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Rituximab-combined anthracycline-free chemotherapy in newly diagnosed paediatric and adolescent patients with non-high-risk aggressive mature B cell lymphoma: protocol for a single-arm, open-label, multicentre, phase II study (the Japan Childrens Cancer G

Por: Sekimizu · M. · Fukano · R. · Koga · Y. · Mitsui · T. · Fujita · N. · Mori · T. · Hori · D. · Tanaka · M. · Ohki · K. · Iwafuchi · H. · Nakazawa · A. · Mori · T. · Kobayashi · R. · Hashimoto · H. · M. Saito · A. · Kamei · M. · on behalf of Lymphoma Committee of Japan Childrens Cancer G
Introduction

Children and adolescents with mature B cell non-Hodgkin lymphoma (B-NHL) are treated with short-intensive chemotherapy. The burden of short-term and long-term toxicity is highly relative to its high cure rate in good-risk patients. Although the addition of rituximab to standard lymphome Malin B (LMB) chemotherapy markedly prolongs event-free survival and overall survival in high-risk patients, the benefit of rituximab in good-risk patients remains to be elucidated. This clinical trial will examine whether the addition of rituximab eliminates anthracyclines in good-risk patients without compromising treatment outcomes.

Methods and analysis

We will perform a single-arm, open-label, multicentre phase II study. Low-risk (stage I – completely resected, stage II abdominal) and intermediate-risk (stages I and II – incompletely resected; stage II – resected, other than abdominal; stage III with LDH x upper limit of normal) patients with newly diagnosed B-NHL are eligible. Low-risk patients receive two courses of R-COM1P (rituximab, cyclophosphamide, vincristine, methotrexate, prednisolone and intrathecal methotrexate with hydrocortisone), and intermediate-risk patients receive COP (cyclophosphamide, vincristine, prednisolone and intrathecal methotrexate with hydrocortisone) followed by two courses each of R-COM3P and R-CYM (rituximab, cytarabine, methotrexate and intrathecal methotrexate with hydrocortisone). The primary endpoint is a 3-year event-free survival rate in paediatric patients (

Ethics and dissemination

This research was approved by the Certified Review Board at NHO Nagoya Medical Center (Nagoya, Japan) on 21 September 2021. Written informed consent is obtained from all patients and/or their guardians. The results of this study will be disseminated through peer-reviewed publications and conference presentations.

Study registration

Japan Registry of Clinical Trials, jRCTs041210104.

Developing blood-brain barrier arterial spin labelling as a non-invasive early biomarker of Alzheimers disease (DEBBIE-AD): a prospective observational multicohort study protocol

Por: Padrela · B. · Mahroo · A. · Tee · M. · Sneve · M. H. · Moyaert · P. · Geier · O. · Kuijer · J. P. A. · Beun · S. · Nordhoy · W. · Zhu · Y. D. · Buck · M. A. · Hoinkiss · D. C. · Konstandin · S. · Huber · J. · Wiersinga · J. · Rikken · R. · de Leeuw · D. · Grydeland · H. · Tippett · L. · Caw
Introduction

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).

Methods and analysis

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 and dissemination

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.

Screening for the risk of canine impaction, what are the presumptive signs and how does it affect orthodontics? A cross-sectional study in France

by Damien Brézulier, Steeven Carnet, Alexia Marie-Cousin, Jean-Louis Sixou

Purpose

The treatment of impacted canines is a challenge for orthodontists. The availability of suggestive clinical signs has become crucial for treatment before the potential for evolution ceases. The main objective was to evaluate the prevalence of the suspected displaced canine (SDC) and to highlight factors easily identifiable from the oral examination.

Methods

SDC was assessed on panoramic X-rays, on the basis of the angle with the median sagittal plane and the degree of overlap with the permanent lateral incisor. Its association with mesio-distal tooth and palate widths was assessed by univariate analysis. Next, the association of SDC with temporary tooth extraction, expansion and/or premolar extraction was considered using the same modality.

Results

In this retrospective study, the records of 292 patients aged 7 to 13 years were reviewed. SDC was detected in 39% of patients i.e., 28,8% of observed canines. Reduced coronal mesio-distal diameters of permanent maxillary central incisors, 8.7 ± 0.6 mm versus 8.8 ± 0.7 mm (p Conclusion

This study confirmed the interest of panoramic X-rays in detected canines at risk of SDC. Dental factors can be combined to make screening more reliable and predict impaction that makes orthodontics complex.

