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Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer trial study protocol: a randomised clinical trial of fibre-rich legumes targeting the gut microbiome, metabolome and gut transit time of overweight and obese patients with a history of noncancerou

Por: Hartman · T. J. · Christie · J. · Wilson · A. · Ziegler · T. R. · Methe · B. · Flanders · W. D. · Rolls · B. J. · Loye Eberhart · B. · Li · J. V. · Huneault · H. · Cousineau · B. · Perez · M. R. · O'Keefe · S. J. D.
Introduction

Recently published studies support the beneficial effects of consuming fibre-rich legumes, such as cooked dry beans, to improve metabolic health and reduce cancer risk. In participants with overweight/obesity and a history of colorectal polyps, the Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer randomised clinical trial will test whether a high-fibre diet featuring legumes will simultaneously facilitate weight reduction and suppress colonic mucosal biomarkers of colorectal cancer (CRC).

Methods/design

This study is designed to characterise changes in (1) body weight; (2) biomarkers of insulin resistance and systemic inflammation; (3) compositional and functional profiles of the faecal microbiome and metabolome; (4) mucosal biomarkers of CRC risk and (5) gut transit. Approximately 60 overweight or obese adults with a history of noncancerous adenomatous polyps within the previous 3 years will be recruited and randomised to one of two weight-loss diets. Following a 1-week run-in, participants in the intervention arm will receive preportioned high-fibre legume-rich entrées for two meals/day in months 1–3 and one meal/day in months 4–6. In the control arm, entrées will replace legumes with lean protein sources (eg, chicken). Both groups will receive in-person and written guidance to include nutritionally balanced sides with energy intake to lose 1–2 pounds per week.

Ethics and dissemination

The National Institutes of Health fund this ongoing 5-year study through a National Cancer Institute grant (5R01CA245063) awarded to Emory University with a subaward to the University of Pittsburgh. The study protocol was approved by the Emory Institutional Review Board (IRB approval number: 00000563).

Trial registration number

NCT04780477.

Validation of a web-based self-administered test for cognitive assessment in a Swedish geriatric setting

by Einar Rystedt, Jakob Morén, Johan Lindbäck, Vitor Tedim Cruz, Martin Ingelsson, Lena Kilander, Nuno Lunet, Joana Pais, Luis Ruano, Gabriel Westman

Computerized cognitive tests have the potential to cost-effectively detect and monitor cognitive impairments and thereby facilitate treatment for these conditions. However, relatively few of these tests have been validated in a variety of populations. Brain on Track, a self-administered web-based test, has previously been shown to have a good ability to differentiate between healthy individuals and patients with cognitive impairment in Portuguese populations. The objective of this study was to validate the differential ability and evaluate the usability of Brain on Track in a Swedish memory clinic setting. Brain on Track was administered to 30 patients with mild cognitive impairment/mild dementia and 30 healthy controls, all scheduled to perform the test from home after one week and after three months. To evaluate the usability, the patient group was interviewed after completion of the testing phase. Patients scored lower than healthy controls at both the first (median score 42.4 vs 54.1, p

School health professionals understanding of culture: a scoping review protocol

Por: Wahlström · E. · Landerdahl Stridsberg · S. · Larsson · C. · Stier · J.
Introduction

Culture is highlighted in previous research as important in encounters where health professionals and children do not share a language or culture. In these encounters, culture is described as mainly related to the child, whereas the health professionals’ understanding of their own culture as impacting the encounter tends to be left out. To clarify how culture is understood and conceptualised among professionals, it is of relevance to collate previous research on health professionals’ understanding of culture. In the scoping review that this protocol describes, we aim to focus on the context of the school health services, being a context accessible to many children in their everyday life. The aim of the review will be to identify, describe and analyse previous research concerning school health professionals’ (ie, school nurses, school social workers, school doctors and school psychologists) understanding of culture.

Methods and analysis

This scoping review will be guided by the methodology described by Peters et al and Khalil et al. Searches will be conducted in Scopus, PubMed, Cinahl Plus, SocIndex, Sociological Abstracts, Social Services Abstracts, APA PsycInfo, APA PsycArticles, Web of Science and Applied Social Sciences Index & Abstracts (ASSIA). Any published scientific papers focusing on school health professionals’ understanding of culture (conceptualised through a variety of related terms) and school health services conducted within the last 10 years (2013–2023) will be included. Two reviewers will independently screen all titles and abstracts for inclusion. Two reviewers will conduct the screening of full-text documents and the extraction of information. Qualitative content analysis as well as discourse analysis will be employed.

Ethics and dissemination

Ethical approval is not required for this study. The findings will be disseminated through peer review publication as well as presentation at conferences and to relevant stakeholders.

Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the e

Por: Engdahl · J. · Straat · K. · Isaksson · E. · Rooth · E. · Svennberg · E. · Norrving · B. · Euler · M. v. · Hellqvist · K. · Gu · W. · Ström · J. O. · Själander · S. · Eriksson · M. · Asberg · S. · Wester · P.
Introduction

Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.

Methods and analysis

AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24–72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023–2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.

Ethics and dissemination

Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021–02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice.

Trial registration number

NCT05134454.

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