Conectar
Characterised by chronic inflammation of the gastrointestinal tract, inflammatory bowel disease (IBD) symptoms including diarrhoea, abdominal pain and fatigue can significantly impact patient’s quality of life. Therapeutic developments in the last 20 years have revolutionised treatment. However, clinical trials and real-world data show primary non-response rates up to 40%. A significant challenge is an inability to predict which treatment will benefit individual patients.
Current understanding of IBD pathogenesis implicates complex interactions between host genetics and the gut microbiome. Most cohorts studying the gut microbiota to date have been underpowered, examined single treatments and produced heterogeneous results. Lack of cross-treatment comparisons and well-powered independent replication cohorts hampers the ability to infer real-world utility of predictive signatures.
IBD-RESPONSE will use multi-omic data to create a predictive tool for treatment response. Future patient benefit may include development of biomarker-based treatment stratification or manipulation of intestinal microbial targets. IBD-RESPONSE and downstream studies have the potential to improve quality of life, reduce patient risk and reduce expenditure on ineffective treatments.
This prospective, multicentre, observational study will identify and validate a predictive model for response to advanced IBD therapies, incorporating gut microbiome, metabolome, single-cell transcriptome, human genome, dietary and clinical data. 1325 participants commencing advanced therapies will be recruited from ~40 UK sites. Data will be collected at baseline, week 14 and week 54. The primary outcome is week 14 clinical response. Secondary outcomes include clinical remission, loss of response in week 14 responders, corticosteroid-free response/remission, time to treatment escalation and change in patient-reported outcome measures.
Ethical approval was obtained from the Wales Research Ethics Committee 5 (ref: 21/WA/0228). Recruitment is ongoing. Following study completion, results will be submitted for publication in peer-reviewed journals and presented at scientific meetings. Publications will be summarised at www.ibd-response.co.uk.
Menstrual health is essential for gender equity and the well-being of women and girls. Qualitative research has described the burden of poor menstrual health on health and education; however, these impacts have not been quantified, curtailing investment. The Adolescent Menstrual Experiences and Health Cohort (AMEHC) Study aims to describe menstrual health and its trajectories across adolescence, and quantify the relationships between menstrual health and girls’ health and education in Khulna, Bangladesh.
AMEHC is a prospective longitudinal cohort of 2016 adolescent girls recruited at the commencement of class 6 (secondary school, mean age=12) across 101 schools selected through a proportional random sampling approach. Each year, the cohort will be asked to complete a survey capturing (1) girls’ menstrual health and experiences, (2) support for menstrual health, and (3) health and education outcomes. Survey questions were refined through qualitative research, cognitive interviews and pilot survey in the year preceding the cohort. Girls’ guardians will be surveyed at baseline and wave 2 to capture their perspectives and household demographics. Annual assessments will capture schools’ water, sanitation and hygiene, and support for menstruation and collect data on participants’ education, including school attendance and performance (in maths, literacy). Cohort enrolment and baseline survey commenced in February 2023. Follow-up waves are scheduled for 2024, 2025 and 2026, with plans for extension. A nested subcohort will follow 406 post-menarche girls at 2-month intervals throughout 2023 (May, August, October) to describe changes across menstrual periods. This protocol outlines a priori hypotheses regarding the impacts of menstrual health to be tested through the cohort.
AMEHC has ethical approval from the Alfred Hospital Ethics Committee (369/22) and BRAC James P Grant School of Public Health Institutional Review Board (IRB-06 July 22-024). Study materials and outputs will be available open access through peer-reviewed publication and study web pages.
To explore youth, caregiver and staff perspectives on their vision of trauma-informed care, and to identify and understand potential considerations for the implementation of a trauma-informed care programme in an inpatient mental health unit within a paediatric hospital.
We applied the Interpretive Description approach, guided by complexity theory and the Implementation Roadmap, and used Applied Thematic Analysis methods.
Twenty-five individuals participated in individual or group interviews between March and June 2022, including 21 healthcare professionals, 3 youth and 1 caregiver. We identified two overarching themes. The first theme, ‘Understanding and addressing the underlying reasons for distress’, related to participants’ understanding and vision of TIC in the current setting comprising: (a) ‘Participants’ understanding of TIC’; (b) ‘Trauma screening and trauma processing within TIC’; (c) ‘Taking “a more individualized approach”’; (d) ‘Unit programming’; and (e) “Connecting to the community”. The second theme, ‘Factors that support or limit successful TIC implementation’ comprises: (a) ‘The need for a broad “cultural shift”’; (b) ‘The physical environment on the unit’; and (c) ‘Factors that may limit successful implementation’.
We identified five key domains to consider within trauma-informed care implementation: (a) the centrality of engagement with youth, caregivers and staff in trauma-informed care delivery and implementation, (b) trauma-informed care core programme components, (c) factors that may support or limit success in implementing trauma-informed care within the mental health unit and (d) hospital-wide and (e) the importance of intersectoral collaboration (partnering with external organizations and sectors).