Trial registration number

Opinion n°21.131, dated 09.21.2021, retrospectively registered.

Quality and safety issue: language barriers in healthcare, a qualitative study of non-Arab healthcare practitioners caring for Arabic patients in the UAE

Por: Al-Yateem · N. · Hijazi · H. · Saifan · A. R. · Ahmad · A. · Masa'Deh · R. · Alrimawi · I. · Rahman · S. A. · Subu · M. A. · Ahmed · F. R.
Objectives

To identify language-related communication barriers that expatriate (non-Arabic) healthcare practitioners in the UAE encounter in their daily practice.

Design

Qualitative study utilising semi-structured in-depth interviews. The interviews were conducted in English language.

Setting

Different healthcare facilities across the UAE. These facilities were accessed for data collection over a period of 3 months from January 2023 to March 2023.

Participants

14 purposively selected healthcare practitioners.

Intervention

No specific intervention was implemented; this study primarily aimed at gaining insights through interviews.

Primary and secondary outcomes

To understand the implications of language barriers on service quality, patient safety, and healthcare providers’ well-being.

Results

Three main themes emerged from our analysis of participants’ narratives: Feeling left alone, Trying to come closer to their patients and Feeling guilty, scared and dissatisfied.

Conclusions

Based on the perspectives and experiences of participating healthcare professionals, language barriers have notably influenced the delivery of healthcare services, patient safety and the well-being of both patients and practitioners in the UAE. There is a pressing need, as highlighted by these professionals, for the inclusion of professional interpreters and the provision of training to healthcare providers to enhance effective collaboration with these interpreters.

Acceptability of aspirin for cancer preventive therapy: a survey and qualitative study exploring the views of the UK general population

Por: Lloyd · K. E. · Hall · L. H. · Ziegler · L. · Foy · R. · Green · S. M. C. · MacKenzie · M. · Taylor · D. G. · Smith · S. G. · Aspirin for Cancer Prevention AsCaP Steering Committee · Cuzick · Balkwill · Bishop · Burn · Chan · Crooks · Hawkey · Langley · McKenzie · Nedjai · Patrign
Objectives

Aspirin could be offered for colorectal cancer prevention for the UK general population. To ensure the views of the general population are considered in future guidance, we explored public perceptions of aspirin for preventive therapy.

Design

We conducted an online survey to investigate aspirin use, and awareness of aspirin for cancer prevention among the UK general population. We conducted semistructured interviews with a subsample of survey respondents to explore participants’ acceptability towards aspirin for cancer preventive therapy. We analysed the interview data using reflexive thematic analysis and mapped the themes onto the Theoretical Domains Framework, and the Necessity and Concerns Framework.

Setting

Online survey and remote interviews.

Participants

We recruited 400 UK respondents aged 50–70 years through a market research company to the survey. We purposefully sampled, recruited and interviewed 20 survey respondents.

Results

In the survey, 19.0% (76/400) of respondents were aware that aspirin can be used to prevent cancer. Among those who had previously taken aspirin, 1.9% (4/216) had taken it for cancer prevention. The interviews generated three themes: (1) perceived necessity of aspirin; (2) concerns about side effects; and (3) preferred information sources. Participants with a personal or family history of cancer were more likely to perceive aspirin as necessary for cancer prevention. Concerns about taking aspirin at higher doses and its side effects, such as gastrointestinal bleeding, were common. Many described wanting guidance and advice on aspirin to be communicated from sources perceived as trustworthy, such as healthcare professionals.

Conclusions

Among the general population, those with a personal or family history of cancer may be more receptive towards taking aspirin for preventive therapy. Future policies and campaigns recommending aspirin may be of particular interest to these groups. Multiple considerations about the benefits and risks of aspirin highlight the need to support informed decisions on the medication.

Attitudes towards LGBTQ+ individuals among Thai medical students

by Teeravut Wiwattarangkul, Sorawit Wainipitapong

Background

The global population of individuals with gender diversity or LGBTQ+ people is on the rise. However, negative attitudes towards LGBTQ+ individuals persist, even among healthcare professionals, creating barriers to healthcare access. These attitudes are influenced by cultural variations worldwide and necessitate investigation across diverse cultures and settings.

Objectives

This study aimed to evaluate the attitudes towards LGBTQ+ people and describe associated factors with being LGBTQ+ among Thai medical students.

