The Validating Outcomes by Including Consumer Experience (VOICE) project is developing patient reported experience measure (PREM) tools to collect consumer feedback for Indigenous primary healthcare (IPHC) services’ accreditation and quality improvement processes. This study aimed to explore the views of health service staff about: (1) optimising the feasibility of collection, analysis and interpretation of findings; and (2) resourcing requirements for implementation of the PREM.

A participatory action research qualitative study design, guided by an Indigenous advisory group. Our team of Indigenous and non-Indigenous researchers conducted semistructured focus groups and individual interviews with IPHC staff. Focus groups and interviews were recorded, transcribed and thematically analysed. Multiple sense-making meetings were conducted with the Indigenous advisory group.

Eight partner IPHC services across four Australian states and territories.

All staff were eligible and invited to participate in the study via purposive and snowball sampling. Administrative staff (eg, receptionist, programme facilitator), clinicians/practitioners (eg, general practitioner, nurse, Aboriginal and Torres Strait Islander health workers and practitioners) and service managers (eg, CEO, practice manager) from partner health services participated.

63 staff participated; 44 attended across 13 focus groups, with the remainder participating in individual interviews. The majority of participants were between 35 years and 55 years old (52%), female (66%) and working in frontline IPHC service delivery roles (56%). Equal numbers identified as Indigenous (50%) and non-Indigenous (50%). Many had worked in the Indigenous health and well-being sector for over 10 years (40%). ‘Culturally safe care’ and ‘accountability’ were identified as primary themes and key reasons for gathering consumer feedback. Subthemes identified were ‘Relationships’, ‘trust and respect’, ‘communication about consumer feedback’, ‘timing and frequency of requesting consumer feedback’, ‘health service systems’, ‘health service and staff capacity’, ‘staff skills’ and ‘structure and administration of the PREM’. All themes and subthemes need to be considered for the successful design and implementation of PREMs in IPHC settings.

Many of the issues identified are not currently considered in the process of collecting PREM data for accreditation yet, if addressed, would likely improve the quality and relevance of data collected. The findings from this study will inform the co-design and validation of Indigenous-specific PREM tools to collect consumer feedback. Critically, service and community input will ensure the PREM tools meet service needs for continuous quality improvement and accreditation and reflect the priorities and values of Indigenous peoples.

To investigate the prognostic value of the Subgroups for Targeted Treatment (STarT) Screening Tool adapted for concussion (STarT-C) on persistent symptoms and disability at 6–9 months following mild traumatic brain injury (mTBI).

Secondary analysis of two prospective studies: an observational cohort study in New Zealand and usual care control arm of a clinical trial in Canada (ClinicalTrials.gov Registry (NCT04704037)).

Participants in the New Zealand cohort were recruited from concussion clinics (five sites) and those in the Canadian cohort were recruited from emergency departments/urgent care centres (eight sites).

New Zealand participants (n=93, median age 37 years, 60% women) were assessed at median=6 weeks post-injury (T1) and 6 months later (T2). Canadian participants (n=223, median age 38 years, 56% women) were assessed at median=2 weeks (T1) and 6 months later (T2).

Symptoms at T2 were assessed using the validated Rivermead Postconcussion Symptoms Questionnaire (RPQ) and disability using the WHO Disability Assessment Schedule 2.0 12-item Interview.

In linear regression analyses, the STarT-C predicted symptom burden (R²=18–36%) and disability (R²=15–18%) at T2 in both cohorts. While the additional prognostic value over and above baseline variables was substantial (delta R² 8–40%), the additional prognostic value over the RPQ at T1 was variable and generally lower (delta R²=1–9%).

The STarT-C—a brief screening tool—predicted persistent symptoms and disability in adults following mTBI. The incremental prognostic value of the STarT-C over the RPQ may be variable, but regardless, the tool may be useful for identifying those at risk of prolonged recovery who may benefit from early psychological intervention.

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.

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.

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.

Primary and secondary outcomes will be published on trial completion.

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.

NCT05096195.