When implementing TIC, there is an ongoing need to increase clarity regarding TIC interventions and implementation initiatives. Youth, caregiver and healthcare professional participants shared considerations important for planning the delivery and implementation of trauma-informed care in their setting. We identified five key domains to consider within trauma-informed care implementation: (a) the centrality of relational engagement, (b) trauma-informed care programme components, (c) factors that may support or limit successful implementation of trauma-informed care within the mental health unit and (d) hospital-wide and (e) the importance of intersectoral collaboration. Organizations wishing to implement trauma-informed care should consider ongoing engagement with all relevant knowledge user groups throughout the process.
Standards for Reporting Qualitative Research (SRQR).
The local hospital research institute's Patient and Family Advisory Committee reviewed the draft study methods and provided feedback.
In a small percentage of patients, pulmonary nodules found on CT scans are early lung cancers. Lung cancer detected at an early stage has a much better prognosis. The British Thoracic Society guideline on managing pulmonary nodules recommends using multivariable malignancy risk prediction models to assist in management. While these guidelines seem to be effective in clinical practice, recent data suggest that artificial intelligence (AI)-based malignant-nodule prediction solutions might outperform existing models.
This study is a prospective, observational multicentre study to assess the clinical utility of an AI-assisted CT-based lung cancer prediction tool (LCP) for managing incidental solid and part solid pulmonary nodule patients vs standard care. Two thousand patients will be recruited from 12 different UK hospitals. The primary outcome is the difference between standard care and LCP-guided care in terms of the rate of benign nodules and patients with cancer discharged straight after the assessment of the baseline CT scan. Secondary outcomes investigate adherence to clinical guidelines, other measures of changes to clinical management, patient outcomes and cost-effectiveness.
This study has been reviewed and given a favourable opinion by the South Central—Oxford C Research Ethics Committee in UK (REC reference number: 22/SC/0142).
Study results will be available publicly following peer-reviewed publication in open-access journals. A patient and public involvement group workshop is planned before the study results are available to discuss best methods to disseminate the results. Study results will also be fed back to participating organisations to inform training and procurement activities.
A comprehensive patient assessment is essential for safe patient care. Patient assessment frameworks for nurses are generally restricted to patients who already have altered vital signs and are at risk of deterioration, or to specific risks or body systems such as falls, pressure injury and the Glasgow Coma Score. Comprehensive and structured evidence-based nursing assessment frameworks that consider the whole patient and extend beyond vital signs, specific risks and single systems are not routinely used in inpatient settings but are important to establish early risks for patient deterioration.
The aim of this review was to identify nursing assessment tools or frameworks used to holistically assess hospitalized patients and to identify the impact of these tools on patient and health service outcomes.
A scoping literature review was conducted. Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index of Nursing and Allied Health Literature (CINAHL), ProQuest Dissertations and Thesis, Embase and Scopus were databases used in the search. The initial search was conducted in August 2021 and repeated in November 2022. No date parameters were set. The Participants, Concept, Context (PCC) framework was used to guide the development of the research question and consolidate inclusion and exclusion criteria. The PRISMA-ScR Checklist Item was followed to ensure a methodologically sound checklist was used.
Ten primary research studies evaluating six nursing assessment frameworks were included. Of the five nursing assessment frameworks, none were explicitly designed for general ward nursing, but rather the emergency department or specific patient cohorts, such as oncology. Four studies reported on reliability and/or validity; two reported on patient outcomes and four on staff satisfaction.
Evidence-based nursing patient assessment frameworks for use in general inpatient wards are lacking. Existing assessment tools are largely designed for specific patient cohorts, specific body systems or the already deteriorating patient.
A framework to enable a structured approach to patient assessment in this environment is needed for patient safety, consistency in assessment, nursing staff enablement and confidence to escalate care. Routine systematic nursing assessment could also aid timely patient escalation.
What problem did the study address? This study addresses the lack of evidence-based nursing assessment frameworks for use in hospitalized patients. The impact of this is that it highlights the need for an evidence-based, whole of patient assessment framework for use by nurses for patients admitted to a ward environment.
What were the main findings? This review identified limited comprehensive, patient assessment frameworks for use in general ward inpatient areas. Those identified were not validated for this patient cohort and are aimed at patients already deteriorating.
Where and on whom will the research have an impact? This review has the potential to impact future research and patient care. It highlights that most research is focussed on processes to detect and escalate care for the already deteriorating patient. There is a need for an evidence-based routine nursing assessment framework for patients admitted to a ward environment to promote positive patient outcomes and prevent deterioration.
This review contributes to existing knowledge of nursing patient assessment frameworks, yet it also highlights several gaps. Currently, there are no known, validated, holistic, structured nursing patient assessment frameworks for use in general ward inpatient settings. However, areas that do use such assessment frameworks (e.g. the emergency department) have shown positive patient outcomes and staff usability. Hospitalized ward patients would benefit from routine, structured nursing assessments targeting positive patient outcomes prior to the onset of deterioration.
Little research exists on how risk scores are used in counselling. We examined (a) how Breast Cancer Risk Assessment Tool (BCRAT) scores are presented during counselling; (b) how women react and (c) discuss them afterwards.
Consultations were video-recorded and participants were interviewed after the consultation as part of the NRG Oncology/National Surgical Adjuvant Breast and Bowel Project Decision-Making Project 1 (NSABP DMP-1).
