Within the UK there are 33 deaths every day from prostate cancer, second only to lung cancer as the most common cause of cancer death in males in the UK. Of the 55 000 new cases each year, up to 50% of these patients will receive radiotherapy either alone or after prostatectomy. Although there have been significant improvements in the accuracy of radiotherapy delivery leading to better tumour targeting and a reduction in dose to normal tissues, significant permanent genito-urinary or gastrointestinal-related side effects are all too common. With nearly 80% of patients with prostate cancer surviving for 10 years or more, minimising life-limiting radiation damage to normal tissues is vitally important. However, at present, it is not possible to identify which patients will suffer a poorer outcome after radiotherapy. The aim of this study, improving radiotherapy in PROState cancer using EleCtronic population-based healthCAre data (PROSECCA), is to do this by using the existing information in a patient’s digital healthcare record. By linking primary, secondary and tertiary clinical data, including digital image information, with radiotherapy treatment plans and outcome data, the PROSECCA study will identify de novo predictive biomarkers of radiation response and provide clinicians with a tool to individualise a radiotherapy dose and plan to maximise cure and minimise toxicity.

The PROSECCA study is a large multidisciplinary project, the purpose of which is to analyse healthcare records from up to 15 000 patients with prostate cancer who underwent radiotherapy in the treatment of their cancer in Scotland between 2010 and 2022. Through the linkage of data obtained specifically for radiotherapy and data held within each patient’s unique electronic health record (EHR), the factors that indicate why some patients have a poor response to treatment, or an increased risk of side effects from radiation, will be identified. This will be made possible by the use of artificial intelligence and machine learning (AL/ML), which will help to identify at-risk patients earlier and allow adaptation of their treatment accordingly.

The study is being conducted in accordance with the ethical principles set out in the Declaration of Helsinki and Good Clinical Practice that respects and protects the rights, and maintains confidentiality, of all trial participants. The study protocol (V.1.0) was reviewed by the South Central Oxford A Research Ethics Committee (REC) on 13 December 2021 and received a favourable opinion subject to each National Health Service (NHS) organisation confirming permission for patients treated within their area. Approval for the use of unconsented healthcare record data for patients included in the study and treated at one of the five Scottish Cancer Centres required an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP). Full approval from the HSC-PBPP panel was received on 1 July 2024, which covered the use of pseudoanonymised EHR data for all patients participating in the study. The study is publicly listed on the NHS Health Research Authority site, with IRAS ID 306245 and REC reference 21/SC/0402. Dissemination of the study findings will take place through field-leading cancer, radiation oncology and medical physics journals. All manuscripts will be approved by the main study team and authorship determined by mutual agreement.

NCT06714630.

Major haemorrhage is the leading cause of preventable death in trauma, and prehospital blood transfusion may improve survival and outcomes for patients with prolonged out-of-hospital times. Globally, there is increasing interest in the use of whole blood in the prehospital environment, with randomised controlled trials ongoing. However, the results of these studies may not be generalisable to the longer out-of-hospital times seen in the Canadian trauma environment. The aim of this trial is to determine the feasibility of performing a randomised clinical trial evaluating the use of leukocyte-reduced whole blood transfusion compared with component blood transfusion in the Canadian prehospital environment. The secondary objective is to explore whether whole blood transfusion is better in reducing the proportion of patients who die or require massive transfusion within 24 hours.

This is a multi-centre, open-label, randomised controlled feasibility trial. Patients aged 16 years or older will be eligible if they have suffered a major traumatic haemorrhage, are attended by the provincial air ambulance service and require a prehospital blood transfusion. The primary outcome is feasibility as measured by the following metrics: proportion of patients enrolled with full data collection, proportion of patients who received at least one prehospital transfusion prior to arriving at the receiving trauma centre, proportion of patients who completed transfusion of all assigned blood units, number of patients unable to be enrolled due to lack of whole blood availability and number of whole blood units produced for the study that were wasted or expired. The secondary outcome is a composite outcome of death (all-cause mortality) or receipt of massive transfusion (receipt of 10 units of blood or more) within the first 24 hours from randomisation. We plan to recruit 60 patients, with an anticipated post-randomisation exclusion of ~10 patients for traumatic cardiac arrest or who do not meet eligibility criteria.

Provincial ethics approval was obtained (Clinical Trials Ontario REB ID: CTO-4921). An opt-out consent model will be employed for participants. The SWiFT Canada trial will recruit 60 patients through the provincial air ambulance organisation in Ontario who are transported to one of the six participating lead trauma centres. It will investigate the feasibility of a pre-hospital transfusion clinical trial in Canada to compare the effectiveness of whole blood compared with component blood therapy in a future definitive trial.

ClinicalTrials.gov: NCT06495294 (https://clinicaltrials.gov/study/NCT06495294), Clinical Trials Ontario: CTO-4921.

Preventable hospital patient harm events disproportionally affect certain patient populations. For some, harm extends beyond physical injury to include cultural, emotional or spiritual impacts. While these disparities are linked to socio-demographics (eg, race, education), they are driven by structural factors (eg, procedures and policies). Patient safety monitoring systems (eg, incident reporting, patient concerns) were not originally designed to identify equity-related harms and may inadvertently obscure or reinforce the injustices they should address. This study will examine how equity is currently considered within hospital incident reporting and patient concerns systems across Canada and will identify opportunities to strengthen these systems’ responsiveness to inequities in patient safety.

This 3-year exploratory sequential mixed-method study began in September 2024. Phase one involves qualitative interviews with patient safety and equity leads, patients/families/caregivers and leaders of innovative initiatives to explore current practices, gaps and innovations in how equity-related factors are identified and addressed within incident reporting and patient concerns systems. Findings will inform Phase 2, a modified Delphi process with patient safety and equity experts and persons with lived experience of equity-related harm events to refine and reach consensus on key equity-promoting features, considerations and recommendations for these systems. In Phase 3, consensus items will be used to develop a national cross-sectional survey assessing the extent to which equity is integrated into hospital incident reporting and patient concerns systems in Canada. A patient advisory committee will inform data collection, interpretation of findings and dissemination.

Ethics approval has been received for Phase 1, with subsequent approvals to be sought for later phases. Dissemination plans include peer-reviewed publications, presentations at international conferences and knowledge exchange activities to inform patient engagement, the design of incident reporting and patient concerns systems and policy development.