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PRevEnting FracturEs in REnal Disease-1 (PREFERRED-1): protocol for a pilot study of a pragmatic, randomised controlled trial of denosumab for the prevention of fragility fractures in haemodialysis

Por: Clemens · K. K. · Cowan · A. · Dixon · S. · Naylor · K. · Weir · M. A. · Thain · J. · Khan · T. · Silver · S. · Molnar · A. O. · Sultan · N. · Holden · R. M. · Hiremath · S. · Wald · R. · Kitchlu · A. · Arnold · J. · Field · B. · Garg · A. X.
Objective

Patients receiving haemodialysis are at very high risk of fragility fracture, yet there are no proven treatments for fracture prevention. We will advance a pilot study on the feasibility of a large, pragmatic, randomised controlled trial (RCT) of denosumab for fragility fracture prevention in haemodialysis.

Trial design

PRevEnting FracturEs in REnal Disease-1 is a pragmatic, open-label, pilot study of an RCT of a denosumab care pathway embedded in routine care haemodialysis centres.

Methods

We will recruit at least 60 participants at high risk of fracture from at least 6 haemodialysis centres in Ontario, Canada. They must be aged 40 years or older, have access to provincial drug coverage, have appropriate baseline calcium and parathyroid hormone levels and be deemed suitable for denosumab by their kidney care provider. Participants will be randomised 1:1 to denosumab (with supports to mitigate hypocalcaemia) versus usual care using block randomisation by a central statistician (computer-generated sequence). Primary outcomes include recruitment feasibility and adherence. Secondary outcomes include safety (hypocalcaemia) and participant satisfaction with our protocol and processes. Study investigators and data analysts will be blind to treatment allocation.

We will present results descriptively. The trial was approved by Clinical Trials Ontario and local research ethics boards across study sites.

Results

Primary and secondary outcomes will be published on trial completion.

Conclusions

This pilot will inform the feasibility of conducting a large-scale, efficiently run, pragmatic RCT to test whether a denosumab care pathway safely reduces the risk of fragility fracture in patients receiving haemodialysis. Results have the potential to transform fracture care in real-world patients with kidney and metabolic bone disease.

Trial registration number

NCT05096195.

Vulval lichen sclerosus in UK general practice: a cross-sectional survey of patient experience

Por: Rees · S. · Arnold · S. · Parsons · H. · Hillman · S.
Objective

To explore experience and prevalence of vulval lichen sclerosus (VLS) diagnosis in general practice using an anonymous patient survey.

Design

Quantitative descriptive cross-sectional survey informed by previous qualitative interviews and developed with patient representatives, sent to people recorded in general practice as having a VLS diagnosis.

Setting

General practices (n=24) in the UK (West Midlands).

Participants

n=177 respondents.

Results

One in five respondents reported that they had been misdiagnosed, and about a third reported that it was a struggle to get treatment. Only one third said they received regular check-ups, recommended in clinical guidelines. One-fifth reported they were not being treated with topical corticosteroids, the main first-line treatment for VLS. Less than one in 10 were members of a support group, and around four in 10 felt they had to hide their condition and did not speak to anyone else about it. Survey respondents prioritised improving education and awareness among healthcare professionals (HCPs).

Conclusion

General practitioners and other primary care HCPs have a key role in recognising, diagnosing and managing VLS. Improving education and awareness among HCPs was a key priority for this patient group. Patients should be made aware of the need for ongoing treatment and yearly check-ups to prevent or manage disease progression. VLS is a highly stigmatised condition, and appointments with HCPs may be the only opportunity for people to talk about their experience.

Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition (AMOUR): study protocol for a double-masked randomised controlled trial

Por: Bountogo · M. · Zakane · A. · Ouedraogo · T. A. · Ouermi · L. · Compaore · G. · Compaore · A. · Coulibaly · B. · Koueta · F. · Burroughs · H. R. · Fetterman · I. · La Mons · J. L. · Lebas · E. · Doan · T. · Hsiang · M. · OBrien · K. S. · Arnold · B. · Sie · A. · Oldenburg · C. E.
Introduction

Amoxicillin is recommended for children with uncomplicated severe acute malnutrition (SAM). However, some trials have shown no difference in amoxicillin for nutritional recovery in children with SAM compared with placebo. In addition, amoxicillin treatment requires two times per day dosing for 7 days, which may influence adherence. Azithromycin is a broad-spectrum antibiotic that can be provided as a single dose and has reduced mortality in children aged 1–59 months when provided by mass drug administration. The AMOUR trial is designed to assess amoxicillin, azithromycin and placebo as part of outpatient treatment of uncomplicated SAM.

Methods and analysis

This double-masked randomised controlled trial will enrol 3000 children over 3 years in an individually randomised 1:1:1 allocation to azithromycin, amoxicillin or placebo arms and follow them for 12 months. Children eligible to enrol in the study will be aged 6–59 months and have uncomplicated non-oedematous SAM as defined by weight-for-height Z-score

Ethics and dissemination

Ethical approval was obtained from the Institutional Review Board at the University of California, San Francisco (Protocol 23–39411) and the Comité d’Ethique pour la Recherche en Santé in Ouagadougou, Burkina Faso (Protocol 2024-01-08). The results of this study will be disseminated to the Ministry of Health, community stakeholders and via peer-reviewed publications and academic conferences.

Trial registration number

NCT06010719.

Early intervention in autism: where do we go from here?

Por: Cary · E. · Arnold · E.

Commentary on: Autism intervention meta-analysis of early childhood studies (Project AIM): updated systematic review and secondary analysis - Sandbank et al 2023

Implications for practice and research

  • Nurses may consider advocating for autistic clients by recommending naturalistic developmental behavioural intervention and other early interventions when appropriate and providing multidisciplinary care in collaboration with interventionists.

  • More robust research methods are needed, including randomised controlled trials of early interventions for autism that assess adverse effects to ensure benefits outweigh any risks.

  • Context

    Behaviourists pioneered early intervention for autism in the 1960s using operant learning principles. The intervention was dubbed applied behavioural analysis (ABA). In the 1990s, naturalistic developmental behavioural intervention (NDBI) expanded behaviour intervention to include children as active learners with an emphasis on developmentally appropriate implementation using natural contingencies. Currently, there is a plethora of early intervention options but it is unclear which interventions...

    “Everyone says ‘safe sex’ but no one ever says ‘safe drugs’, you know?”: Perspectives on the intersection of drug checking services, drug policy and the overdose crisis

    by Jeff Ondocsin, Lissa Moran, Daniel Ciccarone, Simon Outram, Dan Werb, Nicole Holm, Emily A. Arnold

    Background

    Overdose deaths have continued to rise in the US despite heightened public attention and resources. Drug checking shows promise for integration into existing services for people who use drugs (PWUD) across North America. Amidst the backdrop of rising overdose deaths and emerging funds for harm reduction initiatives, this manuscript explores the landscape of drug checking services in North America and perspectives on improved integration with a diverse set of PWUD based in San Francisco and North American drug checking experts.

    Methods

    Two separate samples of drug checking stakeholders, ‘providers’ and ‘clients’ were recruited. Providers participated in in-depth semi-structured qualitative interviews over Zoom on their experiences advocating for and operating drug checking services in the US and Canada. Clients were people who used drugs and lived in or commuted to the San Francisco Bay Area and participated in semi-structured interviews in November 2022. Interviews were transcribed fully and analyzed using thematic analysis methods.

    Results

    Providers and clients identified ongoing instability in the North American drug supply that is exacerbating overdose risk while also identifying groups that would benefit from greater access to drug checking services. Both groups believed the paradoxical impacts of the fentanyl crisis at the core of drug checking services created barriers to the implementation and expansion of these services, hurting PWUD and their providers. Additionally, clients and providers reflected on the social and policy challenges to expansion and improvement of drug checking in their communities.

    Conclusion

    Drug checking remains underleveraged, particularly with respect to the most vulnerable PWUD. Clients and providers contended that these services must become more responsive to an ever changing and dangerous drug supply in North America.

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