Two NSABP DMP-1 breast cancer care centres in the USA: one large comprehensive cancer centre serving a high-risk population and an academic safety-net medical centre in an urban setting.
Thirty women evaluated for breast cancer risk and their counselling providers were included.
Participants who were identified as at increased risk of breast cancer were recruited to participate in qualitative study with a video-recorded consultation and subsequent semi-structured interview that included giving feedback and input after viewing their own consultation. Consultation videos were summarised jointly and inductively as a team.tThe interview material was searched deductively for text segments that contained the inductively derived themes related to risk assessment. Subgroup analysis according to demographic variables such as age and Gail score were conducted, investigating reactions to risk scores and contrasting and comparing them with the pertinent video analysis data. From this, four descriptive categories of reactions to risk scores emerged. The descriptive categories were clearly defined after 19 interviews; all 30 interviews fit principally into one of the four descriptive categories.
Risk scores were individualised and given meaning by providers through: (a) presenting thresholds, (b) making comparisons and (c) emphasising or minimising the calculated risk. The risk score information elicited little reaction from participants during consultations, though some added to, agreed with or qualified the provider’s information. During interviews, participants reacted to the numbers in four primary ways: (a) engaging easily with numbers; (b) expressing greater anxiety after discussing the risk score; (c) accepting the risk score and (d) not talking about the risk score.
Our study highlights the necessity that patients’ experiences must be understood and put into relation to risk assessment information to become a meaningful treatment decision-making tool, for instance by categorising patients’ information engagement into types.
Self-collected samples (SCS) for sexually transmitted infection (STI) testing have been shown to be feasible and acceptable in high-resource settings. However, few studies have assessed the acceptability of SCS for STI testing in a general population in low-resource settings. This study explored the acceptability of SCS among adults in south-central Uganda.
Nested within the Rakai Community Cohort Study, we conducted semistructured interviews with 36 adults who SCS for STI testing. We analysed the data using an adapted version of the Framework Method.
Overall, SCS was acceptable to both male and female participants, regardless of whether they reported recent STI symptoms. Perceived advantages of SCS over provider-collection included increased privacy and confidentiality, gentleness and efficiency. Disadvantages included the lack of provider involvement, fear of self-harm and the perception that SCS was unhygienic. Most participants preferred provider-collected samples to SCS. Nevertheless, almost all said they would recommend SCS and would do it again in the future.
SCS are acceptable among adults in this low-resource setting and could be offered as an additional option to expand STI diagnostic services.
In Australia, only 22% of male and 8% of female adolescents meet the muscle-strengthening physical activity guidelines, and few school-based interventions support participation in resistance training (RT). After promising findings from our effectiveness trial, we conducted a state-wide dissemination of the ‘Resistance Training for Teens’ (RT4T) intervention from 2015 to 2020. Despite high estimated reach, we found considerable variability in programme delivery and teachers reported numerous barriers to implementation. Supporting schools when they first adopt evidence-based programmes may strengthen programme fidelity, sustainability, and by extension, programme impact. However, the most effective implementation support model for RT4T is unclear.
To compare the effects of three implementation support models on the reach (primary outcome), dose delivered, fidelity, sustainability, impact and cost of RT4T.
We will conduct a hybrid type III implementation–effectiveness trial involving grade 9 and 10 (aged 14–16 years) students from 90 secondary schools in New South Wales (NSW), Australia. Schools will be recruited across one cohort in 2023, stratified by school type, socioeconomic status and location, and randomised in a 1:1:1 ratio to receive one of the following levels of implementation support: (1) ‘low’ (training and resources), (2) ‘moderate’ (training and resources+external support) or ‘high’ (training and resources+external support+equipment). Training includes a teacher workshop related to RT4T programme content (theory and practical sessions) and the related resources. Additional support will be provided by trained project officers from five local health districts. Equipment will consist of a pack of semiportable RT equipment (ie, weighted bars, dumbbells, resistance bands and inverted pull up bar stands) valued at ~$A1000 per school. Study outcomes will be assessed at baseline (T0), 6 months (T1) and 18 months (T2). A range of quantitative (teacher logs, observations and teacher surveys) and qualitative (semistructured interviews with teachers) methods will be used to assess primary (reach) and secondary outcomes (dose delivered, fidelity, sustainability, impact and cost of RT4T). Quantitative analyses will use logistic mixed models for dichotomous outcomes, and ordinal or linear mixed effects regression models for continuous outcomes, with alpha levels set at p
Ethics approval has been obtained from the University of Newcastle (H-2021-0418), the NSW Department of Education (SERAP:2022215), Hunter New England Human Research Ethics Committee (2023/ETH00052) and the Catholic Schools Office. The design, conduct and reporting will adhere to the Consolidated Standards of Reporting Trials statement, the Standards for Reporting Implementation Studies statement and the Template for Intervention Description and Replication checklist. Findings will be published in open access peer-reviewed journals, key stakeholders will be provided with a detailed report. We will support ongoing dissemination of RT4T in Australian schools via professional learning for teachers.
ACTRN12622000861752.
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