Methods

During the 2021 academic year, a survey was conducted at a medical school in Bangkok, Thailand, collecting demographic data and attitudes measured by a standardised Thai questionnaire. Descriptive statistics as well as bivariate and multivariable logistic regression analyses were used to describe characteristics and association.

Results

A total of 806 medical students participated, with a neutral attitude being the most prevalent (72.2%), followed by a positive attitude (27.2%), and a minority reporting a negative attitude (0.6%). Bivariate and multivariable logistic regression analyses revealed significant associations between positive attitudes and female sexual identity (aOR 2.02, 95%CI 1.45–2.81, p-value Conclusion

Positive attitude towards the LGBTQ+ community are essential for physicians, emphasising the need to study factors that contribute to positive attitudes in order to foster an LGBTQ+-friendly environment for both patients and medical students.

Independent and joint associations of cardiorespiratory fitness and BMI with dementia risk: the Cooper Center Longitudinal Study

Por: Gafni · T. · Weinstein · G. · Leonard · D. · Barlow · C. E. · DeFina · L. F. · Pettee Gabriel · K. · Berry · J. D. · Shuval · K.
Objective

This study aimed to examine the association of midlife fitness and body mass index (BMI) with incident dementia later in life.

Design and participants

A cohort study of 6428 individuals (mean age 50.9±7.6 years) from the Cooper Center Longitudinal Study.

Measures

Cardiorespiratory fitness and BMI were assessed twice (1970–1999) during visits to the Cooper Clinic, a preventive medicine clinic in Dallas, Texas. These measures were examined as continuous and categorical variables. As continuous variables, fitness and BMI were examined at baseline (averaged of two examinations) and as absolute change between exams (mean time 2.1±1.8 years). Variables were categorised: unfit versus fit and normal versus overweight/obese. Medicare claims data were used to obtain all-cause dementia incidence (1999–2009). Mean follow-up between midlife examinations and Medicare surveillance was 15.7 ((SD=6.2) years. Multivariable models were used to assess the associations between fitness, BMI and dementia.

Results

During 40 773 person years of Medicare surveillance, 632 cases of dementia were identified. After controlling for BMI and covariates, each 1-metabolic equivalent increment in fitness was associated with 5% lower (HR 0.95; 95% CI 0.90 to 0.99) dementia risk. In comparison, after controlling for fitness and covariates, each 1 kg/m2 increment in BMI was associated with a 3.0% (HR 1.03; 95% CI 1.00 to 1.07) higher risk for dementia, yet without significance (p=0.051). Similar findings were observed when the exposures were categorised. Changes in fitness and BMI between examinations were not related to dementia. Jointly, participants who were unfit and overweight/obese had the highest (HR 2.28 95% CI 1.57 to 3.32) dementia risk compared with their fit and normal weight counterparts.

Conclusion

Lower midlife fitness is a risk marker for dementia irrespective of weight status. Being unfit coupled with overweight/obese status might increase one’s risk for dementia even further.

Metformin for knee osteoarthritis with obesity: study protocol for a randomised, double-blind, placebo-controlled trial

Por: Lim · Y. Z. · Wang · Y. · Urquhart · D. M. · Estee · M. M. · Wluka · A. E. · Heritier · S. · Cicuttini · F. M.
Introduction

Over half of the populations with knee osteoarthritis (OA) have obesity. These individuals have many other shared metabolic risk factors. Metformin is a safe, inexpensive, well-tolerated drug that has pleiotropic effects, including structural protection, anti-inflammatory and analgesic effects in OA, specifically the knee. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether metformin reduces knee pain over 6 months in individuals with symptomatic knee OA who are overweight or obese.

Methods and analysis

One hundred and two participants with symptomatic knee OA and overweight or obesity will be recruited from the community in Melbourne, Australia, and randomly allocated in a 1:1 ratio to receive either metformin 2 g or identical placebo daily for 6 months. The primary outcome is reduction of knee pain [assessed by 100 mm Visual Analogue Scale (VAS)] at 6 months. The secondary outcomes are OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) responder criteria [Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, function and participant’s global assessment (VAS)] at 6 months; change in knee pain, stiffness, function using WOMAC at 6 months and quality of life at 6 months. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups.

Ethics and dissemination

Ethics approval has been obtained from the Alfred Hospital Ethics Committee (708/20) and Monash University Human Research Ethics Committee (28498). Written informed consent will be obtained from all the participants. The findings will be disseminated through peer-review publications and conference presentations.

