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Good School Toolkit-Secondary Schools to prevent violence against students: protocol for a pilot cluster randomised controlled trial

Por: Devries · K. · Tanton · C. · Knight · L. · Nakuti · J. · Nanyunja · B. · Laruni · Y. · Amollo · M. · Apota · J. · Opobo · T. · Pearlman · J. · Allen · E. · Bonell · C. · Naker · D.
Introduction

No whole-school interventions which seek to reduce physical, sexual and emotional violence from peers, intimate partners and teachers have been trialled with adolescents. Here, we report a protocol for a pilot trial of the Good School Toolkit-Secondary Schools intervention, to be tested in Ugandan secondary schools. Our main objectives are to (1) refine the intervention, (2) to understand feasibility of delivery of the intervention and (3) to explore design parameters for a subsequent phase III trial.

Methods and analysis

We will conduct a pilot cluster randomised controlled trial, with two arms and parallel assignment. Eight schools will be randomly selected from a stratified list of all eligible schools in Kampala and Wakiso Districts. We will conduct a baseline survey and endline survey 18 months after the baseline, with 960 adolescents and 200 teachers. Qualitative data and mixed methods process data collection will be conducted throughout the intervention. Proportion of staff and students reporting acceptability, understanding and implementing with fidelity will be tabulated at endline for intervention schools. Proportions of schools consenting to participation, randomisation and proportions of schools and individual participants completing the baseline and endline surveys will be described in a Consolidated Standards of Reporting Trials diagram.

Ethics and dissemination

The ethical requirements of our project are complex. Full approvals have been received from the Mildmay Ethics Committee (0407-2019), the Uganda National Council for Science and Technology (SS 6020) and the London School of Hygiene & Tropical Medicine (16212). Results of this study will be published in peer-reviewed academic journals, and shared with public bodies, policy makers, study participants and the general public in Uganda.

Trial registration number

PACTR202009826515511.

Exploring perceptions of gender roles amongst sexually active adolescents in rural KwaZulu-Natal, South Africa

by Brett Marshall, Celia Mehou-Loko, Sindisiwe Mazibuko, Makhosazana Madladla, Lucia Knight, Hilton Humphries

Traditional gender and social norms reinforce asymmetrical power relations, increase the risk of experiencing gender-based violence and mediate poor engagement with sexual and reproductive health services. This study explored gender norms and expectations amongst cisgender adolescents in rural KwaZulu-Natal, South Africa. A purposive sample of 29 adolescents aged 16–19 years old were enrolled as part of a longitudinal qualitative study. The current analysis reports on the first round of in-depth interviews, which focused on the role of men and women in their community. A theoretically informed thematic analysis identified three broad themes: 1) Adolescent interpretation and understanding of gender identity, 2) Gendered essentialism and Gender roles (two sub-themes: Young men: Power through providing, and Young women: The domestication process which highlighted that gender roles were defined by being the provider for men, and the successful fulfilment of traditional domestic behaviours amongst women), 3) Gender and fertility highlighted how participants highly valued fertility as affirming of manhood/womanhood. These norms reinforce gender roles that maintain asymmetrical power relations, carrying them over into adulthood. The subtle social pressure to prove fertility could have unintended consequences for driving teenage pregnancy. Structural, gender-based interventions emphasising positive gender-role development in early childhood are needed.

Third delay in care of critically ill patients: a qualitative investigation of public hospitals in Kenya

Por: Onyango · O. O. · Willows · T. M. · McKnight · J. · Schell · C. O. · Baker · T. · Mkumbo · E. · Maiba · J. · Khalid · K. · English · M. · Oliwa · J. N.
Objectives

Third delay refers to delays in delivering requisite care to patients after they arrive at a health facility. In low-resource care settings, effective triage and flow of care are difficult to guarantee. In this study, we aimed to identify delays in the delivery of care to critically ill patients and possible ways to address these delays.

Design

This was an exploratory qualitative study using in-depth interviews and patient journeys. The qualitative data were transcribed and aggregated into themes in NVivo V.12 Plus using inductive and deductive approaches.

Setting

This study was conducted in four secondary-level public Kenyan hospitals across four counties between March and December 2021. The selected hospitals were part of the Clinical Information Network.

Participants

Purposive sampling method was used to identify administrative and front-line healthcare providers and patients. We conducted 12 in-depth interviews with 11 healthcare workers and patient journeys of 7 patients. Informed consent was sought from the participants and maintained throughout the study.

Results

We identified a cycle of suboptimal systems for care with adaptive mechanisms that prevent quality care to critically ill patients. We identified suboptimal systems for identification of critical illness, inadequate resources for continuity care and disruption of the flow of care, as the major causes of delays in identification and the initiation of essential care to critically ill patients. Our study also illuminated the contribution of inflexible bureaucratic non-clinical business-related organisational processes to third delay.

