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Digital patient decision aids for endometriosis management: a scoping review protocol

Por: Pittet · O. · Delvallee · M. · Pluchino · N. · Selby · K. J. · Elwyn · G. · Durand · M.-A.
Introduction

Endometriosis is a chronic, oestrogen-dependent condition with a wide range of symptoms and comorbidities that significantly affect physical, emotional and psychological well-being, as well as quality of life. Women with endometriosis often face complex treatment decisions with no universally accepted gold-standard therapy. Shared decision-making, supported by patient decision aids (PtDAs), can enhance patient knowledge and promote informed preferences and decisions. Digital PtDAs, in particular, offer potential for personalised, interactive and accessible decision support. Their characteristics, development process and evaluation in endometriosis care remain underexplored. The objective of this scoping review is to map the existing literature on digital PtDAs developed for women of reproductive age (18–49) with endometriosis, across a range of healthcare and digital health contexts.

Methods and analysis

This scoping review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews. A comprehensive three-step search, developed with an information specialist, will be conducted across MEDLINE (PubMed), CINAHL, Embase, Web of Science, Cochrane databases and grey literature sources. Citations will be imported into Rayyan for screening. Two independent reviewers will conduct study selection, data extraction and analysis. Data will be summarised using tables and descriptive content analysis to identify key features, development processes and evaluation methods of digital PtDAs. The review will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Ethics and dissemination

This review started off in July 2025, and the anticipated end date is November 2025. We plan to disseminate this research through publications, presentations at relevant national and international conferences and meetings with relevant stakeholders. This scoping review protocol has been registered at Open Science Framework (osf.io/fp86m). As this scoping review will use data from published and publicly available sources, research ethics approval is not required.

Preventing kidney injury using carbon dioxide (KID trial): trial protocol for a multicentre randomised controlled trial

Por: Saratzis · A. · Rasheed · N. · Aguirre · D. · Coughlin · P. · Diamantopoulos · A. · Bearne · L. · Selby · N. M. · Brookes · C. · Barber · S. · Richardson · C. · Gilbert · H. · Schueller · R. · Apergi · D. · Harris · K. J.
Introduction

Peripheral arterial disease (PAD) commonly coexists with chronic kidney disease (CKD). Patients with symptomatic PAD often require endovascular revascularisation to relieve pain or salvage limbs. However, the iodinated intra-arterial contrast routinely used in these procedures is nephrotoxic, placing patients with CKD at increased risk of acute kidney injury (AKI) and long-term renal decline. Carbon dioxide (CO2) delivered via automated injection is a potential alternative imaging contrast medium. This trial will evaluate whether using CO2 instead of iodinated contrast reduces the risk of AKI and short-term renal function decline in this high-risk group.

Methods and analysis

This is a multicentre, open-label, prospective randomised controlled trial across six secondary-care National Health Service (NHS) vascular surgery centres. A total of 174 patients with PAD and CKD undergoing endovascular intervention will be randomised 1:1 to receive iodinated contrast (standard of care) or CO2 via automated injector (Angiodroid). All perioperative care will follow local NHS protocols.

The primary outcome is log serum creatinine at 2, 30 and 90 days postprocedure. Key secondary outcomes include: incidence and severity of AKI within 48 hours postprocedure, major adverse kidney events (death, dialysis or >25% estimated glomerular filtration rate decline) by 90 days, inpatient length of stay, procedural pain, quality of life, procedural success, reinterventions, acceptability and feasibility (patient/practitioner questionnaires) of using CO2, and cost-effectiveness (healthcare resource use analysis). A mixed-methods process evaluation will be undertaken with patients and clinicians.

Ethics and dissemination

The trial has been approved by an NHS ethical review committee (24/WA/0332) and patients have been involved in trial design. Findings will be disseminated to participants, clinicians and the wider public through patient groups, lay summaries, social media, conferences, peer-reviewed journals and NHS policy channels.

Trial registration number

ISRCTN23564393.

Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID): protocol for a randomised controlled adaptive platform trial of treatments for acute SARS-CoV-2 infection in community settings

Por: Hosseini · B. · Condon · A. · da Costa · B. R. · Daley · P. · Greiver · M. · Jüni · P. · Lee · T. C. · McBrien · K. · McDonald · E. G. · Murthy · S. · Selby · P. · Andrew · M. · Aubrey-Bassler · K. · Barber · D. · Barrett · B. · Butler · C. C. · Crampton · N. · Dahrouge · S. · Damji · A.
Introduction

SARS-CoV-2 is now endemic and expected to remain a health threat, with new variants continuing to emerge and the potential for vaccines to become less effective. While effective vaccines and natural immunity have significantly reduced hospitalisations and the need for critical care, outpatient treatment options remain limited, and real-world evidence on their clinical and cost-effectiveness is lacking. In this paper, we present the design of the Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID). By evaluating multiple treatment options in a pragmatic adaptive platform trial, this study will generate high-quality, generalisable evidence to inform clinical guidelines and healthcare decision-making.

Methods and analysis

CanTreatCOVID is an open-label, individually randomised, multicentre, national adaptive platform trial designed to evaluate the clinical and cost-effectiveness of therapeutics for non-hospitalised SARS-CoV-2 patients across Canada. Eligible participants must present with symptomatic SARS-CoV-2 infection, confirmed by PCR or rapid antigen testing (RAT), within 5 days of symptom onset. The trial targets two groups that are expected to be at higher risk of more severe disease: (1) individuals aged 50 years and older and (2) those aged 18–49 years with one or more comorbidities. CanTreatCOVID uses numerous approaches to recruit participants to the study, including a multifaceted public communication strategy and outreach through primary care, outpatient clinics and emergency departments. Participants are randomised to receive either usual care, including supportive and symptom-based management, or an investigational therapeutic selected by the Canadian COVID-19 Outpatient Therapeutics Committee. The first therapeutic arm evaluates nirmatrelvir/ritonavir (Paxlovid), administered two times per day for 5 days. The second therapeutic arm investigates a combination antioxidant therapy (selenium 300 µg, zinc 40 mg, lycopene 45 mg and vitamin C 1.5 g), administered for 10 days. The primary outcome is all-cause hospitalisation or death within 28 days of randomisation.

Ethics and dissemination

The CanTreatCOVID master protocol and subprotocols have been approved by Health Canada and local research ethics boards in the participating provinces across Canada. The results of the study will be disseminated to policy-makers, presented at conferences and published in peer-reviewed journals to ensure that findings are accessible to the broader scientific and medical communities. This study was approved by the Unity Health Toronto Research Ethics Board (#22-179) and Clinical Trials Ontario (Project ID 4133).

Trial registration number

NCT05614349

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