Trial registration number

ACTRN12621000710820 .

What are best practices for involving family caregivers in interventions aimed at responsive behaviour stemming from unmet needs of people with dementia in nursing homes: a scoping review

Objectives

This study aimed to determine best practices for involving family caregivers in interventions aimed at preventing and reducing responsive behaviour stemming from unmet needs, including pain.

Design

Scoping review, reported according to the Preferred Reporting Items for Systematic Reviews, Meta-Analyses extension for Scoping Reviews reporting guideline.

Data sources

PubMed, Embase, Emcare, Web of Science, COCHRANE Library, PsycINFO, Academic Search Premier and Cinahl searched up to 23 July 2023.

Eligibility criteria

Studies reporting on family involvement in interventions for nursing home residents with dementia were included.

Data extraction and synthesis

Two researchers independently extracted the data, followed by a content analysis.

Results

Of the 1486 records screened, 20 studies were included. Family caregivers were involved in interventions aimed at planning care, life review (eg, documentation of life experiences of their relative), and selecting activities for their relative. Family caregivers preferred an active role in developing optimal care for their relative. Drivers of success and barriers to family involvement centred around three themes: (1) communication between all involved; (2) prerequisites (organisational and other conditions) and (3) personal circumstances (family’s coping and skills).

Conclusion

Best practices for involving family caregivers in interventions aimed at addressing responsive behaviour in residents with dementia concerned those interventions in which family caregivers were given an important role in managing responsive behaviour. This means that, in order to achieve an active role of family caregivers in the whole care process, their needs must be taken into account.

Trial registration number

The protocol of the review was regisered at OSF; https://osf.io/twcfq

The burden of non-disabled frailty and its associated factors among older adults in Bangladesh

by Sabuj Kanti Mistry, A. R. M. Mehrab Ali, Uday Narayan Yadav, Saruna Ghimire, Afsana Anwar, Md. Nazmul Huda, Fouzia Khanam, Rashidul Alam Mahumud, Ateeb Ahmad Parray, Shovon Bhattacharjee, David Lim, Mark Fort Harris

Objective

The present study aims to measure the prevalence of non-disabled frailty and its associated factors among Bangladeshi older adults.

Methods

This cross-sectional study was conducted during September and October 2021 among 1,045 Bangladeshi older adults (≥60 years). Telephone interviews, using a semi-structured questionnaire, were undertaken to collect data on participants’ characteristics and level of frailty. The non-disabled frailty was measured using the ‘Frail Non-Disabled (FiND)’ questionnaire. A multinomial logistic regression model assessed the factors associated with frailty among the participants.

Results

Around a quarter of the participants (24.8%) were frail. The multinomial regression analysis showed that older participants aged ≥80 years (RRR = 3.23, 95% CI: 1.41–7.37) were more likely to be frail compared to participants aged 60–69 years. Likewise, the participants living in a large family with ≥4 members (RRR = 1.39, 95% CI: 1.01–1.92) were more likely to be frail compared to those living in smaller families. Also, participants having memory or concentration problems (RRR = 1.56, 95% CI: 1.12–2.17) were more likely to be frail compared to those who were not suffering from these problems. Moreover, participants whose family members were non-responsive to their day-to-day assistance (RRR = 1.47, 95% CI: 1.06–2.03) were more likely to be frail compared to those whose family members were responsive. Furthermore, participants who were feeling lonely (RRR = 1.45, 95% CI: 1.07–1.98) were more likely to be frail than their counterparts who were not feeling lonely.

Conclusions

The findings of the present study suggest developing tailored interventions to address the burden of frailty among the older populations in Bangladesh. In particular, providing long-term care and health promotion activities can be of value in preventing frailty and reducing adverse health outcomes among this vulnerable population group.

Stratification of risk for emergent intracranial abnormalities in children with headaches: a Pediatric Emergency Care Applied Research Network (PECARN) study protocol

Por: Tsze · D. S. · Kuppermann · N. · Casper · T. C. · Barney · B. J. · Richer · L. P. · Liberman · D. B. · Okada · P. J. · Morris · C. R. · Myers · S. R. · Soung · J. K. · Mistry · R. D. · Babcock · L. · Spencer · S. P. · Johnson · M. D. · Klein · E. J. · Quayle · K. S. · Steele · D. W. · Cr
Introduction

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.

Methods and analysis

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 and dissemination

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.

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