Uptake of health economic evaluations alongside clinical trials in Australia: an observational study.
Abstract Background: Australia's clinical trials sector is highly productive with continued sector investment needed to enhance research impact. Generating economic evidence alongside trials has the potential to facilitate the implementation of trial results into practice. Ascertaining the use of health economic evaluations alongside clinical trials can assist in determining whether clinical trials fully realize and operationalize their potential to change policy and practice. The aims of this study were to ascertain the uptake of health economic evaluations alongside Australian-led clinical trials and explore associations between uptake and trial characteristics. Methods: This observational study comprised a descriptive analysis of clinical trials registries, [...]
Variation in initial biopsy technique for primary melanoma diagnosis: A population-based cohort study in New South Wales, Australia.
Abstract Background: Factors associated with nonadherence to guideline-recommended complete excision of suspicious cutaneous lesions are unclear. Objective: The purpose of this study was to analyze patient, melanoma, and clinician factors associated with initial diagnostic biopsy type and determine whether unwarranted variation from guidelines occurred. Methods: This population-based, cohort study involved the analysis of data from questionnaires completed by clinicians who managed patients with newly diagnosed, histopathologically confirmed primary invasive cutaneous melanomas reported to the New South Wales Cancer Registry between 2006 and 2007. Results: Of the 2267 biopsies, complete excision was attempted in 69.1% of cases but histologically incomplete in 14.0%. Multivariable regression [...]
Acceptability and timing considerations when administering patient-reported outcome measures (PROMs) among people with chronic health conditions who are culturally and linguistically diverse (CALD): a qualitative study protocol.
Abstract Introduction: Patient-reported outcome measures (PROMs) are validated and standardised questionnaires that capture patients' own reports of their symptoms, functioning and well-being. PROMs can facilitate communication between patients and clinicians, reduce symptom burden, enhance quality of life and inform health service re-design. We aim to determine the acceptability of PROMs and the preferred timing of PROM completion in New South Wales (NSW) at the point of care, facilitated by the Health Outcomes and Patient Experiences (HOPE) platform. Methods and analysis: Semi-structured interviews with patients (~50-75, sampling across seven language groups and seven clinical cohorts), carers (~10-20) and clinicians (~18) enrolled in [...]
Criteria for assessing evidence for biomarker-targeted therapies in rare cancers-an extrapolation framework.
Abstract Background: Advances in targeted therapy development and tumor sequencing technology are reclassifying cancers into smaller biomarker-defined diseases. Randomized controlled trials (RCTs) are often impractical in rare diseases, leading to calls for single-arm studies to be sufficient to inform clinical practice based on a strong biological rationale. However, without RCTs, favorable outcomes are often attributed to therapy but may be due to a more indolent disease course or other biases. When the clinical benefit of targeted therapy in a common cancer is established in RCTs, this benefit may extend to rarer cancers sharing the same biomarker. However, careful consideration of [...]
The use of linked administrative data in Australian randomised controlled trials: A scoping review.
Abstract Background/aims: The demand for simplified data collection within trials to increase efficiency and reduce costs has led to broader interest in repurposing routinely collected administrative data for use in clinical trials research. The aim of this scoping review is to describe how and why administrative data have been used in Australian randomised controlled trial conduct and analyses, specifically the advantages and limitations of their use as well as barriers and enablers to accessing administrative data for use alongside randomised controlled trials. Methods: Databases were searched to November 2022. Randomised controlled trials were included if they accessed one or more Australian [...]
Methods to Include Environmental Impacts in Health Economic Evaluations and Health Technology Assessments: A Scoping Review
Abstract Objectives: The environmental impacts of healthcare are important factors that should be considered during health technology assessments. This study aims to summarize the evidence that exists about methods to include environmental impacts in health economic evaluations and health technology assessments. Methods: We identified records for screening using an existing scoping review and a systematic search of academic databases and gray literature up to September 2023. We screened the identified records for eligibility and extracted data using a narrative synthesis approach. The review was conducted following the JBI Manual for Evidence Synthesis and reported according to the Preferred Reporting Items for [...]
Impact of whole brain radiotherapy after treatment of melanoma brain metastases on an individual’s employment and household income
Abstract Purpose: A cancer diagnosis can result in a considerable financial burden to individuals and their households. This study aimed to investigate this problem in patients treated for melanoma brain metastases. Methods: An economic evaluation was conducted as a sub-study of a randomised controlled trial of whole brain radiotherapy (WBRT) versus observation following surgery and/or stereotactic radiosurgery (SRS) for 1-3 melanoma brain metastases. Employment status and pre-tax household income were measured at baseline and every 2 months for 12 months. Outcomes included changes in employment status or household income category at 12 months. Results: Of 125 patients, 64 were [...]
Correction: Exploring the Integration of Environmental Impacts in the Cost Analysis of the Pilot MEL-SELF Trial of Patient-Led Melanoma Surveillance
No abstract available Read Full Paper
Transforming nursing assessment in acute hospitals: A cluster randomised controlled trial of an evidence-based nursing core assessment (the ENCORE trial).
Abstract Background: Patient safety is threatened when early signs of clinical deterioration are missed or not acted upon. This research began as a clinical-academic partnership established around a shared concern of nursing physical assessment practices on general wards and delayed recognition of clinical deterioration. The outcome was the development of a complex intervention facilitated at the ward level for proactive nursing surveillance. Methods: The evidence-based nursing core assessment (ENCORE) trial was a pragmatic cluster-randomised controlled trial. We hypothesised that ward intervention would reduce the incidence of patient rescue events (medical emergency team activations) and serious adverse events. We randomised 29 general [...]