Conclusion

Eliminating or reducing delays after patients arrive at the hospital is a time-sensitive measure that could improve the care outcomes of critically ill patients. This is achievable through an essential emergency and critical care package within the hospitals. Our findings can help emphasise the need for standardised effective and reliable care priorities to maintain of care of critically ill patients.

REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system

Por: Holder-Murray · J. · Esper · S. A. · Althans · A. R. · Knight · J. · Subramaniam · K. · Derenzo · J. · Ball · R. · Beaman · S. · Luke · C. · La Colla · L. · Schott · N. · Williams · B. · Lorenzi · E. · Berry · L. R. · Viele · K. · Berry · S. · Masters · M. · Meister · K. A. · Wilkinson · T.
Introduction

Implementation of enhanced recovery pathways (ERPs) has resulted in improved patient-centred outcomes and decreased costs. However, there is a lack of high-level evidence for many ERP elements. We have designed a randomised, embedded, multifactorial, adaptive platform perioperative medicine (REMAP Periop) trial to evaluate the effectiveness of several perioperative therapies for patients undergoing complex abdominal surgery as part of an ERP. This trial will begin with two domains: postoperative nausea/vomiting (PONV) prophylaxis and regional/neuraxial analgesia. Patients enrolled in the trial will be randomised to arms within both domains, with the possibility of adding additional domains in the future.

Methods and analysis

In the PONV domain, patients are randomised to optimal versus supraoptimal prophylactic regimens. In the regional/neuraxial domain, patients are randomised to one of five different single-injection techniques/combination of techniques. The primary study endpoint is hospital-free days at 30 days, with additional domain-specific secondary endpoints of PONV incidence and postoperative opioid consumption. The efficacy of an intervention arm within a given domain will be evaluated at regular interim analyses using Bayesian statistical analysis. At the beginning of the trial, participants will have an equal probability of being allocated to any given intervention within a domain (ie, simple 1:1 randomisation), with response adaptive randomisation guiding changes to allocation ratios after interim analyses when applicable based on prespecified statistical triggers. Triggers met at interim analysis may also result in intervention dropping.

Ethics and dissemination

The core protocol and domain-specific appendices were approved by the University of Pittsburgh Institutional Review Board. A waiver of informed consent was obtained for this trial. Trial results will be announced to the public and healthcare providers once prespecified statistical triggers of interest are reached as described in the core protocol, and the most favourable interventions will then be implemented as a standardised institutional protocol.

Trial registration number

NCT04606264.

Protocol for the Tallaght University Hospital Institute for Memory and Cognition-Biobank for Research in Ageing and Neurodegeneration

Por: Dyer · A. H. · Dolphin · H. · OConnor · A. · Morrison · L. · Sedgwick · G. · McFeely · A. · Killeen · E. · Gallagher · C. · Davey · N. · Connolly · E. · Lyons · S. · Young · C. · Gaffney · C. · Ennis · R. · McHale · C. · Joseph · J. · Knight · G. · Kelly · E. · OFarrelly · C. · Bourke · N. M.
Introduction

Alzheimer’s disease and other dementias affect >50 million individuals globally and are characterised by broad clinical and biological heterogeneity. Cohort and biobank studies have played a critical role in advancing the understanding of disease pathophysiology and in identifying novel diagnostic and treatment approaches. However, further discovery and validation cohorts are required to clarify the real-world utility of new biomarkers, facilitate research into the development of novel therapies and advance our understanding of the clinical heterogeneity and pathobiology of neurodegenerative diseases.

Methods and analysis

The Tallaght University Hospital Institute for Memory and Cognition Biobank for Research in Ageing and Neurodegeneration (TIMC-BRAiN) will recruit 1000 individuals over 5 years. Participants, who are undergoing diagnostic workup in the TIMC Memory Assessment and Support Service (TIMC-MASS), will opt to donate clinical data and biological samples to a biobank. All participants will complete a detailed clinical, neuropsychological and dementia severity assessment (including Addenbrooke’s Cognitive Assessment, Repeatable Battery for Assessment of Neuropsychological Status, Clinical Dementia Rating Scale). Participants undergoing venepuncture/lumbar puncture as part of the clinical workup will be offered the opportunity to donate additional blood (serum/plasma/whole blood) and cerebrospinal fluid samples for longitudinal storage in the TIMC-BRAiN biobank. Participants are followed at 18-month intervals for repeat clinical and cognitive assessments. Anonymised clinical data and biological samples will be stored securely in a central repository and used to facilitate future studies concerned with advancing the diagnosis and treatment of neurodegenerative diseases.

Ethics and dissemination

Ethical approval has been granted by the St. James’s Hospital/Tallaght University Hospital Joint Research Ethics Committee (Project ID: 2159), which operates in compliance with the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 and ICH Good Clinical Practice Guidelines. Findings using TIMC-BRAiN will be published in a timely and open-access fashion.

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