and ultrasound. A total of 60 participants were included; 50% were male with a mean age of 58 years (±13.46). A statistically significant low to moderately positive correlation was observed between SEM and ultrasound across all anatomical sites (r s range = 0.39–0.54, p < 0.05). The only exception was a correlation between SEM and ultrasound on day 0 at the right heel (r s = 0.23, p = 0.09). These results indicate that SEM and ultrasound agreed in the presence of injury; however, SEM was able to identify abnormalities before ultrasound.
Loss of blood-brain barrier (BBB) integrity is hypothesised to be one of the earliest microvascular signs of Alzheimer’s disease (AD). Existing BBB integrity imaging methods involve contrast agents or ionising radiation, and pose limitations in terms of cost and logistics. Arterial spin labelling (ASL) perfusion MRI has been recently adapted to map the BBB permeability non-invasively. The DEveloping BBB-ASL as a non-Invasive Early biomarker (DEBBIE) consortium aims to develop this modified ASL-MRI technique for patient-specific and robust BBB permeability assessments. This article outlines the study design of the DEBBIE cohorts focused on investigating the potential of BBB-ASL as an early biomarker for AD (DEBBIE-AD).
DEBBIE-AD consists of a multicohort study enrolling participants with subjective cognitive decline, mild cognitive impairment and AD, as well as age-matched healthy controls, from 13 cohorts. The precision and accuracy of BBB-ASL will be evaluated in healthy participants. The clinical value of BBB-ASL will be evaluated by comparing results with both established and novel AD biomarkers. The DEBBIE-AD study aims to provide evidence of the ability of BBB-ASL to measure BBB permeability and demonstrate its utility in AD and AD-related pathologies.
Ethics approval was obtained for 10 cohorts, and is pending for 3 cohorts. The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.
Task-shifting from primary care physicians (PCPs) to nurses is one option to better and more efficiently meet the needs of the population in primary care and to overcome PCP shortages. This protocol outlines an overview of systematic reviews to assess the effects of delegation or substitution by nurses of PCPs’ activities regarding clinical, patient-relevant, professional and health services-related outcomes.
We will conduct a systematic literature search for secondary literature in PubMed/MEDLINE, EMBASE, CINAHL and Cochrane databases. Systematic reviews, meta-analyses and Health Technology Assessments in German and English comprising randomised controlled trials and prospective controlled trials will be considered for inclusion. Search terms will include Medical Subject Headings combined with free text words. At least one-third of abstracts and full-text articles are reviewed by two independent reviewers. Methodological quality will be assessed using the Overview Quality Assessment Questionnaire. We will only consider reviews if they include controlled trials, if the profession that substituted or delegated tasks was a nurse, if the profession of the control was a PCP, if the assessed intervention was the same in the intervention and control group and if the Overview Quality Assessment Questionnaire score is ≥5. The corrected covered area will be calculated to describe the degree of overlap of studies in the reviews included in the study. We will report the overview according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
The overview of secondary literature does not require the approval of an Ethics Committee and will be published in a peer-reviewed journal.
CRD42020183327.
Enhancing interprofessional education (IPE) fosters collaborative efforts among healthcare professionals specializing in musculoskeletal (MSK) care. This approach presents a valuable opportunity to address the pressing MSK disease burden in developing countries, with high prevalence rates and limited resources. While an abundance of literature on the various elements of IPE among healthcare students and professionals exists, shared contexts of practice of South African MSK disciplines are not currently developed through IPE at higher education level, establishing a need for South African formalised curricular IPE interventions with an explicit focus on undergraduate students of MSK healthcare professions.
The intended scoping review protocol is guided by the framework set out by Arksey and O’Malley, where the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews will guide the process of reporting. English sources (qualitative and quantitative methodological studies, conference papers and proceedings, systematic reviews, grey literature, unpublished materials, theses and dissertations) from the electronic databases PubMed, Scopus, ERIC and ProQuest with no date restriction will be included. A researcher, an independent reviewer and research librarian will search and extract data from abstracts and full texts for this scoping review, where any arising disagreements will be resolved by discussion. Reference lists of relevant literature will be scrutinised. Relevant literature will be recorded on a referencing software and deduplicated. The data collection will take place between May and October 2023. The findings will be reported narratively with the use of tables.
This scoping review does not require ethical approval as all literature used already exists in the public domain with no involvement of human participants. The findings from this planned review will be submitted to peer-reviewed journals and will be presented at higher education conferences. This scoping review protocol was registered on Open Science Framework with the registration osf.io/c27n4.
Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose–response nature of any identified association, to inform future hypertension management.
The study will use data from 2 of Australia’s largest cohort studies; the Australian Longitudinal Study on Women’s Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004–2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used.
Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings.
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.
Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.
BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.
BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.
FreshRSS 